WO2013006588A2

WO2013006588A2 - Devices and methods for treating obesity

Info

Publication number: WO2013006588A2
Application number: PCT/US2012/045325
Authority: WO
Inventors: Chandra A. DUGGIRALA
Original assignee: Novobionics, Inc.
Priority date: 2011-07-01
Filing date: 2012-07-02
Publication date: 2013-01-10
Also published as: WO2013006588A3

Abstract

A method and apparatus for conducting chyme to a first portion of a digestive tract of a patient downstream of the Ampulla of Vater and for conducting bile and pancreatic fluid exiting the Ampulla of Vater to a second portion of the digestive tract of the patient downstream of the Ampulla of Vater, having a chyme stream conduit configured to conduct isolated chyme to a portion of the digestive track to a distal seal assembly of the chyme stream conduit and a bile conduit assembly configured to isolate the bile and pancreatic fluid exiting the Ampulla of Vater and to conduct the bile to a predetermined point in the digestive track downstream of the distal seal assembly of the chyme stream conduit.

Description

DEVICES AND METHODS FOR TREATING OBESITY

CROSS-REFERENCE TO RELATED PATENT APPLICATION

[0001] This application claims the benefit of and priority to U.S. Patent

Application No. 61/504,138 filed on July 1 , 201 1 , which is hereby incorporated by reference in its entirety.

Field

[0002] Described here are devices for treating obesity. The devices are implanted endoscopically, positioned in the stomach and small intestine, and operate to maintain the separation of the chyme stream leaving the stomach from the stream containing bile and pancreatic fluids exiting the Ampulla of Vater until a

predetermined point downstream in the small intestine. The devices, however, permit other digestive fluids to enter the chyme stream and hormones to enter the blood stream.

Background

[0003] Obesity continues to increase in importance as a major health problem. In addition to the obvious musculoskeletal strains, obesity affects the body's organs, particularly the heart and circulatory systems, via hypertension and coronary artery disease. Obesity contributes to an estimated half-million deaths a year along with comorbidities like Type-ll diabetes.

[0004] Obesity is a complex disorder. Nevertheless, the medical consensus is that the cause is simply a combination of an increase in the intake of excessive calories and a reduction in energy expenditure. Although the treatments seem intuitive, they are not easily instituted nor maintained. Dieting is not an effective long- term solution for most obesity disorders. Once an individual has slipped past the BMI of 30, more drastic solutions are often required.

[0005] There are several invasive procedures for reducing consumption and producing long-term weight loss. Two common surgical procedures are the Roux-en- Y gastric bypass and the bilio-pancreatic diversion with duodenal switch (BPD). Both procedures reduce the size of the stomach and shorten the effective length of intestine available for nutrient absorption. Reduction of the stomach size reduces stomach capacity and the ability of the patient to take in food.

[0006] In the BPD procedure, large lengths of jejunum are bypassed resulting in malabsorption and therefore, reduced caloric uptake. In the BPD procedure, the stomach is not reduced in size as much in the Roux-en-Y gastric bypass procedure so that the patient is able to consume sufficient quantities of food to compensate for the reduced absorption. The latter procedure is reserved for the most morbidly obese as there are several serious side effects of prolonged malabsorption.

Interestingly, these procedures also have immediate and therapeutic effect on diabetes II.

[0007] These surgical procedures have some detrimental effects: bypassing the duodenum causes difficulty in digesting fatty, sugary, and complex carbohydrate-rich foods and, should a person eat those foods, that digestion causes a "dumping" syndrome. Dumping occurs when carbohydrates directly enter the jejunum without being first conditioned in the duodenum. That bypassing causes the intestinal lining to discharge a large quantity of fluid into that food. The total effect on the patient is light-headedness and severe diarrhea. Although the cause-and-effect of these symptoms seems straightforward, their exact mechanisms are not well understood. Eventually patients learn that compliance with the dietary restrictions imposed by their modified anatomy alleviates the light-headedness and dumping.

[0008] The morbidity rate for these surgical procedures is comparative with 1 1 % requiring surgical intervention for correction. Early small bowel obstruction occurs at a rate of between 2 to 6% in these surgeries and mortality rates are reported to be approximately 0.5 to 4%. Although surgery seems to be an effective answer, the complication rates associated with current invasive procedures are quite high.

[0009] Accordingly, the present invention provides endoscopically implantable devices and endoscopic techniques to treat obesity and related conditions in order to decrease the types and rates of complications associated with the aforementioned surgical procedures. SUMMARY

[0010] The application relates to systems, apparatus and methods for

conducting chyme to a first portion of a digestive tract of a patient downstream of the Ampulla of Vater and for conducting bile and pancreatic fluid exiting the Ampulla of Vater to a second portion of the digestive tract of the patient downstream of the Ampulla of Vater. In one aspect, the apparatus can comprise a chyme stream conduit assembly and a bile conduit assembly. In various aspects, the chyme stream conduit assembly is configured to conduct isolated chyme to a portion of the digestive tract to a distal seal assembly of the chyme stream conduit assembly and the bile conduit assembly is configured to isolate the bile and pancreatic fluid exiting the Ampulla of Vater and to conduct the bile to a predetermined point in the digestive tract downstream of the distal seal assembly of the chyme stream conduit assembly.

