Title of Invention

STOMACH PROSTHESIS

Abstract The invention relates in an implantable prosthesis surgically replacing or segmentinfg all or part of the antern and/or pylorus of a suitable. The prosthsis Controls the passage of food from the stomach to the small intensine. The prosthesis may be configured to churn ingested material and release; it from the stomach through a prosthesis pyloric valve. At least one expandable member is an anged in be expanded 10 control the passage of food and/or to mimic the churning action of a patienti stomach. The prosthesis includes outer support structure, a flexible inner member forming a conduit for the movement of material, and at least one expandable member located between the outer support structure and inner member. An Implantable pump system is provided for inflating and deflating the expandable member(s).
Full Text Field of the Invention :

The invention relates to a stomach prosthesis for the mixing of materials in the. stomach and/or the transport of materials through the stomach. In particular, the invention relates to a prosthetic stomach for replacing or augmenting a portion of the stomach, e. g., the pylorus and/or antrum.

Background of the Invention:

In general when food is ingested into the stomach, initially, the elastic upper portion or fundus accommodates the food and the fundus expands. As food enters and the fundus expands there is a pressure gradient created in the stomach between the fundus and the antrum (fundus pylori). A number of things occur at this time. Fluids tend to be pushed through the pylorus, which acts as a leaky valve. Peristaltic contractions move down the stomach from the fundus into the antrum to mix and break down food and propel small particles through the pylorus into the duodenum. In healthy human stomachs, peristalsis is believed to be controlled at least in part by a region of the stomach identified near the interface of the fundus and the corpus along the greater curvature. In this region, there are cells believed to govern the organs'periodic contractile behavior that generate and propagate rhythmic electrical signals that correspond to the contractile behavior of the stomach. These characteristic contractions are believed to create, a pressure gradient between the fundus pylori (or antrum) and duodenum that relates to the rate of gastric emptying. When the contractions begin, the pylorus is generally closed, although fluid and small particles leak through the valve. As contractions or electrical activity corresponding to the contractions reach pylorus, the pylorus begins to open or relax. Thus, as the stomach churns and breaks down food in a healthy stomach, the pylorus opens. As this is occurring, there may be electrically activity in the duodenum as well. Retrograde electrical activity from the duodenum, i.e. contractions or electrical activity in the direction of thepylorus tends to cause thepylorus to close, thus preventing bile and pancreatic juices from backing up into the stomach. Accordingly, the opening and closing of the pylorus is influenced by input from both of its ends.

In a number of disease states or conditions, the contractions of the stomachand/or the

opening and closing of the pylorus is irregular.Go D contractions to churn food, move food through the pylorus, and/or open the pylorus, among other things, resulting in gastro retention of food. In another motility disorder known as dumping syndrome, the stomach empties at an abnormally high rateinto. the small, intestine. causing various gastrointestinal disorders. It is also believed that obesity may be treated by altering gastric motility or by causing the stomach to retain food for a greater duration to slow gastric emptying.

Accordingly, it would be desirable to provide a device and method for treating motility disorders of the stomach and/or obesity.

In some disease states, portions of the stomach and/or pylorus do not function properly or may require resection. Accordingly, it would be desirable to provide a prosthetic stomach for replacing or augmenting all or part of a stomachand/or pylorus.

Summarv of the Invention :

The present invention provides a prosthesis device and method for replacing or augmenting all or part of the pylorus or antrum of the stomach.

In one embodiment, the prosthesis is designed to facilitate or expedite mixing or breaking down of food matter or liquids in the stomach. In another embodiment, the prosthesis is designed to control, facilitate or expedite movement of food matter or liquids through the pylorus and into the small intestine. In another embodiment, the prosthesis is designed to delay passage of food from the stomach and into the small intestine.

One embodiment of the present invention provides an implantable stomach prosthesis forsurgically replacing all or part of the antrum and pylorus of a stomach. The stomach prosthesis is configured to churn ingested material and release it from the stomach through a prosthetic pyloric valve. In one embodiment a plurality of expandable members are arranged to be expanded in a sequence that mimics the churning action of a patient's stomach. The stomach prosthesis includes an outer support structure to be sewn on one end to the upper portion of the stomach and an opposite end to the duodenum. The prosthesis further includes an expandable member or members located within the outer support structure, and a flexible inner member forming a conduit for the movement of material. The flexible inner member is located within the outer member and-the expandable member or members are located between the inner member and the outer support structure. The expandable members are

expanded and contracted, or inflated and deflated t
In one embodiment of the invention, the implantable prosthesis further comprises an implantable pump system that includes a pump and a programmable controller. According to this embodiment, the expandable members are balloons configured to receive an inflation medium to expand the expandable members. The implantable pump system includes a reservoir of sterile inflation medium used to inflate the various expandable members. The reservoir may be implantable separate from the pump, e.g. in soft tissue. In general, the pump system is a closed system where the inflation medium is stored or transported as it is pumped from one inflation member to another. The prosthesis may be divided along its length into sections. A section may include a single expandable member or a plurality of expandable members that may be separately inflated or may share a conduit coupled to a single output port and valve on the pump. Preferably, each of the expandable members or sections of expandable members has an input port and valve coupled to the pump such that only one valve is opened at a time. However, the system may alternatively have more than one valve open at a time.

