Patent Application
20110213469
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.
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.
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 to
As illustrated, the sleeve 130 may include a proximal end 132 that may be designed for placement adjacent the pyloric junction, an area around the pylorus where the stomach and the small intestine meet. The sleeve 130 may further include a passageway 136 extending from the proximal end 132 to allow passage of food and other food material through sleeve 130. As used herein, “food” or “other food material” can be used interchangeably; “food” can also include undigested, partially digested, and completely digested food. The sleeve 130 may further include a distal end 134. The distal end 134, in an embodiment, can be open-ended to provide an opening through which food and other food material can exit sleeve 130.
The sleeve 130, in an embodiment, can be designed to reduce absorption and digestion of food by the intestinal walls. In particular, sleeve 130 can 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 end 134 of sleeve 130. 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 sleeve 130 can be made from any material that can aid in the passage of food through the sleeve 130. In one embodiment, the sleeve 130 can 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 sleeve 130 can be made from a material that is substantially smooth and/or has a relatively low coefficient of friction. The sleeve 130 material may further have substantially low permeability to fluids to minimize the occurrence of digested food leaking through the sleeve 130 and coming into contact with the intestinal wall where it can be absorbed. The sleeve 130 can 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 sleeve 130, once removal is desired. Since the sleeve 130 can be designed to be implanted within an intestine of a human or animal body, the sleeve 130 should 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 sleeve 130 with the gastrointestinal tract. In an embodiment, the sleeve 130 can be made from any material that can be obtained commercially.
Should it be desired, sleeve 130 may 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 sleeve 130. The coating may be applied to the sleeve 130 on an inner surface, an outer surface, or a combination thereof to minimize any porous characteristics of the sleeve material.
In one embodiment, the sleeve 130 can also be made from any material that allows the sleeve 130 to expand and collapse in accordance with the digestive process. When food enters and passes through the sleeve 130, the sleeve material can be such that it may allow the sleeve 130 to expand sufficiently to accommodate the digested food. Once the food from the stomach has passed through the sleeve 130, however, the sleeve material can be such that is may allow the sleeve 130 to become flexible or floppy, permitting the sleeve 130 to contour toward one side of the intestine. In this floppy state, the sleeve 130 may 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 sleeve 130 to maintain a substantially constant form throughout the digestive process. In these instances, the sleeve 130 may be made from a material that can maintain such a substantially constant form.
The length of the sleeve 130 may, in an embodiment, vary depending on a variety of characteristics. In certain instances, the length of the sleeve 130 may be dependent on the patient's Body Mass Index (BMI). In other instances, the length of the sleeve 130 may be selected based on the amount of absorption desired. A longer sleeve 130, for example, may minimize absorption of nutrients by the intestinal walls over a longer distance than a shorter sleeve 130. In some instances, the length of the sleeve 130 may be selected based on the distance necessary to bypass the duodenum and allow the sleeve 130 to couple with the jejunum. It should be noted that the length of the sleeve 130 should also permit the sleeve 130 to fit within the delivery mechanism 115 as well as within the intestine.
The sleeve 130 may have any shape desirable, so long as the shape allows the sleeve 130 to fit within the intestine. In one embodiment, the sleeve 130 may have a substantially tubular shape to allow the sleeve 130 to substantially conform to the intestine. Of course, other geometric shapes may be possible.
The sleeve 130 may further have any diameter desirable so long as the diameter allows food to travel through the sleeve 130 without substantial hindrance. In one embodiment, the sleeve 130 may have a diameter to allow the sleeve 130 to substantially conform to the intestinal walls when in an expanded state. By substantially conforming to the intestinal walls in an expanded state, the sleeve 130 can maximize the amount of food traveling through. Of course, smaller diameters may also be possible.