[0011] In one aspect, it is contemplated that the chyme stream conduit assembly can comprise one or more of an elongate chyme conduit, an anchor assembly coupled to a proximal end of the chyme conduit, a proximal seal assembly operably coupled to the anchor assembly, and a distal seal assembly coupled to a distal end of the chyme conduit. In one aspect, the chyme conduit is configured to conduct the isolated chyme to a portion of the digestive track immediately distal to the distal seal assembly.

[0012] In one aspect, the anchor assembly can comprise means for sealing the pylorus of the digestive tract to prevent the passage of chyme into an enclosed volume that is partially defined by an exterior surface of the chyme conduit and the interior surface of the surrounding digestive track and is further defined by the proximal seal assembly and the distal seal assembly. In one aspect, it is

contemplated that the enclosed volume is in fluid communication with the Ampulla of Vater.

[0013] In another aspect, the proximal seal assembly can comprise means for maintaining a fluid tight seal against a portion of the digestive tract immediately distal to the anchoring means. In one aspect, the distal seal assembly can comprise means for maintaining a fluid tight seal against a portion of the digestive tract at a predetermined location distal to the Ampulla of Vater of the digestive tract.

[0014] In one aspect, the bile conduit assembly can comprise an elongate tube in fluid communication with the enclosed volume and a weighted member. It is contemplated that the weighted member can be releasably attached to a second end of the elongate tube. In operation, the releasably coupled weighted member is configured to allow the elongate tube to move from a delivery position, in which the elongate tube is folded to reduce the length, to an operative position, wherein the elongate tube is stretched to its full length and the second end of the elongate tube is positioned at a desired distance downstream of the distal end of the chyme conduit.

[0015] Additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] These and other features of the preferred embodiments of the invention will become more apparent in the detailed description in which reference is made to the appended drawings wherein:

[0017] Figure 1 is a partial cutaway view of the digestive tract between the esophagus and the small intestine.

[0018] Figure 2 schematically shows an apparatus of the present invention deployed therein the partial cutaway view of the digestive tract shown in Figure 1 .

[0019] Figure 3 is a perspective view of a first embodiment of the apparatus showing a bile conduit assembly and a chyme stream conduit assembly comprising an elongate chyme conduit, an anchor assembly coupled to a proximal end of the chyme conduit, a proximal seal assembly operably coupled to the anchor assembly, and a distal seal assembly coupled to a distal end of the chyme conduit. The bile conduit assembly is shown in a pre-deployment position in which at least a portion of the distal end of the elongate tube is folded in an accordion fashion.

[0020] Figure 4 is a perspective view of a second embodiment of the apparatus showing a bile conduit assembly and a chyme stream conduit assembly comprising an elongate chyme conduit, an anchor assembly coupled to a proximal end of the chyme conduit, a proximal seal assembly operably coupled to the anchor assembly, and a distal seal assembly coupled to a distal end of the chyme conduit. The bile conduit assembly is shown in a pre-deployment position in which at least a portion of the distal end of the elongate tube is folded in an accordion fashion.

[0021] Figure 5 is a perspective view of a third embodiment of the apparatus showing a bile conduit assembly and a chyme stream conduit assembly comprising an elongate chyme conduit, a proximal seal assembly to a proximal end of the chyme conduit, and a distal seal assembly coupled to a distal end of the chyme conduit. The bile conduit assembly is shown in a pre-deployment position in which at least a portion of the distal end of the elongate tube is folded in an accordion fashion.

[0022] Figure 6 is a perspective view of the apparatus showing an elongate chyme conduit, a proximal seal assembly operably coupled to a proximal end of the chyme conduit, and a distal seal assembly coupled to a distal end of the chyme conduit.

[0023] Figure 7 is a perspective view of one embodiment of a nitinol anchor assembly.

[0024] Figure 8 is a side elevational view of the anchor assembly of Figure 7.

[0025] Figure 9 is a perspective view of a second embodiment of an anchor assembly.

[0026] Figure 10 is a partial cutaway perspective view of the anchor assembly of

Figure 9. DETAILED DESCRIPTION

[0027] The present invention can be understood more readily by reference to the following detailed description, examples, drawing, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the

terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

[0028] The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain

circumstances and are a part of the present invention. Thus, the following

description is provided as illustrative of the principles of the present invention and not in limitation thereof.

[0029] As used throughout, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "an assembly" can include two or more such assemblies unless the context indicates otherwise.