The controller controls the inflation and deflation of the expandable members by controlling the opening and closing of the valves coupled to each of the expandable members, and by controlling the pump direction and pressurization of the expandable members. In one embodiment, the inflatable members are inflated to a predetermined pressure. The pump may determine the inflation pressure by monitoring the pumping action or work of its motor. The inflation pressure may also be sensed by sensors that sense the pressure of the system, e. g. in the fluid header of the pump system. According to one embodiment, in a first churning mode, a first section of expandable members corresponding to a first section of the antrum is inflated, then a second adjacent section is inflated. The second section is inflated before the first section is deflated so that the material in the prosthesis cannot move back in an orad direction when the second section is inflated a number of subsequent inflation member sections may then be inflated and deflated in a manner that mimics the stomach's mixing and

churning of food material. In this mode, theprosthetie pyloric valve may be partially open to permit liquid and small particles to pass through the pylorus into the small intestine.

A second mode may be employed to empty the stomach. According to one embodiment of this second mode, -a first-section of expandable members corresponding to a first section of the antrum is inflated, then a second adjacent section is inflated. The second section is inflated before the first section is deflated so that the material in the prosthesis cannot move back in an orad direction when the second section is inflated. The first section is then deflated. Then the third section is inflated, etc. until the section adjacent the pylorus is inflated. According to this mode the pylorus may be opened further to permit passage of more food material. If the food has not been sufficiently broken down to pass through the pylorus, the churning mode may be repeated.

In either of these modes sensors may be employed on each side of the pyloric valve to sense pressure or changes in pressure. The pyloric valve may be relaxed or tightened depending on the sensed pressure. For example, if there is an increased pressure from the duodenum side of the pyloric valve, the pyloric valve is tightened to prevent back flow of material, e. g. , bile, from the small intestine. If there is an increased pressure from the stomach side of the pyloric valve, the valve may be relaxed to permit movement of material from the stomach into the small intestine.

The controller may also control selection of a section of the stomach organ for the churning or breaking down of material. The controller may control selection of sections of the organ for peristaltic movement or moving material through the stomach organ.

Accordingly, sections may be selected according to a desired sequence of the section actuation. The controller may be preprogrammed to control the peristalsis pattern or may be reprogrammed externally or in response to sensed conditions at various locations in the prosthesis. For example the sensors may sense presence or absence of material in the prosthesis and may direct a pattern of peristaltic movement in the various sections accordingly.

In one embodiment, a single electromechanical device actuates the opening and closing of the valves according to the sequence. The valve actuator selectively actuates a particular valve ata given time according to instructions from the controller.

The pump and the valve actuating mechanism may be powered through a coil inductively coupledtranscutaneously to an external power source, or by a battery

rechargeable through such coil and external power source According to one embodiment, a user positions and actuates the external power source to actuate the prosthesis. The electronics unit may be powered by a rechargeable or replaceable battery as the controller consumes relatively little power in its operation.

In another embodiment, the prosthesis is a prosthetic pyloric valve. According to this embodiment, a pyloric valve is replaced with a prosthesis comprising an outer member, an inner member and one or more sections of inflatable members between the outer and inner member. The inflatable member sections are selectively inflated and deflated to control the opening and closing of the pylorus. The prosthesis may include pressure sensors on opposite ends of the valve. The pressure sensors sense pressure in the stomach and duodenum and the opening and closing of the valve is adjusted accordingly. For example, a pressure increase from the duodenum would trigger the closure of the valve to prevent backflow of material into the stomach. An increasing pressure from the stomach may trigger a relaxing of the valve to permit materials to pass out of the stomach.

In another embodiment, the natural pyloric valve is augmented by implanting a pyloric prosthesis in the duodenum adjacent the pyloric valve. In this embodiment, the prosthesis may act to prevent material from passing into the small intestine even when the natural pyloric valve is open. Thus the augmented prosthetic pylorus may be used to retain food in the stomach for a greater length of time, e.g., to prevent gastric dumping or to treat obesity.

According to this embodiment, one or more inflatable members sections are provided between an inner member and an outer member. The outer member is sutured onto the inside of the duodenum intestinal wall, just below thepylorus. Inflation conduits extend from the expandable member out of the outer support member and intestine. The conduits are coupled to an implanted pump that inflates and deflates the inflation member sections as desired to retain or pass food.

Brief Description of the Drawings :

Figure1A is a side view of a prosthetic stomach device attached to a stomach according to an embodiment of the invention.

Figure 1B andIB-1 are schematic side views of the prosthesis of Figure 1A in a relaxed position, including a pump, valve actuating device and controller.

Figure1B-2 is an enlarged view of a portion of the prosthetic stomach of Figure 1B illustrating the wire sensors.

Figure 1C is a cross-section of Figure 1B along the linesIC-1C.

Figure 1D is a cross-section Figure 1B along the linesID-ID.

Figure1E is a schematic side view of the prosthesis of Figure1A a first actuated position.

Figure IF is a schematic side view of the prosthesis of Figure1A in another actuated position.

Figure 1G is a schematic side view of the prosthesis of Figure 1A in another actuated position.

Figure 1H is a schematic side view of the prosthesis of Figure 1A in another actuated position.

Figure1I is a schematic side view of the prosthesis of Figure 1A in another actuated position.

Figure 1J is a schematic side view of the prosthesis of Figure 1A in another actuated position.

