Systems and methods for bariatric therapy

The present invention provides bariatric therapy systems. One system includes a gastrointestinal implant device and a delivery mechanism therefor. The device can include a sleeve for placement into a small intestine and to minimize absorption of nutrients by its walls. An anchoring mechanism coupled to a proximal end of the sleeve and designed to be secured within the stomach can be provided. A passageway extending through the anchoring mechanism and the sleeve can also be provided, along which food can be directed from the stomach to the small intestine. The delivery mechanism can include a housing for accommodating the device, and a deploying balloon situated within the housing and which can be actuated to direct the sleeve of the device from within the housing to the site of implantation. Methods for providing bariatric therapy are also provided by the present invention.

BACKGROUND

According to the Center for Disease Control (CDC), over sixty percent of the United States population is overweight, and almost twenty percent are obese. This translates into about 38.8 million adults in the United States with a Body Mass Index (BMI) of 30 or above. The BMI is generally defined as the weight (e.g., in kilograms) of an individual divided by the height (e.g., in meters) of the individual, squared. To be considered clinically, morbidly obese, one must meet one of three criteria: BMI over 35, 100 lbs. overweight, or 100% above ideal body weight. There is also a category for the super-obese for those weighing over 350 lbs.

Obesity is thus an overwhelming health problem in the U.S. Moreover, because of the enormous strain associated with carrying this excess weight, organs are affected, as are the nervous and circulatory systems in an individual who is overweight or obese. In 2000, the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) estimated that there were 280,000 deaths directly related to obesity. The NIDDK further estimated that the direct cost of healthcare in the US associated with obesity is $51 billion. In addition, Americans spend approximately $33 billion per year on weight loss products. In spite of this economic cost and consumer commitment, the prevalence of obesity continues to rise at alarming rates. From 1991 to 2000, obesity in the US grew by about 61%. Not exclusively a US problem, worldwide obesity percentages are also increasing dramatically.

There have been many attempts in the past to surgically modify anatomies of a patient to address the consumption problem by reducing the desire to eat. Stomach staplings, or gastroplasties, in order to reduce the volumetric size of the stomach, therein achieving faster satiety, were initially performed in the 1980's and early 1990's. Although able to achieve early weight loss, sustained reduction in connection with gastroplasties was not obtained. The reasons are not all known, but are believed to be related to several factors. One of which is that the stomach stretches over time, thereby increasing volume, while psychological drivers motivate patients to find creative approaches to literally eat around the smaller pouch.

Space-occupying gastric balloons have also been used to treat obesity since the 1980's. One such balloon is described by Garren et al. (U.S. Pat. No. 4,899,747 Method and apparatus for treating obesity). Gastric balloons are generally designed to decrease the functional volume of the stomach.

Similarly, intestinal sleeves are also being used for obesity treatment (Levine et al., U.S. Pat. No. 7,347,875 Methods of treatment using a bariatric sleeve; Levine et al. U.S. Pat. No. 7,025,791 Bariatric sleeve). These sleeves consist of an anchoring mechanism that attaches at one end of a thin walled plastic sleeve and extends from the pylorus to allow the sleeve to extend past the Ligament of Treitz. Intestinal sleeves function to decrease absorption from the portion of bowel covered by the sleeve. Presently, a guidewire is advanced into the patient's jejunum under fluoroscopic guidance (Gersin K S, Keller J E, Stefanidis D, et al. Duodenal jejuna bypass sleeve: A totally endoscopic device for the treatment of morbid obesity. Surg Innov 2007:14; 275). A gastroscope is then used to deploy the stent-like anchor in the pylorus, and gastroscopic instruments; e.g. graspers, are used to hold the sheath and advance it along the intestine to the Ligament of Treitz. However, complications often associate with delivery of intestinal sleeves. In addition, the sleeves are difficult to manipulate, and especially the current methods for advancing the sleeves along the intestine are time consuming and inefficient.

In another approach, an open bariatric surgical procedure known as the “Roux-en-Y” procedure, a small stomach pouch is created by stapling part of the stomach together. This small pouch can limit how much food an individual can eat. In addition, a Y-shaped section of the small intestine is attached to the pouch to allow food to bypass the duodenum as well as the first portion of the jejunum. This causes reduced calorie and nutrient absorption. Common problems associated with Roux-en-Y include pouch stretching, where the stomach gets bigger overtime and can stretch back to its original size over time; a breakdown of staple lines where the staples fall apart and reverse the procedure; and a leakage of stomach contents into the abdomen (this is dangerous because the acid can eat away other organs. In addition, as the Roux-en-Y procedure requires open surgery, it is a painful, time-consuming operation and requires relatively long recovery time.

Accordingly, it would be desirable to have an effective system for bariatric therapy, reducing the harmful side effects such as painful surgical operations. In particular, there is a need for effective systems and delivery mechanisms for bariatric therapy that can minimize complications and recovery time, reduce operation time and resources, and improve therapy efficiency, success rate, and safety.

SUMMARY OF THE INVENTION

The present invention provides, in an embodiment, a gastrointestinal implant device. The gastrointestinal implant device can include a sleeve for placement into a small intestine and to minimize absorption of nutrients by a wall of the small intestine. The sleeve, in an embodiment, may be made from a sufficiently flexible material to permit the sleeve to move between an inverted position and an everted position. In certain embodiments, the sleeve may be made from a material having substantially low permeability, so as to minimize absorption of nutrients from the digested food by the wall of the small intestine. The gastrointestinal implant device, in an embodiment, can also include an anchoring mechanism coupled to a proximal end of the sleeve and designed to be secured within a stomach, so as to allow the sleeve to securely extend into the small intestine. In some embodiments, the anchoring mechanism is designed to reduce functional volume of the stomach. The anchoring mechanism, in one example, can be an inflatable balloon sufficiently large to prevent the inflatable balloon from entry into the small intestine. To that end, the anchoring mechanism may include a port for inflating the anchoring mechanism. The anchoring mechanism may alternatively be a self-expanding frame which, upon expansion, can be substantially frustoconical in shape for securing against a wall of the stomach, while allowing the stomach to maintain a substantially full functional volume. The gastrointestinal implant device, in an embodiment, can further include a passageway extending through the anchoring mechanism and the sleeve, and along which digested food can be directed from the stomach into the small intestine.

The present invention further provides, in another embodiment, a bariatric therapy system. The system can include a gastrointestinal implant device. The device, in an embodiment, can include a sleeve for placement into a small intestine and to minimize absorption of nutrients by a wall of the small intestine. The device can also include an anchoring mechanism coupled to a proximal end of the sleeve and designed to be secured within a stomach so as to allow the sleeve to securely extend into the small intestine. In some embodiments, the anchoring mechanism can be an inflatable balloon designed to reduce functional volume of the stomach upon inflation and may be designed to include a port for inflating the anchoring mechanism. The anchoring mechanism, in certain embodiments, can also be a self-expanding frame which, upon expansion, can be substantially frustoconical in shape for securing against a wall of the stomach while allowing the stomach to maintain a substantially full functional volume. The device can further include a passageway extending through the anchoring mechanism and the sleeve, and along which digested food can be directed from the stomach to the small intestine. In addition to the device, the system can further include a delivery mechanism for directing the device to a site of implantation. The delivery mechanism, in an embodiment, can include a housing for accommodating the device. The housing can be provided with a delivery end, an opposing proximal end, and a passageway therebetween. In certain embodiments, the housing can be substantially tubular in shape and/or made from a sufficiently flexible material for accommodating the device. The delivery mechanism, in an embodiment, can also include a deploying balloon, situated within the passageway of the housing, for accommodating the sleeve of the device. The balloon may be provided with an open end attached to the delivery end of the housing and a closed end situated within the housing, such that in the presence of positive pressure within the passageway of the housing, the balloon can be everted from within the housing to direct the sleeve of the device into the small intestine. A port, in an example, can be provided on the housing through which positive pressure can be introduced into the housing. The port, in an embodiment, can be provided with an inflation device detachably connected thereto. In addition, a gastroscope for guiding the system to the site of implantation can also be provided for use in connection with the system of the present invention.