[0030] Ranges can be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0031] As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance can or can not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0032] "Sealing" means that substantially no chyme, in particular, less than 5%, less than 4%, less than 3%, less than 2%, less than 1 %, or substantially 0%, of the chyme passing out of the stomach 120 over a particular elapsed time period, passes exterior to the apparatus 100 by the region having the sealing function. Alternatively, by "sealing" is meant that substantially no bile or pancreatic enzymes, in particular, less than 5%, less than 4%, less than 3%, less than 2%, less than 1 %, or

substantially 0%, of the bile or pancreatic enzymes passing out of the Ampulla of Vater 1 16 over a particular elapsed time period, passes interior to the apparatus 100 by the region having the sealing function.

[0033] Embodiments provided herein comprise an apparatus 10 that can be configured to treat obesity and related conditions when positioned within a living being. It is contemplated that the apparatus 10 can be positioned in at least the stomach and duodenum and is configured to maintain separation of the chyme stream leaving the stomach and the stream of bile and pancreatic fluid exiting the Ampulla of Vater until a predetermined point downstream in the small intestine. The apparatus, however, permits other digestive fluids to enter the chyme stream and hormones to enter the blood stream. Other embodiments provided herein include methods for manufacturing, delivering and using an apparatus configured to treat obesity and related conditions.

[0034] Referring generally to Figures 1 and 2, in one aspect, the system and apparatus 10 provides a means for conducting chyme to a first portion of a digestive tract of a patient downstream of the Ampulla of Vater and for conducting bile and pancreatic fluid exiting the Ampulla of Vater to a second portion of the digestive tract of the patient downstream of the Ampulla of Vater. In one aspect, the system and apparatus can comprise a chyme stream conduit assembly 20 and a bile conduit assembly 30. In various aspects, the chyme stream conduit assembly 20 is configured to conduct isolated chyme to a portion of the digestive track to a distal seal assembly of the chyme stream conduit assembly and the bile conduit assembly 30 is configured to isolate the bile and pancreatic fluid exiting the Ampulla of Vater and to conduct the bile to a predetermined point in the digestive track downstream of the distal seal assembly of the chyme stream conduit assembly.

[0035] In one aspect, it is contemplated that the chyme stream conduit assembly can comprise one or more of an elongate chyme conduit 1 10, an anchor assembly 120 coupled to a proximal end 1 12 of the chyme conduit, a proximal seal assembly 130 operably coupled to the anchor assembly, and a distal seal assembly 140 coupled to a distal end 1 14 of the chyme conduit. Optionally, and as shown in Figure 5, the apparatus 10 may not have an anchor assembly 120. In this aspect, the proximal seal assembly provides the necessary chyme sealing function.

[0036] In one aspect, the chyme conduit 1 10 is configured to conduct the isolated chyme to a portion of the digestive track immediately distal to the distal seal assembly 140. As one skilled in the art will appreciate, the chyme conduit can be configured to maintain separation between the chyme exiting the stomach and fluids that would otherwise enter the chyme stream at a point distal to the stomach, e.g., bile and pancreatic fluids.

[0037] In one aspect, the anchor assembly 120 can comprise a means for sealing the pylorus of the digestive track to prevent the passage of chyme into an enclosed volume 40 that is partially defined by an exterior surface 1 16 of the chyme conduit 1 10 and the interior surface of the surrounding digestive track and, as one will appreciate, can be further defined by the proximal seal assembly 130 and the distal seal assembly 140. In one aspect, it is contemplated that the enclosed volume is in fluid communication with the Ampulla of Vater. In another aspect, the anchor assembly 120 can function at least in part to support and prevent migration of the apparatus relative to the implanted location within the digestive track, and can also optionally function to substantially seal the apparatus 10 against the wall of the digestive tract, e.g., within the stomach, pylorus, or duodenum.

[0038] In another aspect, the proximal seal assembly 130 can comprise means for maintaining a fluid tight seal against a portion of the digestive tract immediately distal to the anchoring means. In one aspect, the distal seal assembly can comprise means for maintaining a fluid tight seal against a portion of the digestive tract at a predetermined location distal to the Ampulla of Vater of the digestive tract. In one aspect, the distal seal assembly can act at least in part to maintain a separation between the chyme inside the apparatus 10 and digestive fluids situated outside the apparatus.

[0039] In a further aspect and as depicted in Figure 6, the proximal seal assembly and the distal seal assembly can be configured to maintain the at least one enclosed volume 40 defined, as described above, additionally by at least the digestive tract wall, the anchor assembly, and the chyme conduit. In one exemplary aspect, the enclosed volume 40 can be sized and shaped to collect, and optionally store, a desired quantity of fluid expressed from the Ampulla of Vater. In a further aspect, it is contemplated that the bile conduit assembly is in fluid communication with the enclosed volume 40 and is configured to transport the separated bile and pancreatic fluids to or towards a desired position within the digestive tract, which, in one example, can be proximate to the ileum for release there.