The gastrointestinal implant device 105 may further include, in accordance with an embodiment of the present invention, an anchoring mechanism 140, coupled to the proximal end 132 of the sleeve 130. The anchoring mechanism 140 may be designed to be positioned, in certain instances, in the stomach to anchor the device 105 thereat. In an embodiment, the anchoring mechanism 140 can be an anchor that acts to reduce the functional volume of the stomach. An example of such an anchoring mechanism 140 can be a space occupying inflatable ring or balloon, or any other anchoring mechanism 140 adapted to adequately engage and secure the proximal end 132 of the sleeve 130 at the pyloric junction, while reducing the volume of the stomach. In an embodiment, the anchoring mechanism 140 can be integral with the sleeve 130 at the proximal end 132, so that the anchoring mechanism 140 and sleeve 130 are formed from one piece of material. Alternatively, the anchoring mechanism 140 can be separate and independent from the sleeve so that the anchoring mechanism and sleeve 130 are formed from two pieces of material and are coupled to one another.
As noted, the anchoring mechanism 140 can be designed, in certain instances, to facilitate weight loss by reducing the functional volume of the stomach 145. In other words, by occupying a portion of the stomach 145, the anchoring mechanism 140 can act to decrease the functional volume of the stomach 145, and thus, the amount of food intake by the patient. To that end, The anchoring mechanism 140, in an embodiment, may have any size desirable, depending on the particular application, as the size of the anchoring mechanism 140 may affect the functional volume by which the stomach 145 is reduced. For instance, a larger anchoring mechanism 140 may 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 mechanism 140 needs to permit the anchoring mechanism 140 to be securely positioned within the stomach at a site of implantation. That is, the anchoring mechanism 140 can be sufficiently large to prevent it from entry into the small intestine.
The anchoring mechanism 140, as illustrated in
To adequately secure the anchoring mechanism 140 within the stomach, the anchoring mechanism 140 can be made from a material that can radially expand to exert a sufficient radial force to push the anchoring mechanism 140 against the walls of the stomach at the site of implantation. It should be appreciated that the material used should permit the anchoring mechanism 140 to 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 mechanism 140 to prevent inflammation or any other adverse reaction caused by the engagement of the anchoring mechanism 140 within the stomach.
In accordance with one embodiment, as illustrated in
An inflation mechanism (not shown) for inflating the anchoring mechanism 140 can include, for instance, an inflation catheter or any other inflation device capable of inflating the anchoring mechanism 140. As the inflation mechanism can be detachably coupled to port or valve 142 of the anchoring mechanism 140, the inflation mechanism can be disconnected and detached from the port or valve 142 of anchoring mechanism 140 following inflation. It should be appreciated that the anchoring mechanism 140 can be deflated when removal of the device 105 is desired.
Connection of the inflation mechanism to port or valve 142 of the anchoring mechanism 140 may occur, in certain embodiments, through the use of a connector (not shown). The connector can act to couple the inflation mechanism to the anchoring mechanism 140 allowing the inflation mechanism to inflate the anchoring mechanism 140. In an embodiment, the connector may be situated on either the inflation mechanism or the anchoring mechanism 140. Alternatively, the connector may include a two-piece design having two complimentary pieces to permit coupling between the inflation mechanism and the anchoring mechanism 140. 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 mechanism 140 can be self-expanding to allow expansion of anchoring mechanism 140 without the aid of additional inflation mechanisms. Such self-expanding mechanism, similar to a life vest, are known in the art.
Still referring to
In one embodiment, the housing 110 can be made from any material capable of passing through the intestine and delivering device 105 to a site of implantation. To that end, housing 110 may be formed from a substantially hard material, so as to minimize deformation of the housing 110 during delivery. Examples of materials that are substantially hard include metals, plastics, ceramics, or any other materials that can maintain a substantially consistent shape. Housing 110 can also be made from a sufficiently flexible material to permit compression of the housing 110. For example, housing 110 may be formed from a thin-walled membrane such as nylon laminated with polyurethane.
Since the housing 110 is designed to be inserted into an intestine of a human or animal body, the housing 110, 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 housing 110 within an intestine. The housing 110 may further include a coating on an outer surface to reduce friction between the housing 110 and the intestinal wall upon insertion into the intestine. Likewise, the housing 110 may include a coating on an inner surface to reduce friction during deployment of the sleeve 130 situated within the housing 110.