The present invention also provides, in another embodiment, a delivery mechanism. The delivery mechanism can include a housing. The housing can be provided with a delivery end, an opposing proximal end, and a passageway therebetween. The delivery mechanism, in an embodiment, can also include a deploying balloon, situated within the passageway of the housing, for accommodating a sleeve of an implant device. The balloon may be provided with an open end attached to the delivery end of the housing and a closed end situated within the housing, such that in the presence of positive pressure within the passageway of the housing, the balloon can be everted from within the housing to direct the sleeve of the device into the small intestine. In some embodiments, the housing can be a reservoir capable of expanding to permit eversion of the balloon from within the passageway of the housing. In certain embodiments, the delivery mechanism can further include a port through which positive pressure can be introduced into the passageway of the housing to evert the balloon from within the passageway. To that end, the delivery mechanism may further include an inflation device detachably connected to the port and designed to introduce positive pressure into the housing via the port to deploy the implant device. In addition, a gastroscope for guiding the delivery mechanism to the site of implantation can also be provided for use in connection with the delivery mechanism of the present invention.

The present invention additionally provides, in another embodiment, a method for providing bariatric therapy. The method can include everting a sleeve from an inverted position into a small intestine. In an embodiment, positive pressure can be used to cause eversion of the sleeve. The method can further include anchoring the sleeve at its proximal end adjacent a pyloric junction between stomach and mall intestine. The anchoring step, in an embodiment, can include securing an anchoring mechanism coupled to a proximal end of the sleeve within the stomach so as to allow the sleeve to securely extend into the small intestine. The method, in some embodiments, can further include allowing digested food to be directed from the stomach through the anchoring mechanism into the sleeve, while minimizing absorption of nutrients from the digested food by a wall of the small intestine. In addition, to the extend desired, the method can further include guiding the sleeve to a site of implantation with a gastroscope.

The present invention further provides, in an embodiment, another gastrointestinal implant device. The device includes a plurality of struts that are interconnected to define an expandable body. In some embodiments, the expandable body is sufficiently elastic and capable of contracting and expanding along with stomach peristalsis without being expelled therefrom. The expandable body may also be designed to exert a pressure against a wall of the stomach to distend the stomach and provide a feeling of satiety upon expansion. In addition, the expandable body may include an expandable mechanism which, upon expansion, reduces a functional volume of the stomach. The device additionally includes a plurality of openings situated between the struts, the openings designed to allow food to enter into the expandable body through a first opening and to exit from the expandable body through a second opening. The device further includes a sleeve having an entrance that is coupled to the expandable body, such that the entrance is in alignment with the second opening to direct the food into the sleeve. In certain embodiments, the sleeve is designed for placement into a small intestine and to minimize absorption of nutrients by a wall of the small intestine.

The present invention also provides, in a further embodiment, yet another gastrointestinal implant device. The device includes a first anchoring mechanism designed to be secured along a gastrointestinal tract and within a stomach. The first anchoring mechanism, in an embodiment, is expandable to reduce a functional volume of the stomach. The device further includes a second anchoring mechanism coupled to and spaced from the first anchoring mechanism, the second anchoring mechanism being designed to be secured further along the gastrointestinal tract and beyond the stomach. In an embodiment, the second anchoring mechanism is designed to be secured within a duodenum by exerting a radial force against a wall of the duodenum. The second anchoring mechanism may be coupled to the first anchoring mechanism via a tethering mechanism. For example, the tethering mechanism may be a proximal portion of the sleeve, or one or more tethers. The tethering mechanism, in an embodiment, may be sufficiently elastic to allow the first and/or second anchoring mechanism to exert a compressive force on a pylorus, so as to maximize anchoring of the first and second anchoring mechanisms adjacent the pylorus. The device additionally includes a sleeve coupled to and positioned outside the second anchoring mechanism, the sleeve being designed for placement into a small intestine and to minimize absorption of nutrients by a wall of the small intestine. In an embodiment, the sleeve is circumferentially situated about an outer surface of the second anchoring mechanism. In some embodiments, the second anchoring mechanism may be designed to expand to contact the wall of the duodenum, so as to seal the sleeve against the wall of the duodenum.

The present invention additionally provides, in an embodiment, another method for providing bariatric therapy. The method includes first securing a first anchoring mechanism along a gastrointestinal tract and within a stomach. In an embodiment, the securing step includes expanding the first anchoring mechanism to contact a wall of the stomach. The method also includes positioning a second anchoring mechanism further along the gastrointestinal tract and beyond the stomach, the second anchoring mechanism being coupled to and spaced from the first anchoring mechanism. The positioning step, in an embodiment, includes expanding the second anchoring mechanism within a duodenum so as to contact a wall of the duodenum. The method further includes placing a sleeve about an outer surface of the second anchoring mechanism to permit the sleeve to extend into a small intestine, and to minimize absorption of nutrients by a wall of the small intestine. The placing step may, for example, include situating the sleeve circumferentially about the outer surface of the second anchoring mechanism. In an embodiment, the placing step includes everting the sleeve from an inverted position and allowing the sleeve to extend into the small intestine. The sleeve may be sealed against the wall of the duodenum, for example, by act of the second anchoring mechanism.

DESCRIPTION OF SPECIFIC EMBODIMENTS

In accordance with one embodiment of the present invention, a system is provided herein for bariatric therapy. One system, as described hereinafter, may be used to employ volume restriction within the stomach and/or enhance malabsorption within the small intestine. Such a system of the present invention includes, in one embodiment, a gastrointestinal implant device having an anchoring mechanism designed to be positioned within the stomach to anchor the device, and an intestinal sleeve attached at one end to the anchoring mechanism. The sleeve can be designed to extend along a portion of the small intestine to minimize or prevent nutrient absorption by the small intestine. In one embodiment, the anchoring mechanism may be a space occupying ring, an inflatable balloon, a self-expanding anchor or frame, or any combination thereof. As will be seen hereinafter, the system can also include a delivery mechanism for delivering or placing the device at a site of implantation.

Generally, food to be digested enters the stomach through the cardiac orifice from the esophagus. Once in the stomach, food is at least partially digested to produce chyme, a semi-fluid substance that can be homogeneous, creamy or gruel-like. Once produced, the chyme can then exit the stomach through the pylorus or pyloric junction and enter the small intestine. The pylorus is a distal aperture of the stomach surrounded by a strong band of circular muscle. The small intestine, about nine feet in length, is a convoluted tube, extending from the pylorus to the ileo-caecal valve where it terminates in the large intestine. The small intestine has three sections including the duodenum, jejunum and the ileum.

The duodenum has four sections including the superior, descending, transverse and ascending sections which typically form a U-shape. The superior section is about two inches long and ends at the neck of the gall bladder. The descending section is about three to four inches long and includes a nipple shaped structure (papilla of vater) through which pancreatic juice from the pancreas and bile produced by the liver and stored by the gall bladder can enter the duodenum from the pancreatic duct. The pancreatic juice typically contains enzymes essential to protein digestion and bile that can be used to dissolve the products of fat digestion. The ascending section, on the other hand, is about two inches long and forms the duodenal-jejunal flexure where it joins the jejunum, the next section of the small intestine. The duodenal-jejunal flexure is fixed to the ligament of Treitz (musculus supensionus duodeni). The juices secreted in the duodenum can break the partially digested food down into particles small enough to be absorbed by the body.

Referring now toFIG. 1A, a system100for providing bariatric therapy according to one embodiment of the present invention is shown. System100may include a gastrointestinal implant device105for facilitating weight loss. In one embodiment, the device105can be used to reduce the size of the stomach while simultaneously reducing absorption of food nutrients within the small intestine. In accordance to an embodiment of the present invention, the device105may include an intestinal sleeve130designed to extend from within the stomach and along a portion of the intestine below the pylorus, to minimize absorption of nutrients by the intestinal walls.

As illustrated, the sleeve130may include a proximal end132that may be designed for placement adjacent the pyloric junction, an area around the pylorus where the stomach and the small intestine meet. The sleeve130may further include a passageway136extending from the proximal end132to allow passage of food and other food material through sleeve130. As used herein, “food” or “other food material” can be used interchangeably; “food” can also include undigested, partially digested, and completely digested food. The sleeve130may further include a distal end134. The distal end134, in an embodiment, can be open-ended to provide an opening through which food and other food material can exit sleeve130.

The sleeve130, in an embodiment, can be designed to reduce absorption and digestion of food by the intestinal walls. In particular, sleeve130can line and cover the intestinal wall, and act to reduce absorption and digestion of food by delaying the mixing of food with bile and pancreatic juices until after the food exits the distal end134of sleeve130. In other words, by preventing the mixing of bile and pancreatic juices with food in the duodenum, digested (partially or completely) food material is not broken down into particles small enough to be absorbed by the body. As a result, the absorption of nutrients (e.g., fats and carbohydrates) is reduced.