[0040] In one aspect, the bile conduit assembly 30 can comprise an elongate tube 150 in fluid communication with the enclosed volume and a weighted member 160. It is contemplated that the weighted member 160 can be releasably attached to a second, distal end 154 of the elongate tube. In operation, the releasably coupled weighted member 160 is configured to allow the elongate tube to move from a delivery position, in which the elongate tube is folded to reduce the length, to an operative position, wherein the elongate tube is stretched to its full length and the second end of the elongate tube is positioned at a desired distance downstream of the distal end of the chyme conduit. [0041] In one aspect, the apparatus 10 can extend from the stomach in the region of the pylorus, through the pylorus, through at least a portion of the duodenum -- specifically past the Ampulla of Vater - and into the ileum section of the small intestine. In the example shown in Figure 2, the anchor assembly of the apparatus 10 can reside at least partially in the stomach and can be fixed to the pylorus.

Optionally, the apparatus 10 can be sealed to a desired portion of the digestive track, such as, for example and without limitation, the wall of the stomach, or against the pylorus, or against the wall of the duodenum, or any combination thereof by the anchor 102.

[0042] Anchor Assembly

[0043] More particularly, in aspects of the invention and referring to Figures 2, 3, and 7-10, the anchor assembly is positioned proximate or at the proximal most end of the apparatus 10 and is configured to be selectively movable between a delivery position, in which the anchor assembly has a reduced outside diameter, and an operative position, in which the anchor assembly has an expanded outside diameter that is positioned in contact against at least a portion of the wall of the digestive tract. It is contemplated that the anchor assembly can serve both anchoring and sealing functions. In one aspect, the anchor assembly is configured at least in part to ensure the undesired portions, or even the entire device, are not pulled into the stomach or otherwise displaced from its deployed location. In one aspect, the anchor assembly can be configured to seal the pylorus to prevent the passage of chyme into the enclosed volume 40 outside of the chyme conduit 1 10. Thus, in various aspects, it is contemplated that the anchor assembly can be positioned in contact with at least a portion of the digestive tract selected from the group comprising the stomach, the pylorus and the duodenum.

[0044] It is also contemplated that the anchor assembly can have different shapes. It is further contemplated that the anchor assembly can perform other functions ancillary or auxiliary to the fixation function, e.g., provide temporary stomach volume reduction, exude drugs for treatment, and slow or delay passage of chyme through the opening of the chyme conduit 1 10 in the apparatus 10, thus causing a delay in emptying of the stomach.

[0045] In another aspect of the invention and as shown in Figures 7-10, a least a portion of the anchor assembly can have a geometry that approximates a toroid. That is, it is contemplated that the anchor assembly can further comprise a cylindrical wire structure in the delivery position that is configured to form a toroidal wire structure in the operative position. In this configuration, at least one wire can be formed via conventional techniques known in the art of stent making to form an atraumatic, substantially toroidal member. In a further aspect, at least a portion of the woven frame of the anchor assembly can be coated in a polymer. In one aspect, the polymer can be a suitable biocompatible polymer, such as, for example and without limitation, silicone or a polyurethane having a durometer of less than about 60 Shore A, more preferably, less than about 50 Shore A and, most preferably, about 40 Shore A. having a diameter of about 40 Shore A.

[0046] Optionally, the anchor assembly can have a geometry that approximates a toroid whose inner hole forms the proximal-most end of the chyme conduit 1 10. In one aspect, the anchor assembly can be formed from at least one wire woven via conventional techniques, not described herein, to form a cylindrical sleeve. In another aspect and as shown in Figures 7 and 8, it is contemplated that one end of the cylindrical sleeve can be turned outwards towards the opposite end to form a section that generally forms a portion of a toroid. In one example, the toroidal shape can have a plurality of upper petals and a plurality of opposed lower petals. This opposing "petal" structure gives the anchor assembly a desired balance of rigidity and stiffness while ensuring the device is sufficiently collapsible for endoscopic delivery. The respective apexes of the plurality of upper petals and the opposed apexes of the plurality of lower petals can be substantially oriented in line with or spaced apart from each other, e.g., the upper petals and lower petals can be positioned in overlying or offset configuration. It is contemplated that the respective pluralities of upper and lower petals can range from 2 petals each to up to about 15 petals each, from 4 petals each to up to about 13 petals each, and more preferably from about 6 petals each to about 12 petals each. In one non-limiting aspect, the anchor assembly can comprise 6 upper petals and 6 lower petals. Optionally, each of the respective pluralities of upper and lower petals can have the same or different number of petals.

[0047] In further aspect, at least a portion of the formed wire petals of the anchor assembly can be coated in a polymer. In one aspect, the polymer can be a suitable biocompatible polymer, such as, for example and without limitation, medical-grade silicone or a polyurethane. The material coating the exterior surface of the petals can have a durometer of less than about 60 Shore A, more preferably, less than about 50 Shore A and, most preferably, about 40 Shore A.