It should be appreciated that the housing 110 may be provided with any shape desirable, depending on the particular application, as the shape of the housing 110 may affect ability of the housing 110 to deliver the device 105 to a site for implantation. For instance, housing 110 may be tubular in shape. Housing 110, 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 mechanism 115, as shown in
To deploy device 105 to a site of implantation, deploying balloon 120 can be made from a material capable of withstanding a sufficient force, so as to permit eversion of the deploying balloon 120, and thus advancement of the sleeve 130 from within the housing 110. In an embodiment, the deploying balloon 120 may be made from a thin-walled membrane. For example, the deploying balloon 120 may be made from nylon laminated with polyurethane or any similar materials. In an embodiment, the deploying balloon 120 may have a thickness ranging from about 0.05 mm to about 0.09 mm. In an embodiment, the thickness of the deploying balloon 120 may be about 0.076 mm or 0.003 inches. The material of the deploying balloon 120 may also be impermeable to fluids in order to allow the deploying balloon 120 to withstand sufficient positive pressure. Since the deploying balloon 120 is designed to be inserted within an intestine of a human or animal body, the deploying balloon 120 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 deploying balloon 120 within an intestine.
As shown in
As shown in
It should be appreciated that regardless of the size of the housing 110 relative to that of the deploying balloon 120, the diameter of each should be sufficient to accommodate the sleeve 130. It should be appreciated that the length of the housing 110 should permit the delivery mechanism 115 to be inserted into an intestine and advanced along the intestine to a site for implantation.
The housing 110, in an embodiment, may have any shape desirable, depending on the particular application, as the shape of housing 110 can facilitate delivery of the device 105 to a site for implantation. For instance, housing 110 may 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 mechanism 115 can further include an inflation mechanism (such as inflation device 250 shown in
In order to introduce positive pressure into housing 110 through the use of an inflatable mechanism, the system 100 of the present invention may be provided with an inflation port 170 in the housing 110 through which fluids (e.g., air, liquids, gas or other substances) can enter with sufficient positive pressure to evert deploying balloon 120 and subsequently deploy the gastrointestinal implant device 105. In one embodiment, inflation port 170 can be situated at end 114 of housing 110. Of course, other locations for the inflation port 170 may be possible, as long as fluids can enter with a sufficient force to deploy the device 105.
Now referring to
In certain embodiments, the system 100 of the present invention may be designed to allow a gastroscope 160′ to help guide the system 100 through the intestinal tract. As shown in
Looking now at
In an embodiment, the reservoir 210 can be made from a material that can be sufficiently strong to allow the reservoir 210 to be directed within the body of a patient without rupturing. The material, in an embodiment, can also be sufficiently flexible to allow the reservoir 210 to expand and collapse during deployment of the device 205.
The reservoir 210 may have any shape, as long as the shape can fit within the intestine or esophagus for delivery. In an embodiment, the reservoir 210 can be substantially circular in shape and can be expanded to any shape desired. In another embodiment, the reservoir 210 can be tubular in shape. Of course, other shapes are possible. The reservoir 210, in another embodiment, may have a size and/or length sufficient to accommodate balloon 220 and/or sleeve 230. As shown in
The reservoir 210 may also be provided with any size desirable, as the size the reservoir 210 may facilitate delivery of device 205 and sleeve 230. For example, a smaller sized reservoir 210 may be used to deliver device 205 through an individual's esophagus, while a larger one may not be able to fit through an esophagus.
The delivery mechanism 215, in an embodiment, may further include a deploying balloon 220, similar to deploying balloon 120, for use in placement of the device 205 at the site of implantation within the gastrointestinal tract. It should be noted that the length and shape of the deploying balloon 220 should be such that the balloon 220 can fit (e.g., in a folded or rolled up manner), at least partially within the reservoir 210. In an embodiment, the balloon 220 can be attached to or positioned about an end of the reservoir 210 at its open end 222.
A sleeve 230 may be stored (e.g., in an inverted state) within deploying balloon 220 similar to the manner in which the sleeve 130 can be stored within deploying balloon 120 and housing 110, as described above. In an embodiment, the sleeve 230 may be stored in a folded state such as shown in
To deploy the gastrointestinal implant device 205, an inflation device 250 may be connected to the reservoir 210. The inflation device 250, in an embodiment, may be designed so as to permit insertion of the gastrointestinal implant device 205 through the esophagus of a patient. In an embodiment, the inflation device 250 can be sufficiently thin and narrow. A seal 280, can be provided at the end of the inflation device 250, as desired, to minimize leakage of fluid being introduced by inflation device 250.