Figure 2A is a side view of a prosthetic stomach device attached to a stomach according to an embodiment of the invention.

Figure 2B is a schematic side view of the prosthesis of Figure 2A in a relaxed position.

Figure 2C is a schematic side view of the prosthesis of Figure 2A in a closed position.

Figure 3A is a schematic side view of a prosthetic stomach device attached to a stomach according to another embodiment of the invention.

Figure 3B is a schematic side view of the prosthesis of Figure 3A in a relaxed position.

Figure 3C is a schematic side view of the prosthesis ofFigure 3A in a closed position.

Figure 4 is a schematic of a miniature valve-actuating device for controlling the valves of the pump of an embodiment of the invention in a first position with a valve closed and a . rotational position in which none of the openings of the device are aligned with a valve.

Figure 4A is an end view of the device as illustrated in Figure4 in the first position.

Figure 5 is a schematic of the valve-actuating device of Figure 4 in a second position.

Figure SA is an end view of the device illustrated in Figure 5 with the valve open and an inflation being inflated.

Figure 6 is a schematic of the micro valve-actuating device in the rotational position of Figure 5 with the valve closed and the inflation member in an inflated position.

Figure 6A is an end view of the device illustrated in Figure 6.

Figure 6B is a schematic side cross-section of the cylinder and rod of Figure 6.

Figure 6C is a cross section of Figure 6B along the lines 6B-6B.

Figure 6D is a cross section of Figure 6B along the lines 6D-6D.

Figure 6E is a top view of the cylinder of Figure 6.

Figure 6F is a cross section of a portion of the cylinder as illustrate in Figure 6E along the lines 6F-6F.

Detailed Description of the Invention:
Referring to Figure 1A, a prosthetic stomach 30 is illustrated attached to the upper portion 201 of the stomach 200 at the orad end portion33 of the prosthetic stomach 30 and to the duodenum202 at the aborad end portion 34 of the prosthetic stomach 30. An implantable pump'system 40 (Figure1B-1) and electronics unit 50 (Figure1B-1) are contained in a housing 80 coupled to the prosthetic stomach 30. The pump system 40 and electronics unit control the inflation and deflation of inflatable members 36a-g (Figure 1B) that are inflated and deflated according to a desired protocol, to actuate the stomach prosthesis 30. A bladder
49 of the pump system 40 is located externally of the housing, within the patient's soft tissue.

A schematic of the prosthesis of one embodiment is illustrated in Figures 1A-1J. The prosthesis includes a prosthetic stomach 30, a hermetically sealed pump system 40 and a hermetically sealed electronics unit 50 including a controller 51 for controlling the pump system 40. The pump system 40 and electronics unit 50 may be contained in the same housing 80 illustrated in Figure1A or may alternatively be separate.

The prosthetic stomach 30 includes an
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ti a ss table member sections36a-g, and an inner member32. The inflatable member sections 36a-g each . comprise a plurality of opposing inflatable members that when inflated act to close together and squeeze the inner member32. Each inflation member section 36a-f corresponds to a particular section a-f of the prosthetic stomach 30. In this particular embodiment, inflatable member sections 36a-d each comprise three inflatable members where the prosthetic stomach30 islarger (See Figure1C), and inflatable member sections 36e-g each comprise two inflatable members where the prosthetic stomach 30 is narrow (See Figure1D).

The outer support member 31 comprises a flexible, relatively inelastic material such as, for example, polyethylene or polyurethane, and provides structural support for the prosthetic stomach 30 (alternatively an elastic material may be used). The prosthesis sectionsa-f and inflatable member sections 36a-f form an antrum portion 37 of the stomach. Section g and inflatable member section 36g form a prosthetic pyloric valve38 at the aborad end portion 34 of the stomach prosthesis 30. The inner member 32 comprises a thin-walled, non- elastic flexible material such as polyethylene or polyurethane. The inside of the inner member 32 may be coated with an antibiotic surface, such as a silver coating, to reduce bacterial growth. The inner member 32 is attached to the outer support member31 at the orad end portion33 and the aborad end portion 34 of the prosthetic stomach 30 (for example, by welding) to provide an isolated cavity where material is mixed, broken down and passed through the pyloric valve 38. The orad end portion33 of the outer support member 31 includes an extended portion for suturing the outer support member31 to the upper portion of the stomach 201. The inflatable member sections36a-g are located between the outer support member31 and the inner member 32. The inner member 32 floats relatively loosely within the outer support member31 so as to permit movement including the inflation and deflation of the inflatable member sections 36a-g.

Although sections 36a-g are illustrated, the number of inflation member sections- depend on a selected prosthesis size, the size of the patient or the amount of the stomach to be replaced.

Each of the inflation members of a section converge together when inflated, to churn or move material in the prosthetic stomach 30. Each inflatable member section36a---r is coupled to and is in fluid communication with a corresponding one of conduits39a-g,

respectively. Conduits39a-g. are used to inflatable members36a-g by an implanted pump system 40.

As illustrated inFigure 1B, a controller 51 of an electronics unit 50 controls the implantable pump system 40 to. selectively inflate and deflate inflatable member sections 36a- g. The pump system 40 includes a bi-directional hydraulic pump 41 having an intake 47 coupled to a fluid reservoir 49 and an output 44 in fluid communication with a header45 having fluid ports45a-g. Thebi-directional pump 41 may be configured in a number of ways to provide pumping in two directions, for example, by controlling a series of valves that direct fluid into or out of the reservoir 49 or by providing a DC powered reversible pump.