[0048] In another aspect, a plurality of spokes can extend from each free end of the cylindrical wire structure of the anchor assembly. In one exemplary aspect, the plurality of spokes comprises six spokes. It is contemplated that the plurality of spokes can comprise less than or greater than six spokes. In a further aspect, the anchor assembly can be configured to actuate from a delivery to an operative position by one free end of the cylindrical wire structure folding inward to form the toroidal wire structure.

[0049] The device can further comprise at least one connecting member 126 that is coupled to and extend between the anchor assembly and the proximal seal assembly. It is contemplated that the at least one connecting member 126 can comprise a plurality of connecting members. In one exemplary aspect, it is

contemplated that each connecting member 126 can comprise thread, such as silk thread or any other thread known in the art with sufficient strength and

biocompatability for the present purpose. Use of the connecting member 126 to connect the anchor assembly and proximal seal assembly helps to fix the distance between the anchor assembly and proximal seal assembly thereby protecting the sleeve portion of the chyme conduit 1 10 from an undesirable degree of stretching or deformation while providing minimal resistance to pyloric opening and closing.

Optionally, the connecting members 126 can be a continuous part of a weave or laser cut metal structure that forms the anchor assembly. In other aspects, the plurality of connecting members 126 is configured to maintain the intended orientation of the anchor section in the stomach by resisting rotational twisting that could occlude the chyme conduit 1 10 whose entrance is the center of the toroid of the anchor assembly. In a further aspect, the plurality of connecting members 126 can be configured helically to further provide an anti-twist mechanism.

[0050] Proximal Seal Assembly

[0051] In another aspect, shown in at least Figure 6, the apparatus 10 comprises a proximal seal assembly 130 that is configured to be selectively affixed in the pylorus or proximal to the pylorus in the stomach. In one aspect, it is contemplated that the proximal seal assembly 130 can be configured as a stent-like device and can be connected, as described above, to the anchor section via the plurality of connecting members 126. As illustrated, the proximal seal assembly 130 can be configured so that it can not only provide the initial seal when the apparatus 10 is implanted but will maintain the desired seal against the digestive tract wall as the digestive tract wall naturally attempts to remodel in response to the outward radial force exerted by the proximal seal assembly. Thus, the proximal seal assembly 130 can be configured to expand from about 1 .5 to about 3 times, more particularly from about 2 to about 2.7 times, and most particularly from about 2.2 times to about 2.5 the initial deployed diameter. Thus, the proximal seal assembly can have a first expanded state upon deployment and a second expanded state that is reached when the intestine has remodeled and equilibrium between the intestine and proximal sealing section is reached. Further, the expressed force exerted by the proximal scaling section on the digestive tract wall is sufficient, upon deployment, to resist, particularly, at least 0.5 lbs, at least 1 lbs, and preferably at least 1 .6 lbs, of tensile force before being displaced relative to the deployed location.

[0052] In one aspect, the proximal seal assembly 130 can comprise an expandable stent-like structure and can be formed by at least one wire. In one aspect, the distal end of the stent-like structure can be coupled to and support a proximal end portion 1 12 of the chyme conduit 1 10. In a further aspect, the proximal seal assembly 130 is configured as a plurality of single-wire stents with three upper and three lower apices to widen the deployed angles, where each adjacent single- wire stent is connected by plurality of wires. In this aspect, the stent-like structures deploy to an operative position where they approximate a ring. The proximal seal assembly 130 can be configured to be movable about and between a partially collapsed configuration, which may be used during delivery of the device and an expanded configuration in the desired position in the digestive track. Optionally, the proximal seal assembly 130 can be self-expanding or expandable using an

expanding tool such as a balloon or other conventional shaping tool. In operation, as shown in Figure 2, the proximal seal can be positioned proximate the proximal pylorus. As one will appreciate, at least a portion of the proximal seal assembly 130 can extend into the distal stomach as desired.

[0053] Distal Seal Assembly

[0054] In an additional embodiment shown, the apparatus 10 can comprise a distal seal assembly 140 that is configured to be selectively affixed in a location distal to the Ampulla of Vater in the digestive tract. In one aspect, the distal seal assembly 140 can be operable to maintain at least one enclosed volume 40 defined additionally by the digestive tract wall, the proximal seal assembly, and the chyme conduit. In this aspect, the distal seal assembly 140 defines a lower surface of the volume that is configured to collect and optionally store bile and pancreatic fluids expressed from the Ampulla of Vater. A desired separation is maintained between the chyme inside the chyme conduit 1 10 of the apparatus 10 and fluids such as bile and pancreatic fluids situated outside the apparatus 10 or within the bile conduit assembly 30.