To prepare the system 100 for insertion in the body, a user can initially position a deploying balloon 120 within housing 110 of delivery mechanism 115. In one embodiment, the open end 122 of the deploying balloon 120 can be situated adjacent or attached to the delivery end 112 of the housing 110, and the closed end 124 of the deploying balloon 120 can be situated adjacent the opposing end 114 of the housing 110. An open ended sleeve 130 may then be placed within cavity 126 of deploying balloon 120 with the open ended distal end 134 of the sleeve 130 situated adjacent the closed end 124 of the deploying balloon 120, while the proximal end 132 of the sleeve 130 situated adjacent the open end 122 of the deploying balloon 120. Additionally, anchoring mechanism 140, being coupled to the proximal end 132 of the sleeve 130, can be positioned about the delivery end 112 of the housing 110.
Once loaded, the system 100 may be inserted into the body, and advanced along the intestine within the body to a site of interest for implantation. A gastroscope 160 may be used to help guide the system 100 through the intestinal tract to a site of implantation. In an embodiment, a guidewire (not shown) may be used to maintain the stability of the system 100 as the system 100 advances through the tract. Once at the site of implantation, the system 100 can be prepared for deploying the device 105. Implantation may first require the anchoring mechanism 140, attached to the proximal end 132 of the sleeve 130, to be inflated using an inflation mechanism. Inflation of the anchoring mechanism 140 can act to hold the gastrointestinal implant device 105 in a desired position during the eversion process. For example, the anchoring mechanism 140 can be placed within the stomach or in the small intestine adjacent the pyloric junction. After the anchoring mechanism 140 is anchored at the site of interest, the sleeve 130 may be everted. Eversion may require the direction of pressurized or unpressurized fluid (e.g., gas, liquid, or a combination thereof) into housing 110 via inflation port 170. As fluid is directed into housing 110, the fluid acts to evert and advance deploying balloon 120 from within housing 110, while pushing sleeve 130 from housing 110 along with deploying balloon 120, as shown in
In accordance with the embodiments depicted in
Following deployment of the sleeve 130, the deploying balloon 120 can be deflated and a vacuum can be drawn to constrict the deploying balloon 120. Constriction of the deploying balloon 120 can allow the deploying balloon 120 to be pulled out of the sleeve 130, leaving the sleeve 130 in position within the intestine. Since the diameter of the deploying balloon 120 can be less than the diameter of the sleeve 130, deploying balloon 120 withdrawal is performed upon deflation and formation of a vacuum in the deploying balloon 120. As previously stated, a coating or lubrication may be placed between the sleeve 130 and the deploying balloon 120 during manufacture, to ensure easy deploying balloon 120 removal.
With reference now to
Referring still to
The device 305 may further include an anchoring mechanism 340 for anchoring and securing device 305 to a site of implantation. In an embodiment, anchoring mechanism 340 may be situated at proximal end 332 of sleeve 330. Anchoring mechanism 340 may be designed to be self-expanding and/or with a minimal profile so that when it is positioned within the stomach, the anchoring mechanism 340 can allow the stomach to retain substantially its full functional volume. In accordance with the embodiments shown in
The anchoring mechanism 340, 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 mechanism 340 may be processed to have shape memory properties. The anchoring mechanism 340 may 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 system 300 may also be designed to accommodate a gastroscope 360. The gastroscope 360 may 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 gastroscope 360 can be a part of the system 300. The gastroscope 360 may 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 gastroscope 360 may contain fiber or wire strands or braid for reinforcement.
The gastroscope 360, in an embodiment, may be provided within a gastroscope tube 380. The gastroscope 360 and/or tube 380 may be coupled to the deploying balloon 320, for example, through the use of a coupling mechanism 335, so as secure the device 305 thereto. The deploying balloon 320 may also be bonded to the gastroscope 360 and/or tube 380 to form a compact unit. The bonding, in an embodiment, can be along one line axially. In some embodiments, the gastroscope 360 and/or tube 380 may be coupled to the deploying balloon 320 through the use of an adhesive, such as glue or tape. In other embodiments, the gastroscope tube 360 and/or 380 may be coupled to the deploying balloon 320 through the use of a nail, screw, clip or other coupling mechanism 335 capable to bonding the gastroscope tube 360 and/or 380 to the balloon 320. Of course, those skilled in the art may appreciate that other coupling mechanisms 335 may also be possible as the present invention is not intended to be limited in this manner.