The fluid reservoir 49 contains a sterile, radiopaque inflation medium sufficient to inflate two sections of inflation members36a-g or a combination thereof at a given time. The fluid reservoir 49 may be implanted at a location adjacent to or away from the pump system 40 (e.g. in soft tissue) or alternatively may be included with the pump system.

Each fluid port45a-g is coupled to a respective valve46a-g, which is coupled to a respective conduit39a-g. Each conduit39a-g is coupled to a corresponding inflation member pair36a-g. The valves46a-g are controlled by a valve actuating device 300 which operation is controlled by the controller 51 of the electronics unit50. The valves46a-g in this particular embodiment are controlled by a electromechanical device described in more detail with reference to Figures 4-6F. Alternative valve actuating mechanisms are also contemplated, for example, individually operated bistable solenoid valves may be used.

A pressure transducer 48 is located between the output 44 of the pump 41 and the header 45. The pressure transducer 48 senses the pressure of the fluid of a particular section of inflation members when the corresponding solenoid valve of the corresponding port is in an open position. The pressure transducer 48 is coupled to the controller51, which controls the pump 41 in response to a sensed pressure.

Sensors 53 and 54 are located on opposing ends of the inflation member section 36g (forming the pyloric valve38) between the outer support member31 and the inner member32. Sensor 54 is located on the antrum side while sensor 54 is location on the duodenum side. The sensors53, 54 are coupled to the electronics unit50 by leads. The sensors 53,54 are used to sense pressure on either side of thevalve 38. When the pressure increases or reaches a threshold level on the stomach side of the valve 38, the pyloric valve is relaxed by partially deflating the inflation member section

a threshold level on the duodenum side of the
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. 11, 11 g, l-.......... l 11...

-, is.. i. 7 lp'T & Vent backflow into the stomach. The pressure sensors53, 54 are coupled to a controller which can compare the pressures sensed by each of the sensors 53,54 and provide a control signal that will control the-resulting desired inflation or deflation of the valve 38 based on the sensed pressures or pressure differentials. The relative pressure on each side of the valve 38 as compared to the other side of the valve 38 may be used to control the valve 38 as well.

The electronics unit 50 includes a controller 51 and a battery52 powering the controller51. The controller 51 is programmed to control the action of the various elements of the prosthesis and to respond to various sensed conditions. The controller 51 is coupled to the pump system 40 and controls when and in which direction the pump 41 is actuated. The controller 51 is also coupled to a valve-actuating device 300 that opens and closes the valves46a-g according to a program stored in the controller51, thereby sequentially inflating and deflating inflation member sections36a-g. According to one embodiment, only one valve is open at a time. The controller 51 also includes a telemetry coil 59 for communicating information to and receiving information from an external device. The external device may be used to program operation parameters into the controller51. The external device may also receive signals from the controller 51 or electronics unit 50 representative of various sensed conditions, e.g., pressure or system leaks. The external device may program or reprogram the controller 51 based on sensed parameters or other patient conditions. An external device may also power the pump 41 and the valve-actuating device 300 through an electronics unit 70 comprising an electromagnetic coil 71 for inductively receiving power from an external source. The electromagnetic coil 71 is coupled to the electronics unit 50, which includes a voltage regulating circuit. The electronics unit 50 and controller 51 control the pump41'by powering the pump and controlling the valve actuating device 300. The voltage regulating circuit of the electronics unit 50 operates to convert a high frequency AC signal to a regulated voltage signal that powers the'pump 41 and valve actuating mechanism 300. Alternatively,- coil 59 may be used for both powering the pump and electronics unit 50 and for bi-directional telemetry communication.

The prosthetic stomach 30 also further includes wires55a-f (Figure1B-2) embedded in the prosthetic stomach 30 along its length and communicating with the electronic circuit50. The wires 55a and 55d are located in the outer tube 31 each between layers 31i and 31o and on opposing sides along the prosthetic stomach30. Wires 55b and 55e are exposed

between the inflation member pairs36a-e and [email protected] tube @@ on opposiring sides along the prosthetic bowel 30. Wires 55c and 55fare located in the inner tube 32 along the stomach 30between layer 32i and32o. Wire pairs 55a and 55d form an open circuit as do wire pairs 55b and 55e, and wire pairs 55c and55f. The electronic circuit50 is configured to sense a large drop in impedance in one or more of the pairs wires55a-f, where a fluid closes the circuit of one or more of the wire pairs indicating potential leakage of fluid into, out of or within the stomach 30, e.g from material external the prosthetic stomach 30, material within the inner member 32 of the stomach 30 or from an inflation member, or otherwise. In particular, a low impedance may be detected by the controller51, which is configured to sense impedance changes in the wires55a-f. The impedance of the pairs of wires55a-f is periodically monitored by the controller51. If a leak is detected a patient alarm may be triggered, e. g. , by telemetrically delivering an alarm signal from the electronics unit 50 to an external device.

Furthermore, the location or cause of the leak may be determined by which wires55a-f have changed impedances. The wire pairs may be placed in different configurations within layers31 i, 31 O, 32i, 32O or between the inner 32 and outer members31, for example, they may be is parallel spiraled configurations to maximize the sensing of potential leaks.