To that end, the sleeve130can be made from any material that can aid in the passage of food through the sleeve130. In one embodiment, the sleeve130can be made from a material that minimizes resistance and friction so as to allow food to slide more easily through the sleeve. For instance, the sleeve130can be made from a material that is substantially smooth and/or has a relatively low coefficient of friction. The sleeve130material may further have substantially low permeability to fluids to minimize the occurrence of digested food leaking through the sleeve130and coming into contact with the intestinal wall where it can be absorbed. The sleeve130can also be made from any material that helps to minimize or prevent tissue in-growth, as well as a material that can be non-irritating to the bowel, so as to aid in the removal of the sleeve130, once removal is desired. Since the sleeve130can be designed to be implanted within an intestine of a human or animal body, the sleeve130should also be made from a material that is biocompatible. The biocompatibility of the material may help minimize occurrence of adverse reactions due to constant contact of the sleeve130with the gastrointestinal tract. In an embodiment, the sleeve130can be made from any material that can be obtained commercially.

Should it be desired, sleeve130may further include a coating that can aid in reducing absorption of nutrients, minimize resistance to provide a smooth passageway for food, minimizing porosity, preventing tissue in-growth, allowing subsequent removal of the device from the intestinal tract, or any other characteristic that may be desirable for the sleeve130. The coating may be applied to the sleeve130on an inner surface, an outer surface, or a combination thereof to minimize any porous characteristics of the sleeve material.

In one embodiment, the sleeve130can also be made from any material that allows the sleeve130to expand and collapse in accordance with the digestive process. When food enters and passes through the sleeve130, the sleeve material can be such that it may allow the sleeve130to expand sufficiently to accommodate the digested food. Once the food from the stomach has passed through the sleeve130, however, the sleeve material can be such that is may allow the sleeve130to become flexible or floppy, permitting the sleeve130to contour toward one side of the intestine. In this floppy state, the sleeve130may permit the pancreatic juice to flow with minimal resistance into the duodenum through the papilla of vater. Of course, in some instances, it may be desirable for the sleeve130to maintain a substantially constant form throughout the digestive process. In these instances, the sleeve130may be made from a material that can maintain such a substantially constant form.

The length of the sleeve130may, in an embodiment, vary depending on a variety of characteristics. In certain instances, the length of the sleeve130may be dependent on the patient's Body Mass Index (BMI). In other instances, the length of the sleeve130may be selected based on the amount of absorption desired. A longer sleeve130, for example, may minimize absorption of nutrients by the intestinal walls over a longer distance than a shorter sleeve130. In some instances, the length of the sleeve130may be selected based on the distance necessary to bypass the duodenum and allow the sleeve130to couple with the jejunum. It should be noted that the length of the sleeve130should also permit the sleeve130to fit within the delivery mechanism115as well as within the intestine.

The sleeve130may have any shape desirable, so long as the shape allows the sleeve130to fit within the intestine. In one embodiment, the sleeve130may have a substantially tubular shape to allow the sleeve130to substantially conform to the intestine. Of course, other geometric shapes may be possible.

The sleeve130may further have any diameter desirable so long as the diameter allows food to travel through the sleeve130without substantial hindrance. In one embodiment, the sleeve130may have a diameter to allow the sleeve130to substantially conform to the intestinal walls when in an expanded state. By substantially conforming to the intestinal walls in an expanded state, the sleeve130can maximize the amount of food traveling through. Of course, smaller diameters may also be possible.

The gastrointestinal implant device105may further include, in accordance with an embodiment of the present invention, an anchoring mechanism140, coupled to the proximal end132of the sleeve130. The anchoring mechanism140may be designed to be positioned, in certain instances, in the stomach to anchor the device105thereat. In an embodiment, the anchoring mechanism140can be an anchor that acts to reduce the functional volume of the stomach. An example of such an anchoring mechanism140can be a space occupying inflatable ring or balloon, or any other anchoring mechanism140adapted to adequately engage and secure the proximal end132of the sleeve130at the pyloric junction, while reducing the volume of the stomach. In an embodiment, the anchoring mechanism140can be integral with the sleeve130at the proximal end132, so that the anchoring mechanism140and sleeve130are formed from one piece of material. Alternatively, the anchoring mechanism140can be separate and independent from the sleeve so that the anchoring mechanism and sleeve130are formed from two pieces of material and are coupled to one another.

FIG. 1Bshows the gastrointestinal implant device105in a deployed position. In particular, the anchoring mechanism140is positioned at a point within the stomach145just above the pylorus149. The proximal end134of the sleeve130, on the other hand, can extend from the anchoring mechanism140within the stomach145, across the pylorus149, and into the small intestine147. It should be appreciated that anchoring mechanism140can also extend into the pylorus149and proximal end134of the sleeve130can be situated adjacent the pylorus149. A passageway150, in an embodiment, can extend through the anchoring mechanism140and the sleeve130, so that food can be directed from the stomach145, into the device105and moved along the passageway150, and into the small intestine147.

As noted, the anchoring mechanism140can be designed, in certain instances, to facilitate weight loss by reducing the functional volume of the stomach145. In other words, by occupying a portion of the stomach145, the anchoring mechanism140can act to decrease the functional volume of the stomach145, and thus, the amount of food intake by the patient. To that end, The anchoring mechanism140, in an embodiment, may have any size desirable, depending on the particular application, as the size of the anchoring mechanism140may affect the functional volume by which the stomach145is reduced. For instance, a larger anchoring mechanism140may occupy a larger space within the stomach and may, accordingly, reduce the functional volume of the stomach by a larger amount than a smaller anchoring mechanism. It should be noted that the size of the anchoring mechanism140needs to permit the anchoring mechanism140to be securely positioned within the stomach at a site of implantation. That is, the anchoring mechanism140can be sufficiently large to prevent it from entry into the small intestine.

The anchoring mechanism140, as illustrated inFIGS. 1A-1B, may have a donut shape. A donut shape may allow the anchoring mechanism140to be positioned within the stomach, such that the anchoring mechanism140can substantially conform to the shape of the stomach and may, simultaneously, provide an exit for food to leave the stomach. Of course, other shapes for the anchoring mechanism140may be possible.

To adequately secure the anchoring mechanism140within the stomach, the anchoring mechanism140can be made from a material that can radially expand to exert a sufficient radial force to push the anchoring mechanism140against the walls of the stomach at the site of implantation. It should be appreciated that the material used should permit the anchoring mechanism140to conform to the dimensions of the stomach at the implantation site, even when the dimensions of the stomach vary. In one embodiment, an anti-inflammatory agent such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine, or any suitable combination or mixture thereof may be applied to the anchoring mechanism140to prevent inflammation or any other adverse reaction caused by the engagement of the anchoring mechanism140within the stomach.

In accordance with one embodiment, as illustrated inFIGS. 1A-1B, the anchoring mechanism140may be provided with a port or valve142to which an inflation mechanism may be detachably connected for inflation purposes. To that end, the valve can be a one-way valve designed to prevent premature and unintentional deflation and removal of the device105from the intestinal tract. The one-way valve may be an elastomeric plug, a spring loaded valve, or any other valve known in the art as the present invention is not intended to be limited in this manner.

An inflation mechanism (not shown) for inflating the anchoring mechanism140can include, for instance, an inflation catheter or any other inflation device capable of inflating the anchoring mechanism140. As the inflation mechanism can be detachably coupled to port or valve142of the anchoring mechanism140, the inflation mechanism can be disconnected and detached from the port or valve142of anchoring mechanism140following inflation. It should be appreciated that the anchoring mechanism140can be deflated when removal of the device105is desired.

Connection of the inflation mechanism to port or valve142of the anchoring mechanism140may occur, in certain embodiments, through the use of a connector (not shown). The connector can act to couple the inflation mechanism to the anchoring mechanism140allowing the inflation mechanism to inflate the anchoring mechanism140. In an embodiment, the connector may be situated on either the inflation mechanism or the anchoring mechanism140. Alternatively, the connector may include a two-piece design having two complimentary pieces to permit coupling between the inflation mechanism and the anchoring mechanism140. Examples of connectors include a mating luer connector, a metal tube, or any other connectors known in the art.