The gastroscope 360 may also contain a connecting mechanism 342, as shown in
The system 300 of the present embodiment may further include a sheath 310, as shown in
To deploy the gastrointestinal implant device 305, as shown in
To prepare the delivery mechanism 315 for insertion in the body, a user can initially position an open ended sleeve 330 within deploying balloon 320. In an embodiment, the proximal end 332 of the sleeve 330 may be situated adjacent the open end 322 of the deploying balloon 320, while the distal end 334 of the sleeve 330 may be situated adjacent the closed end 324 of the deploying balloon 320. Additionally, anchoring mechanism 340, can be coupled to the proximal end 332 of the sleeve 330. The open ended sleeve 330, deploying balloon 320 and anchoring mechanism 340, in one embodiment, may be compressed and encased within sheath 310.
Once loaded, the delivery mechanism 315 may be inserted into the body, and advanced along the intestine within the body to a site of interest for implantation. The gastroscope 360 may be used to help guide the delivery mechanism 315 through 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 mechanism 315, as the delivery mechanism 315 advances through the tract. Once at the site of implantation, the delivery mechanism 315 can be prepared for deploying the device 305. Deployment may first require removal of the sheath 310 by pulling wire 365 to withdraw the sheath 310, prior to deployment of the sleeve 330, which may act to cause subsequent expansion of the anchoring mechanism 340. Expansion of the anchoring mechanism 340 can act to hold the gastrointestinal implant device 305 in a desired position during the eversion process. After the anchoring mechanism 340 is anchored to the stomach wall or intestinal wall at the site of interest, the sleeve 330 may be everted from within the deploying balloon 320. Eversion may require activation of the inflation port 350, which can result in the deploying balloon 320 being inflated. Inflation of the deploying balloon 320 can cause the deploying balloon 320 to enlarge and/or become pressurized, allowing the deploying balloon 320 to evert and deploy the device 305. In an embodiment, the deploying balloon 320 can provide a low friction compartment for everting the sleeve 330. With the gastrointestinal implant device 305 deployed and engaged within the intestinal wall, food and other food material can be passed through the sleeve 330.
Following deployment of the sleeve 330, the gastroscope 360, deploying balloon 320 and sheath 310 can be removed from the body. For example, the suture 343 may be severed and removed so as to release the anchoring mechanism 340 and sleeve 330 following deployment. In an embodiment, the deploying balloon 320 may be constricted to allow the deploying balloon 320 to be pulled out of the sleeve 330, leaving the sleeve 330 in position within the intestine. Since the diameter of the deploying balloon 320 can be less than the diameter of the sleeve 330, deploying balloon 320 withdrawal may be performed upon deflation and formation of a vacuum in the deploying balloon 320. As previously stated, a coating or layer of lubrication may be placed between the sleeve 330 and the deploying balloon 320 during manufacture, to ensure easy deploying balloon 320 removal.
Turning now to
Expandable body 400, 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 body 400 may collapse, for instance, by compression and expand, for instance, after deployment as desired.
Expandable body 400, in an embodiment, may also include one or more expandable mechanism (not shown). For example, expandable body 400 may 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 body 400 may also be a metal or plastic frame (e.g., formed by struts 410) with one or more secondary expandable structures attached thereto. In some instance, the expandable mechanism may be inflatable.
Expandable body 400 may contain at least two openings 420, through which undigested, partially digested, or completely digested food can be directed from the stomach into the intestinal sleeve, such as sleeve 130 shown in
In certain embodiments, expandable body 400 may 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 body 400 for 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 body 400 placed inside the stomach may contract and expand as the stomach contracts and relaxes. This way, expandable body 400 may be prevented from being expelled out of the stomach as may occur to a substantially rigid anchor.