[0055] In one aspect, the distal seal assembly 140, can comprise an expandable stent-like structure, which can be formed by at least one wire. In a further aspect, the distal end of the stent-like structure can be coupled to and support a distal end portion of the chyme conduit 1 10 as well as comprise an additional length of stent- like structure operable to prevent tilting of the distal seal assembly 140. In yet a further aspect, the distal seal assembly can be configured as a plurality of single-wire stents with three upper and three lower apices to widen the deployed angles, where each adjacent single-wire stent is connected by plurality of wires. In this aspect, the stent-like structures deploy to an operative position where they approximate a ring. [0056] In one aspect, the distal seal assembly 140 is configured to be movable about and between a partially collapsed configuration, which may be used during delivery of the device and an expanded configuration in the desired position in the digestive track. Optionally, the distal seal assembly 140 can be self-expanding or expandable using an expanding tool such as a balloon or other conventional shaping tool. In operation, as shown in Figure 2, the distal seal is positioned distal to the Ampulla of Vater. In another aspect, it is contemplated that the distal seal assembly that terminates the chyme conduit 1 10 is substantially similar in design, deployment and function as the proximal seal assembly 130.

[0057] Chyme Conduit

[0058] In one aspect, the chyme conduit 1 10 originates at or proximate to the hole of the anchor assembly and continues to or proximate to the termination of the distal seal assembly 140. In one aspect, the chyme conduit 1 10 can comprise the interior of the shape circumscribed by the assembly that makes up the anchor assembly, the connecting members 126, the proximal seal assembly, the connecting members 1 18, and the distal seal assembly. The chyme conduit 1 10 can comprise a sleeve or tube portion that is formed of biocompatible materials. In one aspect, at least a portion of the sleeve portion can have anti-stick properties. It is contemplated that the sleeve portion can be formed from a polymer or fabric, which can be coupled or otherwise attached to the frame in a number of conventional methodologies, such as, but not limited to, molding, sewing and the like.

[0059] In one aspect, it is contemplated that at least the portion of the wall of the chyme conduit 1 10 passing through the pylorus can further have a desired degree of flexibility that allows for the operative coupling of the body's natural peristalsis to the sleeve's internal passageway. As one skilled in the art will appreciate, this configuration of the sleeve allows the pylorus to be used as a natural stoma in that the pylorus (and the proximal end of the sleeve) closes and then opens to allow passage of food when the muscles of the pylorus relax. In this aspect, the chyme conduit can have enough wall flexibility or compliance to allow normal opening and closing of the pylorus to release and retain stomach contents and to allow drainage of chyme through the interior of the chyme conduit 1 10. Optionally, and as shown in Figure 1 , the chyme conduit 1 10 can be configured to include at least one fold, pleat, channel, and/or other structures in the chyme conduit to facilitate the selective and operative collapse or expansion of the chyme conduit.

[0060] The device can further comprise a second plurality of connecting members 1 18 that are coupled to and extend between the proximal seal assembly and the distal seal assembly. These connecting members 1 18 can comprise thread, such as silk thread or any other thread known in the art with sufficient strength and biocompatibility for this purpose. As one skilled in the art will appreciate, the use of thread to connect the proximal seal assembly and distal seal assembly fixes the distance between the proximal and distal seal assemblies, hereby protecting the chyme conduit from stretching or deformation while providing minimal resistance to the natural peristalsis of the body. The plurality of connecting members 1 18 can be, in another aspect, configured in a helical or spiral shape to help continuously urge the chyme conduit 1 10 to remain open and to resist any twisting forces that could cause the conduit section to undesirably kink, become obstructed, and/or collapse. One skilled in the art will appreciate however that, in this aspect also, the apparatus' minimal framework and use of a polymer or fabric sleeve or tube allows the natural peristalsis of the intestine to urge or propel the chyme through the chyme conduit 1 10 and into a desired downstream portion of the intestine.

[0061] An exemplary chyme conduit 1 10 is shown in Figures 1 and 2. The chyme conduit 1 10 can comprises a tube having a substantially cylindrical wall, the exterior of which can form an annular volume with the duodenal wall. As one will appreciate, the interior of the chyme conduit 1 10 can define a passageway for chyme from the stomach.

[0062] Bile Conduit Assembly

[0063] In one aspect, the apparatus 10 further comprises a bile conduit assembly 30 that can be configured to collect bile and pancreatic enzymes passing out of the Ampulla of Vater and/or maintain substantial separation between the bile and pancreatic enzymes stream passing from the Ampulla of Vater from the chyme stream over the length of the bile conduit assembly. In one aspect, the bile conduit assembly 30, which contains bile and pancreatic fluids exiting the Ampulla of Vater, can, in a fully isolated fashion, pass through that annular volume and continue to the distal end of the bile conduit assembly 30 where it re-enters the digestive tract as further discussed below.

[0064] In one aspect, the elongate tube 150 of the bile conduit assembly 30 can be configured to be attached proximal to the distal seal assembly and placed in fluid communication with the enclosed volume 40 between the digestive tract wall and the exterior of the chyme conduit 1 10. In one exemplary aspect, in order to join the elongate tube 150 to the chyme conduit 1 10, a port 1 13 to accommodate the elongate tube 150 is formed in the chyme conduit 1 10 and then a polymer, adhesive or the like is used to resiliently fix and seal the first end 152 of the elongate tube 150 thereto the formed port 1 13. The elongate tube 150 of the bile conduit assembly is configured to transport the separated bile and pancreatic fluids to or towards the ileum for release.