The prosthetic stomach 30 also includes a conduit 56 through the prosthetic bowel 30, into a port57 inside the inner member 32 for delivery a digestive enzyme, antibiotic material, or the like from a reservoir 58. The reservoir 58 is coupled to the controller 51 and may include a pump controlled by the controller 51 that provides a periodic or otherwise actuated (e. g. by a patient) injection of a material into the inner member 32. The reservoir58 may also be implanted in soft tissue or may be included with the housing180.

The prosthetic stomach 30 is illustrated in Figure 1B in an inactive position in which a patient may ingest food and food may move from the fundus into the antrum portion 37 of the prosthetic stomach30. In this position the pyloric valve 38 at the aborad end portion 34 is in a closed position with inflation member section36g inflated. The inflation member sections36a-f of the antrum portion 37 are relaxed and deflated.

Figures lE-1J illustrate a sequence of mixing food and emptying the prosthetic stomach 30 of one embodiment of the invention. In Figure1E the valve 46a is opened and the pump 41 pumps inflation medium from the reservoir 49 into the inflation member section36a through the conduit 39a. The inflation member section 36a is inflated to a predetermined pressure as sensed by pressure transducer 48 or alternatively as sensed by the motor. Once

the inflation member section 36a is inflated, the mechanism 60 (Figure1 B). Inflation of the inflation member section 36a closes the orad end portion

stomach 30 and the sequence of inflating and
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deflamthje- [. jnam. ba. ijs pip ; until the last inflation member sections 36e and 36f are inflated as illustrated in Figure1J.

If the materials have not been sufficiently broken down to pass through the pyloric valve38 the mixing cycle may be repeated until they are sufficiently broken down.

Figures 4-6F illustrate a valve-actuating device 300 according to an embodiment of the invention. The valve-actuating device 300 comprises a cylinder 310 having a length Lc aligned parallel with the length Lh of the header 45 of the pump 41 and adjacent the valves46a-g. The cylinder 310 includes a plurality ofopenings 320a-g, spaced a defined distance along the length Lc of the cylinder310 with respect to the other openings so that each opening is aligned lengthwise with a corresponding one of the valves46a-g. Each opening 320a-g is also spaced a defined discrete distance circumferentially from the other openings.

The cylinder310 is coupled to a stepper motor330 that rotates the cylinder 310 according to instructions from the controller 51 (Figure 1A) into discrete circumferential positions tointerfacingly align a selected opening with a corresponding selected valve. Thus, the cylinder
310 may be rotated to discrete positions wherein in each position one of the openings320a-g is interfacing a corresponding one of the valves46a-g to be actuated.

A valve is actuated by a peg extending out of an interfacing opening in the cylinder
310 to engage and move the valve into an open position. Each opening 320a-g in the cylinder
310 includes concentrically moveable peg 321a-g respectively. Each of the pegs321a-g is capable of being partially advanced in a circumferential direction out of the corresponding opening 320a-g in the cylinder 310. When interfacing with a corresponding valve 46a-g, a correspondingpeg 321 a-g may be advanced to engage and open the corresponding valve 46a-g to open it.

Once a valve is selected and the controller 51 instructs the stepper motor 330 to rotatably position the cylinder310 accordingly, an actuating rod 323 is advanced through the cylinder310 to engage and advance the corresponding aligned, interfacing peg out of the cylinder 310 to open the corresponding valve.

The actuating rod323 slidably extends axially through an axial opening313 in the cylinder310. The rod323 is coupled to a solenoid 328 that moves the rod 323 between two positions: a first resting position (Figure 4-4A, Figures 6-6F) and a second valve actuating position (Figure5-5A). The solenoid328 advances and retracts therod 323 to and from a valve actuating position. The actuating rod 323 moves in a direction generally perpendicular

to the circumferential sliding direction of the pegs
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, 4"11,", I,"11 11't. I ;, ' ! central rod 324 and a pluralityof staggered fins 325a-g having cammed surfaces 326a-g. In the first position, the fins325a-g are staggered in a lengthwise relationship between the valves46a-g and a second position, the fins325a-g are generally aligned in a lengthwise relationship with the valves46a-g. The cammed surfaces326a-g are arranged so that when the rod323 is advanced to the second position, a corresponding one of the cammed surfaces326a-g will engage a corresponding one of the pegs321a-g to move the corresponding one of the pegs321 a-g circumferentially out of a corresponding one of the openings320a-g.

The axial opening 313 through the cylinder 310 includes a central rod portion 314 for receiving the rod323 and a fin portion 315 for receiving in thefins 325a-g. The central rod portion 314 extends axially through the cylinder 310. The fin portion 315 of the axial opening 313 includes open portions316a-g staggered in a lengthwise relationship between the valves46a-g. Each open portion316a-g is open within the rod opening 313 about the circumference of the cylinder 310 so that when the rod323 is in the first position, the cylinder
310 is free to rotate without interference of the fins 325a-g. The fin portion315 also includes a plurality of slits317a-g circumferentially spaced from the other slits, wherein each slit extends longitudinally through the cylinder, between each of the open portions316a-g and perpendicularly through a corresponding one of theopenings 320a-g.