Although an inflation mechanism is described herein, it should be appreciated that the anchoring mechanism140can be self-expanding to allow expansion of anchoring mechanism140without the aid of additional inflation mechanisms. Such self-expanding mechanism, similar to a life vest, are known in the art.

Still referring toFIG. 1A, system100for providing bariatric therapy may further include, in an embodiment, a delivery mechanism115for delivering the gastrointestinal implant device105to a site of implantation. In an embodiment, the delivery mechanism115can include a housing110having a delivery end112, an opposing end114, and a passageway116therebetween. In one embodiment, the delivery end112can be designed to permit sleeve130of device105to be inserted (e.g., in an inverted position) into delivery mechanism115. In addition, the delivery end112may be sufficiently sized to permit anchoring mechanism140to be securely positioned about delivery end112.

In one embodiment, the housing110can be made from any material capable of passing through the intestine and delivering device105to a site of implantation. To that end, housing110may be formed from a substantially hard material, so as to minimize deformation of the housing110during delivery. Examples of materials that are substantially hard include metals, plastics, ceramics, or any other materials that can maintain a substantially consistent shape. Housing110can also be made from a sufficiently flexible material to permit compression of the housing110. For example, housing110may be formed from a thin-walled membrane such as nylon laminated with polyurethane.

Since the housing110is designed to be inserted into an intestine of a human or animal body, the housing110, in an embodiment, can be made from a material that is biocompatible. The biocompatibility of the material may help minimize occurrence of adverse reactions due to use of the housing110within an intestine. The housing110may further include a coating on an outer surface to reduce friction between the housing110and the intestinal wall upon insertion into the intestine. Likewise, the housing110may include a coating on an inner surface to reduce friction during deployment of the sleeve130situated within the housing110.

It should be appreciated that the housing110may be provided with any shape desirable, depending on the particular application, as the shape of the housing110may affect ability of the housing110to deliver the device105to a site for implantation. For instance, housing110may be tubular in shape. Housing110, in other embodiments, may be triangular in shape. Of course, other shapes can be used as the present invention is not intended to be limited in this manner.

The delivery mechanism115, as shown inFIG. 1A, can also include a deploying balloon120for use in advancing the sleeve130of device105from within housing110to the site of implantation (e.g., stomach and/or small intestine). The deploying balloon120, in an embodiment, may include an open end122and a closed end124, and may be provided with a length sufficient to accommodate sleeve130. In an embodiment, open end122of deploying balloon120can be provided with a tight fitting seal with the delivery end112of housing110. By providing such a seal at the delivery end112of housing110and by providing the deploying balloon120with closed end124, positive pressure can be introduced into the housing110to evert the deploying balloon120from within the housing110, and to aid in deployment of the sleeve130from the deploying balloon120. Of course, deploying balloon120and housing110can be integral to each other (e.g., as a one-piece design) where additional seal may not be necessary to keep positive pressure in the housing110.

To deploy device105to a site of implantation, deploying balloon120can be made from a material capable of withstanding a sufficient force, so as to permit eversion of the deploying balloon120, and thus advancement of the sleeve130from within the housing110. In an embodiment, the deploying balloon120may be made from a thin-walled membrane. For example, the deploying balloon120may be made from nylon laminated with polyurethane or any similar materials. In an embodiment, the deploying balloon120may have a thickness ranging from about 0.05 mm to about 0.09 mm. In an embodiment, the thickness of the deploying balloon120may be about 0.076 mm or 0.003 inches. The material of the deploying balloon120may also be impermeable to fluids in order to allow the deploying balloon120to withstand sufficient positive pressure. Since the deploying balloon120is designed to be inserted within an intestine of a human or animal body, the deploying balloon120can be made from a material that is biocompatible. The biocompatibility of the material may help minimize occurrence of adverse reactions due to use of the deploying balloon120within an intestine.

As shown inFIGS. 2A-2B, the housing110and the deploying balloon120can be integral with one another (FIG. 2A) or may be provided as two separated components (FIG. 2B). In the embodiment where housing110and deploying balloon120can be integral with one another, housing110and deploying balloon120can be made of the same material, e.g., a continuous sheet of the same sufficiently flexible material. This way, no attachment or connection mechanism is required for connecting housing110and deploying balloon120. Suitable materials include without limitation, plastics, rubber, polymers, resin, cloth, and so on. Alternatively, in the embodiment where housing110and deploying balloon120can be two separate components, housing110and deploying balloon120can be made of different materials. For example, housing110can be made of a sufficiently rigid material, while the deploying balloon120being made of a sufficiently flexible material. Of course, the same material can be used for both the housing110and the deploying balloon120. Suitable attachment or connection mechanism known in the art may also be provided, to the extent desired, so as to connect housing110and deploying balloon120.

As shown inFIG. 2A, the housing110can have a diameter substantially smaller than that of the deploying balloon120. In one example, the diameter of the housing110can be about half of the deploying balloon120while still able to accommodate the deploying balloon120. In other examples (e.g.,FIG. 2B), the housing110can have a diameter that is larger than that of the deploying balloon120. It should be noted thatFIGS. 2A-2Billustrate the deploying balloon120in its everted or deployed position, and that before eversion or deployment, the deploying balloon120can be inverted for placement within the housing110. Of course, the diameter of the housing110and deploying balloon120may remain substantially constant throughout.

It should be appreciated that regardless of the size of the housing110relative to that of the deploying balloon120, the diameter of each should be sufficient to accommodate the sleeve130. It should be appreciated that the length of the housing110should permit the delivery mechanism115to be inserted into an intestine and advanced along the intestine to a site for implantation.

The housing110, in an embodiment, may have any shape desirable, depending on the particular application, as the shape of housing110can facilitate delivery of the device105to a site for implantation. For instance, housing110may be tubular in shape. Of course, other shapes can be used as the present invention is not intended to be limited in this manner.

In accordance with one embodiment, the delivery mechanism115can further include an inflation mechanism (such as inflation device250shown inFIG. 4) for introducing positive pressure into the housing110, so as to cause eversion of the deploying balloon120from within the housing110. Suitable inflation mechanism can include, for instance, an inflation catheter, a pump, or any other inflation device capable of introducing positive pressure the housing110. As the inflation mechanism can be detachably coupled to the housing110, the inflation mechanism can be disconnected and detached from the housing110following inflation. Connection of the inflation mechanism to the housing110may be achieved using any method known in the art.

In order to introduce positive pressure into housing110through the use of an inflatable mechanism, the system100of the present invention may be provided with an inflation port170in the housing110through which fluids (e.g., air, liquids, gas or other substances) can enter with sufficient positive pressure to evert deploying balloon120and subsequently deploy the gastrointestinal implant device105. In one embodiment, inflation port170can be situated at end114of housing110. Of course, other locations for the inflation port170may be possible, as long as fluids can enter with a sufficient force to deploy the device105.

Now referring toFIGS. 3A-3B, the system100of the present invention can be used in connection with a gastroscope160,160′. The gastroscope160,160′ may help guide the system100through the gastrointestinal tract. In an embodiment, the gastroscope160inFIG. 3Amay be provided with a body designed to be situated about or adjacent the housing110. The gastroscope160may also be provided with tip162to be positioned against a surface of the anchoring mechanism140. In such an embodiment, the anchoring mechanism140may be constructed of transparent material to allow visualization out the end of the gastroscope160as shown inFIG. 3A. No X-ray exposure or any other mechanism may be needed to help deploy the gastrointestinal implant device105of the present invention. Should it be desired, delivery mechanism115and device105may include an opaque substance to permit visualization by a user during implantation.

In certain embodiments, the system100of the present invention may be designed to allow a gastroscope160′ to help guide the system100through the intestinal tract. As shown inFIG. 3B, gastroscope160′ may be used with the deploying balloon120′ and sleeve130′ in their everted or deployed position to help guide the sleeve130′ to its desired location (e.g., to further extend along the small intestine). The gastroscope160′, as shown, may be positioned through the housing110and beyond and designed to maintain the stability of the system100as the system100is advanced along the gastrointestinal tract. It should be noted that while the gastroscope160can be positioned in any manner to allow guidance of the system100, its design should minimize any obstructions of the deploying balloon120and sleeve130from everting. In an embodiment, the gastroscope160may be any guidewire that is commercially available.