Expandable body 400 may 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 body 400 within 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 body 400 tends to move down to the antrum, an intestinal sleeve that is coupled to expandable body 400 may remain anchored in the desired position (e.g., within the antrum). The anchoring effect of the elastic expandable body 400 to 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 body 400 described above, expandable body 400 may 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 to
As illustrated in
It should be noted that
In certain embodiments, the second anchoring mechanism 520 may have a smaller diameter than the first anchoring mechanism 510, so as to fit within the duodenum or along other parts in the small intestine. The second anchoring mechanism 520 may also have a substantially similar or larger diameter than the first anchoring mechanism 510, 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 mechanisms 510 and 520 may expand outwardly against the stomach, duodenum, or small intestine, without significantly overstretching the respective tissue.
The first and second anchoring mechanisms 510 and 520, 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 mechanisms 510 and 520 may be connected by a portion 535 of the sleeve 530, as shown in
In the embodiments illustrated in
Where the second anchoring mechanism 520 is connected to the first anchoring mechanism 510 by multiple tethering mechanisms 550, as shown in
A single tethering mechanism 560 may also be used, as shown in
Tethering mechanisms 550, 560 may be made from any suitable structure or material known in the art. In an embodiment, tethering mechanisms 550, 560 may be a connecting cords, wires, strings, cables, rods, ropes, and the like. The diameter of tethering mechanisms 550, 560 may be sufficiently small so as to not substantially occlude the passageway between anchoring mechanisms 510 and 520 when food passes therethrough. The length of tethering mechanisms 550, 560 may 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 device 500. Alternatively, the length of tethering mechanisms 550, 560 may be custom made for the patient.
Tethering mechanisms 550, 560 may have sufficient flexibility to bend or move along with movement of the patient's body. In an embodiment, tethering mechanisms 550, 560 may be made of spring metal or plastic. In some embodiments, tethering mechanisms 550, 560 may be sufficiently elastic while holding anchoring mechanisms 510 and 520 in 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 mechanisms 510 and 520 adjacent the pylorus. Tethering mechanisms 550, 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 device 500 relative to the pylorus, to the extent that the respective anchoring mechanism 510 or 520 contacts either side of the pylorus.
To the extent desired, anchoring mechanisms 510, 520 and 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 mechanisms 510 and 520 may 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 mechanisms 510 and 520 to allow food to pass through and enter sleeve 530.
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 in
With reference now to
Anchoring mechanisms 510 and 520 may each include a plurality of interconnected members 515 such as loops (
A single tethering mechanism 560 may be provided between anchoring mechanisms 510 and 520 to connect them. More than one tethering mechanisms may also be used, as discussed above. For ease of construction, tethering mechanism 560 may be molded as one piece together with anchoring mechanisms 510 and 520 (e.g., as a metal or plastic structure). Alternatively, these parts can be formed separately and then assembled into the two-anchor device 505. In this case, tethering mechanism 560 may be connected at either end to anchoring mechanisms 510 and 520 by designs 562 and 564 shown in
In a preferred embodiment,
In operation, the first and second anchoring mechanism 510 and 520 may first be secured along a gastrointestinal tract of a patient. For example, the first anchoring mechanism 510 may be secured within a stomach, and the second anchoring mechanism 520 may be secured beyond the stomach, such as in a duodenum. Next, sleeve 530 may be placed about an outer surface of the second anchoring mechanism 520 and extend therefrom into a small intestine. In an embodiment, sleeve 530 may be situated circumferentially about the outer surface of the second anchoring mechanism 520. The second anchoring mechanism 520 may also expand and act to seal sleeve 530 against the wall of the duodenum. This way, food can be directed through first anchoring mechanism 510, second anchoring mechanism 520, and sleeve 530, 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.
The present application is a continuation-in-part application of U.S. patent application Ser. No. 13/007,344 filed Jan. 14, 2011, which claims priority to and the benefit of U.S. Provisional Application No. 61/295,012 filed Jan. 14, 2010, U.S. Provisional Application No. 61/300,663 filed Feb. 2, 2010, and U.S. Provisional Application No. 61/360,653 filed Jul. 1, 2010, the disclosures of all of which applications are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61295012 | Jan 2010 | US | |
| 61300663 | Feb 2010 | US | |
| 61360653 | Jul 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13007344 | Jan 2011 | US |
| Child | 13089722 | US |