The fins325a-g are aligned in a position with the circumferentially extending top portions facing the header45. The cylinder310 may be rotated when the rod 323 and fins are in the first position. The cylinder when rotated to one of its discrete positions aligns a corresponding slit with the fins so that in the second position the fins advance through that slit. When the fins325a-g are moved into the second position, the fins 325a-g extend through the slit corresponding to the opening that is positioned in alignment with a corresponding valve. In each discrete position the fins325a-g are aligned with a slit permitting the corresponding fin to slide into the opening and engage the pin moving the pin out of the opening engaging the correspond valve with which it is aligned, thus actuating the corresponding valve. Each peg321a-g is biased by a corresponding spring (329a only is shown) into a position circumferentially into the opening so that when the fins are retracted(e.g. Figure 6), the pin moves back into the opening.

The controller 51 controls the timing and actuation of the cylinder310 rotation and the solenoid 328 positioning. Referring to Figure 4, the cylinder 310 is rotated to a position

in which none of the pegs are aligned with valve36al.. he rod is in a first position in which the cylinder310 may rotate freely. The cylinder 310 is then rotated as illustrated in Figure5 so that the opening321a is aligned with the valve46a. The rod 323 is advanced so that the fins 325a-g extend through the slit 317a. Fin 325a extends into the opening 320a that is. aligned with theslit 325a and the cammed surface 326a of the fin 325a engages thepeg 32 la and advances it out of the opening 320a to actuate valve46a. The valve 46a is opened and the pump 41 pumps fluid from the reservoir 49 into the inflatable member pair 36a. As illustrated in Figure 6, the rod323 is then retracted releasing thepeg 321a, which is biased by spring329a into the cylinder opening 320a, and the valve 46a is closed, leaving the inflation member pair 36a inflated.

Referring to Figures 2A-2C another embodiment of the invention is illustrated. A prosthesis includes a prosthetic pylorus130 and a housing 180 containing a pump system similar to the pump system 40 described above with reference to FiguresIA-1J. The prosthetic pylorus 130 includes an outer support member131, a series of inflatable member sections136a-b and an inner member 132. The outer support member 131 comprises a flexible, relatively inelastic material such as, for example, polyethylene or polyurethane, and provides structural support for the pylorus (elastic materials may be used as well. ). The inner member132 comprises a thin-walled, non-elastic flexible material such as polyethylene or polyurethane. The inner member132 may be coated with an antibiotic surface, such as a silver coating, to reduce bacterial growth. The inner member 132 is attached to the outer support member131 at the orad end portion133 and the aborad end portion 134 of the prosthetic pylorus 130 (for example, by welding) to provide an isolated conduit through which material may pass. The orad end portion133 and aborad end portion 134 of the outer support member131 include relatively thicker portions forsuturing the orad end portion133 of the outer support member 131 to the stomach 100 and aborad end portion 134 of the outer support member131 to the small intestine101 as shown in Figure 2A. The inner member
132 defines a conduit through which material pass from the stomach 100 into the small intestine 101. The inflatable member sections 136a-b are located between the outer support member131 and the inner member 132 with the inner member132 floating relatively loosely within the outer support member131 so as to permit the inflatable member sections136a-b to expand and contract.

The prosthesis1-50 is iniplanted to replace
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p. vlrrp6lSqff,., tE ; st. ThelirMatable . FpW : :. a : :. fi. . ~ ~ :.. : ~ :... member sections136a-b and the inner member 132 form a valve138. The inflatable members 136a-b are attached to the inside of the outer support member 131 between the outer support member 131 and the inner member 132 along the length of the prosthesis130..

According to this embodiment, the inflatable member section136a forms an orad inflatable member pair and the inflatable member section136b forms an aborad inflatable member pair.

Each section of inflatable members converges together when inflated, to close the valve138.

The valve138 is actuated by inflating sections136a-b, which causes the inner member132 to squeeze together to seal the conduit closed.

Each section136a-b is coupled to and is fluid communication with a corresponding respective one of conduits 139a,139b. Conduits 139a, 139b are used to selectively deliver inflation medium to and from sections136a-b by an implanted pump system 140 (and valve actuator) and electronics unit 150 similar to the pump system40 (and valve actuator 300) and electronics unit 50 described above with reference to FigureslA-1J and Figures 4-6F.

Referring now to Figures 3A-3C, a supplemental pyloric valve 230 is illustrated implanted adjacent a pylorus 205 and in the duodenum 206. The supplemental pyloric valve
230 is coupled to an implanted housing280 including a hermetically sealed pump 241 and controller 251 operating in a similar manner as pump system 40 (and valve actuator 300) and electronics unit 50 described above with reference to Figures1A-J and Figures 4-6F
The supplemental pylorus230 includes an outer support member231, a series of inflatable members sections236a-b and an inner member 232. The outer support member231 comprises a flexible, relatively inelastic material such as, for example, polyethylene or polyurethane, and provides structural support for the pylorus (elastic materials may be used as well). The inner member 232 comprises a thin-walled, non-elastic flexible material such as polyethylene or polyurethane. The inner member 232 may be coated with an antibiotic surface, such as a silver coating, to reduce bacterial growth. The inner member 232 is attached to the outer support member 231 at the orad end portion233 and the aborad end portion 234 of the supplemental pyloric valve230 (for example, by welding) to provide an isolated conduit through which material may pass. The orad end portion233 of the support member231 is sutured on to the inner wall207 of the duodenum adjacent the pylorus 205.