[0065] In one aspect, the at least one bile conduit assembly 30 can be formed from a material similar to the material described above forming the chyme conduit 1 10 In one non-limiting example, the at least elongate tube 150 can be formed at least in part from a polymer which also can have anti-sticking properties. In one example, the polymer can be PTFE. In another aspect, it is desirable that the at least elongate tube 150 be configured to be substantially non-collapsible.

[0066] In another aspect, the elongate tube 150 can further comprise a spiral wire support extending the substantial length of the at least elongate tube 150. As one skilled in the art will appreciate, the spiral wire support can help the bile conduit assembly 30 remain open and to resist any applied forces that could cause the elongate tube 150 to undesirably kink, become obstructed, and/or collapse. In a further aspect, the ratio of the operative diameters of the chyme conduit 1 10 and the elongate tube 150 can range from about 5:1 , 4:1 , 3:1 , or 2:1 .

[0067] In another aspect, the elongate tube 150 of the bile conduit assembly 30 can have a weighted member 160 that is configured to be releaseably attached to the second, distal end 154 of the elongate tube 150 operable to facilitate deployment of the elongate tube 150 of the bile conduit assembly 30 via peristalsis. In this aspect, it is contemplated that the releasable weighted member 160 can allow the elongate tube to move from a delivery position, in which the elongate tube 150 is folded to reduce the length, to an operative position, wherein the elongate tube is stretched to its full length and the second end of the elongate tube is positioned at a desired distance downstream of the distal end of the chyme stream conduit assembly. In one aspect, the elongate tube 150 of the bile conduit assembly 30 can be folded in an accord ion -I ike fashion in the delivery position.

[0068] On one aspect, the weighted member 160 is releaseably attached to the bile conduit with a biodegradable adhesive having a known decomposition profile, such as a collagen adhesive. The weighted member can be a ceramic ball and can have a diameter ranging from about 1 mm to about 10 mm in diameter.

[0069] Optionally, the bile conduit assembly 30 can be configured to provide temporary storage of the bile and pancreatic enzymes and/or provide slowed or delayed passage of chyme through the chyme conduit in the apparatus in the region of the bile conduit assembly, or provide a sealing function with the digestive tract wall proximal of the Ampulla of Vater. The temporary storage of bile and pancreatic enzymes can allow for the delayed release of bile and pancreatic enzymes into a region of the ileum until a majority of chyme has passed through that region of the small intestine.

[0070] In another aspect, the bile conduit assembly 30 can comprise a plurality of tubular conduits configured to transport the bile and pancreatic enzymes collected in the volume of the separator section for a selected distance into the ileum and to emit them there. As one will appreciate, the elongate length of the tubular conduits can be selected to traverse the selected distance or distances. In one aspect, the tubular conduits can be of equal or unequal length as desired.

[0071] In another aspect, at least a portion of the bile conduit assembly 30 can comprise a strip of radio opaque material integral to the conduit wall. As one will appreciate, the strip can allow for visualization via x-ray of the positioning of the conduit in the digestive tract without hiding the contents of the bile conduit assembly 30. The radio-opaque material, for example, can be mixed with and coextruded with the elongate tube 150. In an aspect, suitable radio-opaque materials can comprise fine particulates of barium sulfate, bismuth oxychloride, bismuth subcarbonate, bismuth trioxide, tungsten, gold, tantalum, platinum, and the like.

[0072] Delivery

[0073] In another aspect, an endoscopic delivery apparatus is provided. The endoscopic delivery apparatus can have a maximum diameter of between about 2.8 to about 3.0 mm. In various aspects, the maximum length of the delivery apparatus can be between about 10 to about 15 mm, more preferably from between about 1 1 to about 14 mm, and most preferably from between about 12 to about 13 mm. In one aspect, the delivery apparatus can comprise a small light, such as a LCD chip, to ease navigation to the desired deployment site. In one aspect, it is contemplated that the anchor assembly, the distal seal assembly and, optionally, the proximal seal assembly are deployed in their respective desired anatomical positions via

conventional techniques such as ballooning or expansion of shape-memory metals. Finally, the elongate tube 150 of the bile conduit assembly 30 can be deployed by letting peristalsis carry the releaseable weighted member downstream to the desired location.

[0074] Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is thus understood that the invention is not limited to the specific embodiments disclosed hereinabove, and that many

modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although specific terms are employed herein, as well as in the claims which follow, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention, nor the claims which follow.