Looking now atFIGS. 4-6, there are illustrated alternative system of the present invention. As illustrated, system200can be used to provide bariatric therapy. System200, in an embodiment, can include a delivery mechanism215and an implant device205. In accordance with the embodiments shown inFIGS. 4-6, delivery mechanism215may be substantially similar to the delivery mechanism115described above, but the housing110delivery mechanism215may be a reservoir210for use in connection with the deployment of the device205. Such a housing210can allow the delivery mechanism215to reside in different organs, such as the stomach in a patient, in addition to being inserted into the intestine. The delivery mechanism215, in accordance with one embodiment, may include a reservoir210for use in connection with implantation of device205. In one embodiment, the reservoir210may serve substantially the same functions as housing110in that the reservoir210can be used to accommodate at least a part of the device205and deliver the device205to a site for implantation. Reservoir210, if desired, may be designed to accommodate sleeve230in reservoir210and may be designed to facilitate eversion of sleeve230.

In an embodiment, the reservoir210can be made from a material that can be sufficiently strong to allow the reservoir210to be directed within the body of a patient without rupturing. The material, in an embodiment, can also be sufficiently flexible to allow the reservoir210to expand and collapse during deployment of the device205.

The reservoir210may have any shape, as long as the shape can fit within the intestine or esophagus for delivery. In an embodiment, the reservoir210can be substantially circular in shape and can be expanded to any shape desired. In another embodiment, the reservoir210can be tubular in shape. Of course, other shapes are possible. The reservoir210, in another embodiment, may have a size and/or length sufficient to accommodate balloon220and/or sleeve230. As shown inFIG. 5A, the size and/or length of the reservoir210may be such that it may accommodate balloon220and/or sleeve230in a folded or rolled up manner.

The reservoir210may also be provided with any size desirable, as the size the reservoir210may facilitate delivery of device205and sleeve230. For example, a smaller sized reservoir210may be used to deliver device205through an individual's esophagus, while a larger one may not be able to fit through an esophagus.

The delivery mechanism215, in an embodiment, may further include a deploying balloon220, similar to deploying balloon120, for use in placement of the device205at the site of implantation within the gastrointestinal tract. It should be noted that the length and shape of the deploying balloon220should be such that the balloon220can fit (e.g., in a folded or rolled up manner), at least partially within the reservoir210. In an embodiment, the balloon220can be attached to or positioned about an end of the reservoir210at its open end222.

A sleeve230may be stored (e.g., in an inverted state) within deploying balloon220similar to the manner in which the sleeve130can be stored within deploying balloon120and housing110, as described above. In an embodiment, the sleeve230may be stored in a folded state such as shown inFIG. 5Aor may be stored in a rolled up state. Of course, the sleeve230may be stored in other manners so long as it fits, at least partially within the reservoir210. An anchoring mechanism240for anchoring and securing device205to a site of implantation, similar to the one described above, may be situated at the proximal end232of sleeve230, as shown inFIG. 4.

To deploy the gastrointestinal implant device205, an inflation device250may be connected to the reservoir210. The inflation device250, in an embodiment, may be designed so as to permit insertion of the gastrointestinal implant device205through the esophagus of a patient. In an embodiment, the inflation device250can be sufficiently thin and narrow. A seal280, can be provided at the end of the inflation device250, as desired, to minimize leakage of fluid being introduced by inflation device250.

FIGS. 5A,5B, and6show the use of a gastroscope260to help guide the system200through the intestinal tract to a site of interest. The gastroscope260, as shown inFIG. 5A, can be positioned through the inflation device250and the reservoir210. In another embodiment shown inFIG. 6, gastroscope260′ can extend to reservoir210without going through the inflation device250. It should be noted thatFIGS. 5B and 6show the system200′ in a fully deployed state, with the deploying balloon220′ and sleeve230′ in their everted position.

To prepare the system100for insertion in the body, a user can initially position a deploying balloon120within housing110of delivery mechanism115. In one embodiment, the open end122of the deploying balloon120can be situated adjacent or attached to the delivery end112of the housing110, and the closed end124of the deploying balloon120can be situated adjacent the opposing end114of the housing110. An open ended sleeve130may then be placed within cavity126of deploying balloon120with the open ended distal end134of the sleeve130situated adjacent the closed end124of the deploying balloon120, while the proximal end132of the sleeve130situated adjacent the open end122of the deploying balloon120. Additionally, anchoring mechanism140, being coupled to the proximal end132of the sleeve130, can be positioned about the delivery end112of the housing110.

Once loaded, the system100may be inserted into the body, and advanced along the intestine within the body to a site of interest for implantation. A gastroscope160may be used to help guide the system100through the intestinal tract to a site of implantation. In an embodiment, a guidewire (not shown) may be used to maintain the stability of the system100as the system100advances through the tract. Once at the site of implantation, the system100can be prepared for deploying the device105. Implantation may first require the anchoring mechanism140, attached to the proximal end132of the sleeve130, to be inflated using an inflation mechanism. Inflation of the anchoring mechanism140can act to hold the gastrointestinal implant device105in a desired position during the eversion process. For example, the anchoring mechanism140can be placed within the stomach or in the small intestine adjacent the pyloric junction. After the anchoring mechanism140is anchored at the site of interest, the sleeve130may be everted. Eversion may require the direction of pressurized or unpressurized fluid (e.g., gas, liquid, or a combination thereof) into housing110via inflation port170. As fluid is directed into housing110, the fluid acts to evert and advance deploying balloon120from within housing110, while pushing sleeve130from housing110along with deploying balloon120, as shown inFIG. 3B. In some embodiments, the sleeve130is a shorter length than the deploying balloon120, which can allow complete delivery of the sleeve130upon full eversion of deploying balloon120.

FIG. 7-8show the deploying balloon120and sleeve130of the system100in partial eversion and subsequent deployment upon full eversion. InFIG. 7, gastrointestinal implant device105′ is in the process of being everted from within the passageway116of the housing110, where everting deploying balloon120′ pushes and everts the sleeve130′ from therewithin. The everting deploying balloon120′, thereafter, can distend the intestine as it is deploying the everting sleeve130′, and can automatically follow the course of the bowel.FIG. 8shows the implant device105″ in a fully deployed state, with everted deploying balloon120″ extending beyond the everted sleeve130″. With the gastrointestinal implant device105″ deployed and engaged within the intestinal wall, food and other food material can be passed from the stomach through the everted sleeve130″.

In accordance with the embodiments depicted inFIGS. 4-6, the method of deploying device205using a reservoir210may be substantially similar to the method described above with several changes to reflect the use of a reservoir210. Once loaded into the reservoir210, system200may be inserted into the body, and advanced along the intestine within the body to a site of implantation. A gastroscope260may be used to guide the system200through the gastrointestinal tract. Implantation may first require the anchoring mechanism240, attached to the proximal end232of the sleeve230, to be inflated using an inflation mechanism. After the anchoring mechanism240is anchored to the stomach or small intestine at the site of implantation, the device205may be everted. Eversion may require activation of the inflation device250, which can result in the reservoir210being inflated, as shown inFIG. 5A. Inflation of the reservoir210can cause the reservoir210to enlarge and/or become pressurized, allowing the balloon220to evert and deploy the device205.FIGS. 5B and 6show embodiments of the system200in a fully deployed state. In an embodiment, the reservoir210can provide a low friction compartment for everting the balloon220and sleeve230.

Following deployment of the sleeve130, the deploying balloon120can be deflated and a vacuum can be drawn to constrict the deploying balloon120. Constriction of the deploying balloon120can allow the deploying balloon120to be pulled out of the sleeve130, leaving the sleeve130in position within the intestine. Since the diameter of the deploying balloon120can be less than the diameter of the sleeve130, deploying balloon120withdrawal is performed upon deflation and formation of a vacuum in the deploying balloon120. As previously stated, a coating or lubrication may be placed between the sleeve130and the deploying balloon120during manufacture, to ensure easy deploying balloon120removal.