The aborad end portion 234 of the outer support member231 is sutured to duodenum 206 downstream of the orad end portion as shown in Figure3A. The inner member232 defines a

conduit through which material pass from the pylorus 205 into the small intestine 206. The inflatablemember sections 236a-b are located between the outer support member231 and the inner member232 with the inner member232 floating relatively loosely within the outer support member231 so as to permit the inflatable member sections 236a-b to expand and contract.

The supplemental pyloric valve230 is implanted to supplement the pylorus of the stomach by further controlling the exit of material from the stomach through the pylorus and into the duodenum. In one embodiment this is done to retain food in the stomach for a greater duration to treat obesity and/or dumping syndrome. The inflatable member sections 236a-b and the inner member232 form a valve238. The inflatable members236a-b are attached to the inside of the outer support member 231 between the outer support member 231 and the inner member 232 along the length of the prosthesis 230. According to this embodiment, the inflatable member section236a forms an orad inflatable member pair and the inflatable member section236b forms an aborad inflatable member pair. Each pair of inflatable members converges together when inflated, to close the valve238. The valve238 is actuated by inflating sections236a-b, which causes the inner member232 to squeeze together to seal the conduit closed.

Each section236a-b is coupled to and is fluid communication with a corresponding respective one of conduits239a, 239b. Conduits239a, 239b extend out of the duodenum and are coupled to the pump241. Conduits 239a, 239b are used to selectively deliver inflation medium to and from sections236a-b by an implanted pump and control controller similar to the pump system 40 and electronics unit 50 described above with reference to Figures 1A-1J and Figures 4-6F.

While the invention has been described with reference to particular embodiments, it will be understood to one skilled in the art that variations and modifications may be made in form and detail without departing from the spirit and scope of the invention.

For example, the invention may be practiced replacing or augmenting all or part of a portion of the digestive tract such as the bowel or small intestine as described, for example in
U. S. applicationentitled"INIPLANTABLE DIGESTIVE TRACTORGAN"filed on even date herewith, incorporated herein by reference.

What is claimed is:

1. An implantable prosthetic digestive organ for moving materials through a portion of the digestive tract comprising : a prosthetic pyloric valve comprising : an outer support structure; at least one expandable member located within the outer support structure; a flexible inner member forming a conduit for the movement of material there through, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner. member and the outer support structure.

2. The implantable prosthetic organ of claim 1 wherein the prosthetic pyloric valve further comprises an orad end portion, an aborad end portion, and a sensor located at the aborad end portion arranged to sense pressure in the duodenum, wherein the prosthetic pyloric valve further comprises a controller configured to receive a signal from the sensor corresponding to a sensed pressure in the duodenum and to generate a control signal responsive to the sensed pressure to control the inflation/deflation of the at least one expandable member.

3. The implantable prosthetic organ of claim 2 wherein the prosthetic pyloric valve further comprises an orad end portion, an aborad end portion, and a sensor located at the orad end portion arranged to sense pressure in the stomach, wherein the prosthetic pyloric valve further comprises a controller configured to receive a signal from the sensor corresponding to a sensed pressure in the stomach and to generate a control signal responsive to the sensed pressure to control the inflation/deflation of the at least one expandable member
4. The implantable prosthetic organ of claim 1 further comprising a pump system comprising a pump wherein the at least one expandable member further comprises an input port coupled to the pump, and wherein the implantable pump is configured to pump an inflation medium into the at

least one expandable member through acorresponqin,,, : Ii expandable member.

5. The implantable prosthetic organ of claim 4 wherein the pump system is implantable.

6. The implantable prosthetic organ of claim 4 further comprising a controller operatively coupled to the pump system configured to control inflation and deflation of the at least one expandable member.

7. The implantable prosthetic organ of claim 1 wherein the pyloric valve is configured to replace a recipient's natural pylorus.

8. The implantable prosthetic organ of claim 1 wherein the outer support structure is configured to be attached to the inner wall of the duodenum.

9. The implantable prosthetic organ of claim 1 wherein the at least one expandable member comprises a plurality of expandable members.

10. An implantable prosthetic stomach comprising : an outer support structure; at least one expandable member located within the outer support structure; a flexible inner member forming a cavity for the churning of material therein, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure.

11. The implantable prosthetic stomach of claim 10 wherein the stomach comprises : an antrum portion having an orad end portion for receiving ingested materials and a aborad end portion coupled to a pylorus, the antrum portion comprising a plurality of expandable members located between the outer support structure and the inner member, wherein the expandable members arc configured expand and deflate in a sequence to churn the ingested material.

12. The implantable prosthetic stomach of claim 11 further comprising a controlller configured to control expansion and deflation of the expandable members according to the sequence.

13. The implantable prosthetic stomach of claim 11 wherein the pylorus is a prosthetic pyloric valve comprising at least one expandable member located between the outer support member and the inner member, wherein the at least one expandable member is configured to be inflated to tighten the pyloric valve and deflated to relax the pyloric valve.

14. The implantable prosthetic stomach of claim 11 further comprising an implantable pump system including a pump wherein the at least one expandable member further comprises an input port coupled to the pump, and wherein the implantable pump is configured to pump an inflation medium into each of the expandable members through a corresponding input port to expand the at least one expandable member.