Claims

CLAIMS What is claimed is:

1 . An apparatus for conducting chyme to a first portion of a digestive tract of a patient downstream of the Ampulla of Vater and for conducting bile and pancreatic fluid exiting the Ampulla of Vater to a second portion of the digestive tract of the patient downstream of the Ampulla of Vater, comprising: a chyme stream conduit assembly comprising: an elongate chyme conduit; an anchor assembly coupled to a proximate end of the chyme conduit and comprising means for sealing the pylorus of the digestive tract to prevent the passage of chyme into an enclosed volume that is partially defined by an exterior surface of the chyme conduit and the interior surface of the surrounding digestive tract; a proximal seal assembly operably coupled to the anchor assembly and comprising means for maintaining a fluid tight seal against a portion of the digestive tract immediately distal to the anchoring means and connected to the anchoring means by threads; a distal seal assembly coupled to a distal end of the chyme conduit and comprising means for maintaining a fluid tight seal against a portion of the digestive tract at a predetermined location distal to the Ampulla of Vater of the digestive tract; wherein the enclosed volume is further defined by the proximal seal assembly and the distal seal assembly, wherein the enclosed volume is in fluid communication with the Ampulla of Vater, and wherein the chyme conduit is configured to conduct the isolated chyme to a portion of the digestive track immediately distal to the distal seal assembly; a bile conduit assembly configured to isolate the bile and pancreatic fluid exiting the Ampulla of Vater and to conduct the bile to a predetermined point in the digestive track downstream of the distal seal assembly of the chyme stream conduit, the bile conduit assembly comprising: an elongate tube positioned having a first end coupled to a port defined in the chyme conduit, wherein the first end of the elongate tube is in fluid communication with the enclosed volume; a weighted member releasably attached to a second end of the elongate tube that is configured to allow the elongate tube to move from a delivery position, in which the elongate tube is folded to reduce the length, to an operative position, wherein the elongate tube is stretched to its full length and the second end of the elongate tube is positioned at a desired distance downstream of the distal end of the chyme conduit.

2. The apparatus of Claim 1 , wherein the anchor assembly is selectively movable between a delivery position, in which the anchor assembly has a reduced outside diameter, and an operative position, in which the anchor assembly has an expanded outside diameter that is positioned in contact against at least a portion of the wall of the digestive tract.

3. The apparatus of Claim 2, wherein the proximal seal assembly is selectively movable between a delivery position, in which the proximal seal assembly has a reduced outside diameter, and an operative position, in which the proximal seal assembly has an expanded outside diameter that is positioned in contact with at least a portion of the wall of the digestive tract.

4. The apparatus of Claim 3, wherein the distal seal assembly is selectively movable between a delivery position, in which the distal seal assembly has a reduced outside diameter, and an operative position, in which the distal seal assembly has an expanded outside diameter that is positioned in contact with at least a portion of the wall of the digestive tract.

5. The apparatus of Claim 4, wherein the distal seal assembly further comprises a sealing portion and an elongate portion configured to prevent tilting of the distal seal assembly.

6. The apparatus of Claim 1 , wherein the chyme conduit comprises a polymer tube and at least one thread coupled to and extending between the proximal seal assembly and the distal seal assembly, wherein the at least one connecting member is configured to prevent elongation of the polymer by substantially fixing the distance between the proximal seal assembly and the distal seal assembly.

7. The apparatus of Claim 1 , wherein the anchor assembly is positioned in contact with at least a portion of the digestive tract selected from the group comprising the stomach, the pylorus and the duodenum.

8. The apparatus of Claim 1 , wherein the anchor assembly is positioned in contact with the pylorus.

9. The apparatus of Claim 2, wherein the anchor assembly further comprises a cylindrical wire structure in the delivery position that is configured to form a toroidal wire structure in the operative position.

10. The apparatus of Claim 9, wherein a plurality of spokes extend from each free end of the cylindrical wire structure of the anchor assembly.

1 1 . The apparatus of Claim 10, wherein the plurality of spokes comprises six spokes.

12. The apparatus of Claim 10, wherein the anchor assembly actuates from a delivery to an operative position by one free end of the cylindrical wire structure folding inward to form the toroidal wire structure.

13. The apparatus of Claim 1 , wherein the proximal seal assembly further comprises at least one stent structure, the stent structure comprising a single wire having three apices.

14. The apparatus of Claim 13, wherein the proximal seal assembly comprises two stent structures connected by a plurality of threads.

15. The apparatus of Clainn 1 , wherein the distal seal assembly further comprises at least one stent structure, the stent structure comprising a single wire having three apices.

16. The apparatus of Claim 15, wherein the distal seal assembly comprises a first stent structure and a second stent structure that is coupled to a distal end of the first stent structure.

17. The apparatus of Claim 1 , wherein the weighted member is a ceramic ball.

18. The apparatus of Claim 17, wherein the ceramic ball is from about 1 mm to about 10mm in diameter.

19. The apparatus of Claim 1 , wherein the bile conduit assembly further comprises a biodegradable adhesive that releasably couples the weighted member to the second end of the elongate tube.

20. The apparatus of Claim 1 , wherein the elongate tube of the bile conduit assembly is folded in an accordion-like fashion in the delivery position.