With reference now toFIGS. 9-13, there are illustrated another bariatric therapy system300in accordance with an embodiment of the present invention. System300, in an embodiment, can include a delivery mechanism315and an implant device305. As shown inFIGS. 9-13, the delivery mechanism315may be substantially similar to the delivery mechanism115,215described above, but no separate housing may be necessary to deploy the device305. The delivery mechanism315, in an embodiment, may include a deploying balloon320, similar to deploying balloon120and housing110in the embodiments described above, for use in the placement of device305at the site of implantation within the gastrointestinal tract. It should be noted that the length and shape of the deploying balloon320should be such that the balloon320can fit within the intestinal track. In an embodiment, the deploying balloon320may be formed from a continuous piece of material as shown inFIG. 9A. The deploying balloon320may also be formed from a soft and flexible material such that upon inflation of the balloon320, the pressure therein can allow the device305to be advanced through the intestinal track. The material from which deploying balloon320can be made can also be inelastic to withstand a sufficient pressure for deploying the device305. In an embodiment, the deploying balloon320may be formed from a single thin-walled membrane. For example, the deploying balloon320may be made from nylon laminated with polyurethane. In an embodiment, the deploying balloon320may have a thickness ranging from about 0.05 mm to about 0.09 mm. In an embodiment, the thickness of the deploying balloon320may be about 0.076 mm or 0.003 inches.

Referring still toFIG. 9A, the delivery mechanism315, in an embodiment, may further include a sleeve330that may be positioned within deploying balloon320, similar to the manner in which the sleeve230can be stored within deploying balloon220, as described above. The sleeve330, in one embodiment, may be formed from a membrane that can be less thick than the thickness of the membrane used to form the deploying balloon320. In an example, the sleeve330may be approximately 0.025 mm (0.001″) in thickness. The materials from which sleeve330may be formed includes without limitation, polyethylene, polyvinyl chloride, nylon, polyethylene terephthalate, or other polymer. The relative thickness of the intestinal sleeve330compared to the deploying balloon320can be important, as such thickness can provide less friction during eversion of the sleeve330and the deploying balloon320. In one example, when a sleeve material has a thickness less than the thickness of the balloon material, air eversion may be possible and the everting structure may be sufficiently soft to advance through tortuous bowel. In one embodiment, a sleeve material can have a thickness that is about one-third of the thickness of the balloon material. In other examples, when a sleeve material has a substantially similar thickness to that of the balloon material, friction between the membrane layers may cause inflation pressure to rise to a sufficiently high level, such that an incompressible fluid (water or saline) may be required to deploy the sleeve330. This may, in turn, cause increased rigidity of the everting closed ended balloon320.

The device305may further include an anchoring mechanism340for anchoring and securing device305to a site of implantation. In an embodiment, anchoring mechanism340may be situated at proximal end332of sleeve330. Anchoring mechanism340may be designed to be self-expanding and/or with a minimal profile so that when it is positioned within the stomach, the anchoring mechanism340can allow the stomach to retain substantially its full functional volume. In accordance with the embodiments shown inFIGS. 9-13, the anchoring mechanism340may be a self-expanding anchor or frame, for securing against the stomach wall. The anchoring mechanism340, as shown inFIG. 10, may be a thin structure that can be designed to expand immediately proximal to the pylorus, and remains in the stomach, to allow the intestinal sleeve330to extend into the small intestine (e.g., into the duodenum and jejunum). The proximal end332of sleeve330, in some embodiments, may be situated within the stomach just above the pylorus.

The anchoring mechanism340, in one embodiment, may be constructed of spring metal, such as stainless steel, or it may be formed of a rigid plastic, such as polyurethane or polyethylene or polyethylene terephthalate. The anchoring mechanism340may be processed to have shape memory properties. The anchoring mechanism340may also be designed to present a smaller packing profile, as a thin frame can occupy less space than multiple layers of membrane in an inflatable anchor, and may present less obstruction to outflow of stomach contents.

The system300may also be designed to accommodate a gastroscope360. The gastroscope360may be used to provide or enhance columnal strength for advancement of the device into the duodenum in preparation for deployment of the intestinal sleeve in the bowel. In an embodiment, the gastroscope360can be a part of the system300. The gastroscope360may be constructed from a plastic material such as polyethylene, polyethylene terephthalate, polyvinyl chloride, polyurethane, polytetrafluoroethylene (Teflon), or any other known strong material. In an embodiment, the gastroscope360may contain fiber or wire strands or braid for reinforcement.FIG. 11shows a system300having gastroscope tube380, gastroscope360, anchor340, and inverted deploying balloon320and sleeve330.

The gastroscope360, in an embodiment, may be provided within a gastroscope tube380. The gastroscope360and/or tube380may be coupled to the deploying balloon320, for example, through the use of a coupling mechanism335, so as secure the device305thereto. The deploying balloon320may also be bonded to the gastroscope360and/or tube380to form a compact unit. The bonding, in an embodiment, can be along one line axially. In some embodiments, the gastroscope360and/or tube380may be coupled to the deploying balloon320through the use of an adhesive, such as glue or tape. In other embodiments, the gastroscope tube360and/or380may be coupled to the deploying balloon320through the use of a nail, screw, clip or other coupling mechanism335capable to bonding the gastroscope tube360and/or380to the balloon320. Of course, those skilled in the art may appreciate that other coupling mechanisms335may also be possible as the present invention is not intended to be limited in this manner.

The gastroscope360may also contain a connecting mechanism342, as shown inFIGS. 13A and 13B, for holding the anchoring mechanism340in position during deployment of the intestinal sleeve. The connecting mechanism342may be designed to couple the deploying balloon320to the gastroscope360. In one embodiment, the connecting mechanism342may include a suture343to couple the deploying balloon320to the gastroscope360. An opening in the side of the gastroscope360may be provided to allow the suture343to pass therethrough. As shown inFIG. 13B, the suture343may run the length of the gastroscope360, out the side opening, through a loop in the anchoring mechanism340, and end at a proximal port, to secure the anchoring mechanism340to the gastroscope360. In an embodiment, the suture343may be designed so that it can be severed and removed so as to release the anchoring mechanism340and sleeve330following deployment. In another embodiment, the connecting mechanism342may further be designed to provide reference positioning for intestinal sleeve deployment.

The system300of the present embodiment may further include a sheath310, as shown inFIGS. 12A-12C, designed to for placement over the anchoring mechanism340, the proximal end of deploying balloon320, and the proximal end of the sleeve330. The sheath310may be made from a semi-flexible material with a length sufficient to cover substantially the entire length of the anchoring mechanism340. Of course, the length of sheath310can be varied according to specific designs. In an embodiment, sheath310can be sufficiently long so as to cover substantially the entire length of the deploying balloon320and sleeve330. A wire365may be coupled to the sheath310and may extend substantially along the length of the device305or beyond. The wire365may be designed to be pulled, so as to withdraw the sheath310(prior to deployment of the sleeve330) as illustrated inFIG. 12C, with the anchoring mechanism340in an expanded state.

To deploy the gastrointestinal implant device305, as shown inFIG. 9B, delivery mechanism315of system300may be provided with an inflation port370. In an embodiment, the inflation port370may be designed to allow fluids (e.g., air, liquids, gas or other substances) to enter with sufficient pressure to evert deploying balloon320and deploy the gastrointestinal implant device305. In one embodiment, inflation port370can be coupled to deploying balloon320. Of course, other locations for the inflation port370are possible as long as fluids can enter delivery mechanism315with a sufficient force to deploy the device305.

To prepare the delivery mechanism315for insertion in the body, a user can initially position an open ended sleeve330within deploying balloon320. In an embodiment, the proximal end332of the sleeve330may be situated adjacent the open end322of the deploying balloon320, while the distal end334of the sleeve330may be situated adjacent the closed end324of the deploying balloon320. Additionally, anchoring mechanism340, can be coupled to the proximal end332of the sleeve330. The open ended sleeve330, deploying balloon320and anchoring mechanism340, in one embodiment, may be compressed and encased within sheath310.

Once loaded, the delivery mechanism315may be inserted into the body, and advanced along the intestine within the body to a site of interest for implantation. The gastroscope360may be used to help guide the delivery mechanism315through the intestinal tract to a site of implantation. In an embodiment, a guidewire (not shown) may be used to maintain the stability of the delivery mechanism315, as the delivery mechanism315advances through the tract. Once at the site of implantation, the delivery mechanism315can be prepared for deploying the device305. Deployment may first require removal of the sheath310by pulling wire365to withdraw the sheath310, prior to deployment of the sleeve330, which may act to cause subsequent expansion of the anchoring mechanism340. Expansion of the anchoring mechanism340can act to hold the gastrointestinal implant device305in a desired position during the eversion process. After the anchoring mechanism340is anchored to the stomach wall or intestinal wall at the site of interest, the sleeve330may be everted from within the deploying balloon320. Eversion may require activation of the inflation port350, which can result in the deploying balloon320being inflated. Inflation of the deploying balloon320can cause the deploying balloon320to enlarge and/or become pressurized, allowing the deploying balloon320to evert and deploy the device305. In an embodiment, the deploying balloon320can provide a low friction compartment for everting the sleeve330. With the gastrointestinal implant device305deployed and engaged within the intestinal wall, food and other food material can be passed through the sleeve330.

Following deployment of the sleeve330, the gastroscope360, deploying balloon320and sheath310can be removed from the body. For example, the suture343may be severed and removed so as to release the anchoring mechanism340and sleeve330following deployment. In an embodiment, the deploying balloon320may be constricted to allow the deploying balloon320to be pulled out of the sleeve330, leaving the sleeve330in position within the intestine. Since the diameter of the deploying balloon320can be less than the diameter of the sleeve330, deploying balloon320withdrawal may be performed upon deflation and formation of a vacuum in the deploying balloon320. As previously stated, a coating or layer of lubrication may be placed between the sleeve330and the deploying balloon320during manufacture, to ensure easy deploying balloon320removal.

Turning now toFIG. 14, there is illustrated an expandable body400for use, for example, as an anchor in connection with the gastrointestinal implant devices of the present invention. In an embodiment, expandable body400can be used to secure placement of the sleeve in the gastrointestinal tract (e.g., from within the stomach, the duodenum, adjacent the pylorus, or within the small intestine). Expandable body400may include a geometric array of struts that may form a three-dimensional structure, such as a geodesic sphere, a system of interconnected loops or hoops410, an ellipsoid structure, or other elastic forms that may define a three-dimensional structure.

Expandable body400, in an embodiment, may be constructed from any suitable elastic or shape-memory materials described herein, such as spring metal (e.g., stainless steel) and/or spring plastic (e.g., polyurethane, polyethylene, or polyethylene terephthalate). The materials used, in an embodiment, should provide sufficient elasticity may be provided by such materials, such that expandable body400may collapse, for instance, by compression and expand, for instance, after deployment as desired.

Expandable body400, in an embodiment, may also include one or more expandable mechanism (not shown). For example, expandable body400may be an expandable array of struts or loops that form an elastic structure which, upon expansion, may occupy a greater degree of volume to provide a space occupying effect. Such space occupying effect in the stomach may act to reduce the functional volume of the stomach and/or provide a feeling of satiety. In another embodiment, expandable body400may also be a metal or plastic frame (e.g., formed by struts410) with one or more secondary expandable structures attached thereto. In some instance, the expandable mechanism may be inflatable.

Expandable body400may contain at least two openings420, through which undigested, partially digested, or completely digested food can be directed from the stomach into the intestinal sleeve, such as sleeve130shown inFIG. 1B. In particular, one opening may be sufficiently large and in alignment with the entrance, such as the proximal end of the intestinal sleeve, so as to hold the intestinal sleeve open to allow entry of food.

In certain embodiments, expandable body400may be provided with sufficient elasticity. This may be advantageous for use as an anchoring mechanism in the stomach. Without wishing to be bound by any theory, advantages of a sufficiently elastic expandable body400for use in the stomach may be explained as follows: The stomach undergoes contraction and peristalsis, as it moves food out into the duodenum. A sufficiently elastic expandable body400placed inside the stomach may contract and expand as the stomach contracts and relaxes. This way, expandable body400may be prevented from being expelled out of the stomach as may occur to a substantially rigid anchor.

Expandable body400may be configured with a diameter as large as needed to achieve anchoring, for example, from approximately 6 cm to 12 cm or greater. Both the elasticity and geometric structure, as described, may help anchor expandable body400within the stomach, and prevent it from being expelled by the stomach. As such, while stomach peristalsis tends to move food towards the pylorus, and expandable body400tends to move down to the antrum, an intestinal sleeve that is coupled to expandable body400may remain anchored in the desired position (e.g., within the antrum). The anchoring effect of the elastic expandable body400to stay within the stomach may be analogized to the physiologic mechanism of a gas embolus in the arterial system: Gas is compressible, and a volume of gas residing in an artery while compressing and expanding along with the arterial pulse, does not significantly move down the artery.

In addition to the anchoring and space occupying potential of expandable body400described above, expandable body400may also be designed to expand in circle to contact the stomach wall, distend the stomach, and/or act to provide a feeling of satiety to the patient implanted with such a framework. In an embodiment, stomach distention may result in neural feedback of fullness, adding to the therapeutic bariatric effects of the implant device, which may include volume restriction or reduction by the anchoring mechanism and nutrient malabsorption by the intestinal sleeve.

With reference now toFIGS. 15-16, there is illustrated a gastrointestinal implant device500having two anchoring mechanisms510and520. A first anchoring mechanism510may be designed for secure placement within the stomach, as discussed above. A second anchoring mechanism520may be coupled to and spaced from the first anchoring mechanism510. The second anchoring mechanism520may be designed to be secured within a gastrointestinal tract and outside the stomach. In an embodiment, the second anchoring mechanism520may be placed within the duodenum just past the pylorus, or anywhere in the small intestine. It should be noted that the spacing between the two anchoring mechanisms510and520may be chosen according to their desired placement in the gastrointestinal tract. In an embodiment, sufficient spacing may be provided to allow lateral movement and/or axial rotation, such that relative movement between the two anchoring mechanisms510and520can be accommodated.

As illustrated inFIGS. 15A-15C, the first anchoring mechanism510may or may not be coupled to sleeve530, while the second anchoring mechanism520may be coupled to and at least partially positioned within sleeve530. That is, sleeve530may be circumferentially situated and attached on an outer surface of the second anchoring mechanism520to partially or substantially completely cover the second anchoring mechanism520. In certain embodiments, sleeve530may extend from the second anchoring mechanism520into the small intestine, after eversion and deployment. Sleeve530may also be expanded outwardly by the second anchoring mechanism520to provide a passageway540therethrough. In addition, sleeve530may be anchored by the second anchoring mechanism520against retrograde movement that may be caused by a back force, for example, during patient vomiting.

It should be noted thatFIGS. 15A-15Cshow sectional views of gastrointestinal implant device500, with the first and second anchoring mechanisms510and520being shown as disk-like structures, for illustration purposes only. While the corresponding three-dimensional view may be substantially spherical, the first and second anchoring mechanisms510and520may independently have any other suitable geometry such as a geodesic sphere, a truncated icosahedron, an ellipsoid structure, or a half or partial structure thereof.

In certain embodiments, the second anchoring mechanism520may have a smaller diameter than the first anchoring mechanism510, so as to fit within the duodenum or along other parts in the small intestine. The second anchoring mechanism520may also have a substantially similar or larger diameter than the first anchoring mechanism510, depending on the relative anatomical size of the duodenum, small intestine, and stomach of the patient requiring the implant. Regardless of their relative size, anchoring mechanisms510and520may expand outwardly against the stomach, duodenum, or small intestine, without significantly overstretching the respective tissue.

The first and second anchoring mechanisms510and520, in an embodiment, may be connected to each other via any suitable coupling mechanisms known in the art. Exemplary coupling mechanisms include, without limitation, threading, tethering, and tying. Suitable coupling mechanisms may be connected to anchoring mechanisms via methods known in the art such as gluing, bonding, interlocking, fastening, molding, welding, clamping, etc.

For example, the first and second anchoring mechanisms510and520may be connected by a portion535of the sleeve530, as shown inFIG. 15A. In an embodiment, sleeve portion535between anchoring mechanisms510and520may be sufficiently inelastic, so as to minimize sleeve portion535from twisting. Such inelasticity may also help hold anchoring mechanisms510and520in a substantially fixed relative position. In some cases, sleeve portion535and anchoring mechanisms510,520may be molded or formed as a one-piece design. To the extent desired, sleeve portion535(or a portion thereof) may have a diameter that fits in the pylorus in its closed position. Alternatively, sleeve portion535may be substantially elastic while holding anchoring mechanisms510and520in a substantially fixed relative position (e.g., at either side of the pylorus). For example, a substantially elastic sleeve portion535may be in a stretched state which may exert a contracting or pulling force to anchoring mechanisms510and520toward one another. This way, a compressive force may be exerted on the pylorus by anchoring mechanisms510and520, thereby increasing the anchoring function of the implant device500, with minimal relative movement of anchoring mechanisms510,520and sleeve530. It should be noted that while sleeve portion535may have various degree of elasticity depending on the specific device design, it should be sufficiently flexible to bend or move according to the patient's body movement. In addition, such flexibility of sleeve portion535and/or other portions of sleeve530may be desirable, for example, to allow the portion extending distally from the second anchoring mechanism520to move between an inverted position and an everted position.

In the embodiments illustrated inFIGS. 15B and 15C, the first and second anchoring mechanisms510and520may be connected by one or more tethering mechanism550or560. In this case, sleeve530is attached to the second anchoring mechanism520only. As discussed above, the second anchoring mechanism520may be designed to expand to contact the inner wall of the duodenum, or other parts of the small intestine. This design may help seal sleeve530against the duodenal or intestinal wall to ensure that food exiting the stomach passes into sleeve530, without leaking into the small intestine. Such a design may also help securely anchor sleeve530at its point of contact with the duodenal or intestinal wall.

Where the second anchoring mechanism520is connected to the first anchoring mechanism510by multiple tethering mechanisms550, as shown inFIG. 15B, the multiple tethering mechanisms550may be configured in such a way that they do not substantially interfere with the opening or closing of the pylorus as it occurs in accordance with the digestive process. For example, the multiple tethering mechanisms550may attach, at either end, adjacent the respective central axis of anchoring mechanisms510and520, such that the multiple tethering mechanisms550may be arranged in proximity to one another. In addition, spacing between adjacent tethering mechanisms should be designed in a way such that even upon twisting of the multiple tethering mechanisms550, food passageway between anchoring mechanisms510and520is neither blocked nor occluded. That is, food should still be able to pass through the spaces between adjacent tethering mechanisms to enter sleeve530.

A single tethering mechanism560may also be used, as shown inFIG. 15C. This design may be preferred, in some embodiments, allowing more space for the passageway between anchoring mechanisms510and520.

Tethering mechanisms550,560may be made from any suitable structure or material known in the art. In an embodiment, tethering mechanisms550,560may be a connecting cords, wires, strings, cables, rods, ropes, and the like. The diameter of tethering mechanisms550,560may be sufficiently small so as to not substantially occlude the passageway between anchoring mechanisms510and520when food passes therethrough. The length of tethering mechanisms550,560may also be chosen (e.g., a few centimeters or longer) such that different anatomical pyloric lengths may be accommodated by one or few versions of implant device500. Alternatively, the length of tethering mechanisms550,560may be custom made for the patient.

Tethering mechanisms550,560may have sufficient flexibility to bend or move along with movement of the patient's body. In an embodiment, tethering mechanisms550,560may be made of spring metal or plastic. In some embodiments, tethering mechanisms550,560may be sufficiently elastic while holding anchoring mechanisms510and520in a substantially fixed relative position at either side of the pylorus. As discussed above, such design may impart a compressive force on the pylorus to enhance anchoring of the anchoring mechanisms510and520adjacent the pylorus. Tethering mechanisms550,560, in another embodiment, may be substantially inelastic, such that no significant compression is exerted on the pylorus. When substantially inelastic tethering mechanism(s) are used, a limited degree of movement may be experienced by the implant device500relative to the pylorus, to the extent that the respective anchoring mechanism510or520contacts either side of the pylorus.

To the extent desired, anchoring mechanisms510,520and the tethering mechanism(s) therebetween may be molded or formed as a one-piece design. Alternatively, these parts can be formed separately and then attached together. Various suitable attaching/connecting methods known in the art can be used to attach the tethering mechanism and the anchoring mechanism. For instance, suitable methods include glue, key-lock structures or the like, sucking disks, clamps, hooks, screws, latches, and so on.

Other suitable tethering mechanisms for connecting anchoring mechanisms510and520may also be used. For example, an expandable metal or plastic frame (e.g., having shape memory property) may be used, which may expand or collapse along with the opening or closing movement of the pylorus. Upon expansion, a passageway may extend between anchoring mechanisms510and520to allow food to pass through and enter sleeve530.

FIG. 16Aillustrates a perspective view of a gastrointestinal implant device500having two anchoring mechanisms510and520. In an embodiment, anchoring mechanisms510and520may each include a plurality of struts515to form a framework. One or more of struts515may be expandable, as discussed above. Multiple tethering mechanisms550may be provided to connect anchoring mechanisms510and520.FIGS. 16B and 16Care side views of anchoring mechanisms510,520and tethering mechanisms550therebetween,FIG. 16Cbeing turned 90 degrees relative toFIG. 16B.

In addition to the structural configurations for the anchoring mechanisms discussed above, any suitable shapes that offer sufficiently small strut profile, desired structural integrity, and sufficient spacing between struts for food passage may also be used. By way of example, suitable shapes include spherical or non-spherical truncated icosahedrons as shown inFIGS. 17A and 17B, geodesic spheres as shown inFIGS. 17C and 17D, and full or partial spheres as shown inFIG. 17E.

With reference now toFIGS. 18-19, there is illustrated another two-anchor device505for use in connection with an intestinal sleeve (not shown) to form a gastrointestinal implant device, as discussed herein. In an embodiment, the two anchoring mechanisms510and520may be partial spheres (FIG. 18) or partial geodesic spheres (FIG. 19). Anchoring mechanisms510and520have substantially the same diameter as illustrated, or different diameters in accordance with the relative anatomical size of the stomach and duodenum.

Anchoring mechanisms510and520may each include a plurality of interconnected members515such as loops (FIG. 18) or struts (FIG. 19). Both anchoring mechanisms510and520, in an embodiment, may be constructed from suitable expandable materials described herein, such as spring metal (e.g., stainless steel) and/or spring plastic (e.g., polyurethane, polyethylene, or polyethylene terephthalate). As discussed above, one or more of the interconnected members515may be expandable. For example, the first anchoring mechanism510may be provided with one or more expandable mechanism which, upon inflation, may occupy a greater degree of volume to reduce the functional volume of the stomach. Such inflated mechanism may also exert an additional pressure to the stomach wall, enhancing the secured placement of the first anchoring mechanism510within the stomach. Similarly, the second anchoring mechanism520may also include one or more expandable mechanism which, upon inflation, may exert a radial force against the duodenal wall, for securing the second anchoring mechanism520within the duodenum. It should also be appreciated that where sleeve530is attached to the outer surface of the second anchoring mechanism520, such radial force may also act to secure and anchor sleeve530against the duodenal wall.

A single tethering mechanism560may be provided between anchoring mechanisms510and520to connect them. More than one tethering mechanisms may also be used, as discussed above. For ease of construction, tethering mechanism560may be molded as one piece together with anchoring mechanisms510and520(e.g., as a metal or plastic structure). Alternatively, these parts can be formed separately and then assembled into the two-anchor device505. In this case, tethering mechanism560may be connected at either end to anchoring mechanisms510and520by designs562and564shown inFIG. 18. Other suitable designs or connecting mechanisms known in the art may also be used. For example, tethering mechanism560may be mounted on, bonded to, glued to, molded with, assembled into, or interlocked with anchoring mechanisms510and520.

In a preferred embodiment,FIGS. 19A-19Cillustrate a two-anchor device505in side view (FIG. 19A), perspective view (FIG. 19B), and top view (FIG. 19C). In an example, the major diameter (a) and height (b) of anchoring mechanisms510,520, as well as the length (c) of tethering mechanism560, may be chosen according to average anatomical size of the gastrointestinal system. Alternatively, these measurements may be custom made for each patient or patient group.

In operation, the first and second anchoring mechanism510and520may first be secured along a gastrointestinal tract of a patient. For example, the first anchoring mechanism510may be secured within a stomach, and the second anchoring mechanism520may be secured beyond the stomach, such as in a duodenum. Next, sleeve530may be placed about an outer surface of the second anchoring mechanism520and extend therefrom into a small intestine. In an embodiment, sleeve530may be situated circumferentially about the outer surface of the second anchoring mechanism520. The second anchoring mechanism520may also expand and act to seal sleeve530against the wall of the duodenum. This way, food can be directed through first anchoring mechanism510, second anchoring mechanism520, and sleeve530, sequentially, without leaking into the small intestine.

While the invention has been described in connection with the specific embodiments thereof, it will be understood that it is capable of further modification. For instance, it should be appreciated that any of the anchors or anchoring mechanisms described above may be modified, for use in connection with gastrointestinal implant devices and/or intestinal sleeve delivery systems described herein. Furthermore, this application is intended to cover any variations, uses, or adaptations of the invention, including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains, and as fall within the scope of the appended claims.