15. The implantable prosthetic organ of claim 14 further comprising a controller operatively coupled to the pump system configured to control inflation and deflation of the at least one expandable member.

16. The implantable prosthetic organ of claim13 wherein the prosthetic pyloric valve further comprises an orad end portion, an aborad end portion, and a sensor located at the aborad end portion arranged to sense pressure in the duodenum, wherein the prosthetic pyloric valve further comprises a controller configured toreceive a signal from the sensor corresponding to a sensed pressure in the duodenum andto- generate a control signal responsive to the sensed pressure to control the inflation/deflation of the at least one expandable member.

17. The implantable prosthetic organ of claim 13 wherein the prosthetic pyloric valve further comprises an orad end portion, an aborad end portion, and a sensor located at the orad end portion arranged to sense pressure in the stomach,

wherein the prosthetic pyloric valve
EMI21.1
furthe. s. e 1 . gj. . receive a signal from the sensor corresponding to a sensed pressure in the stomach and to generate a control signal responsive to the sensed pressure to control theinflation/deflation of the at least one expandable member.

18. An implantable prosthetic digestive organ for moving materials through a portion of the digestive tract comprising : a prosthetic pyloric valve means for controlling the passage of material between a stomach and small intestine of a recipient: an outer support means for supporting the prosthetic organ ; expandable means for controlling the tightening and relaxing of the valve means; and a flexible inner member means for providing a conduit for the movement of material therethrough, the flexible inner member means located within the outer member, wherein the expandable means is located between the inner member means and the outer support means.

19. The implantable prosthetic digestive organ of claim 18 sensor means for sensing a the pressure in the duodenum; and controller means for receiving a signal from the sensor means corresponding to a sensed pressure in the duodenum and generating a control signal responsive to the sensed pressure to control the inflation/deflation of the expandable means.

20. The implantable prosthetic digestive organ of claim IS sensor means for sensing a the pressure in the stomach; and controller means for receiving a signal from the sensor means corresponding to a sensed pressure in the duodenum and generating a control signal responsive to the sensed pressure to control theinflation/deflation of the expandable means.

21. The implantable prosthetic organ of claim IS further comprising a pump system means for pumping an inflation medium into the expandable means through a to expand the expandable means.

22. The implantable prosthetic organ of claim 18 wherein the prosthetic pyloric valve means

is a means for replacing a recipient's naturalpylorus,23. The implantable prosthetic organ of claim 18 wherein the prosthetic pyloric valve means is a means for augmenting a recipient's natural pylorus to further control the passage of food from the stomach into the small intestine of the recipient.

24. An implantable prosthetic stomach comprising : antrum means for churning and moving material within the prosthetic stomach, the antrum means comprising : outer support means for supporting the prosthetic stomach; expandable means expandable means for expanding and contracting to churn and move food inner means for providing a cavity for the churning of material therein inner means located within the outer support means, wherein the expandable means is located between the inner means and the outer support means.

25. The implantable prosthetic stomach of claim 24 further comprising a controller means for controlling expansion and deflation of the expandable means according to a sequence.

26. The implantable prosthetic stomach of claim 24 further comprising a pylorus means for controlling movement of material from a stomach to a small intestine of a recipient, the pylorus means comprising expandable valve means for inflating to tighten the pylorus means and deflating to relax the pylorus means, the expandable valve means located between the outer support means and the inner means.

27. The implantable prosthetic stomach of claim24 further comprising a pump system means for pumping an inflation medium into the expandable means through a to expand the expandable means.

2S. The implantable prosthetic stomach of claim24 further comprising controller means for controlling inflation and deflation of the expandable means, wherein the controller means is operatively coupled to the pump system means.

29. The implantable prosthetic stomach of claim 24 further comprising sensor means for sensing a the pressure in the duodenum; and controller means for receiving a signal from the sensor means corresponding to a sensed pressure in the duodenum and generating a control signal responsive to the sensed pressure to control the inflation/deflation of the expandable means.

30. The implantable prosthetic stomach of claim 24 sensor means for sensing a the pressure in the stomach; and controller means for receiving a signal from the sensor means corresponding to a sensed pressure in the duodenum and generating a control signal responsive to the sensed pressure to control the inflation/deflation of the expandable means.

31. A method for controlling the movement of material from a stomach to a small intestine comprising the steps of : providing a prosthetic pyloric valve; attaching the prosthetic pyloric valve between the stomach and a location in the small intestine; tightening the prosthetic pyloric valve; and relaxing the prosthetic valve according to a desired protocol to control the movement of material from a stomach to a small intestine.

32. The method for controlling the movement of material from a stomach to a small intestine of claim31 wherein the step of providing a prosthetic pyloric valve comprises providing : an outer support structure; at least one expandable member located within the outer support structure; and a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure, wherein the step of tightening the valve comprises inflating at least in part, the at least one expandable member, and wherein the step of relaxing the valve comprises deflating at least in part, the at least

one expandable member.

33. A method for treating obesity comprising the steps of: providing a prosthetic pyloric valve; attaching the prosthetic pyloric valve between a stomach and a location in the small intestine ; tightening the prosthetic pyloric valve to retain material in the stomach for a desired duration; and relaxing the prosthetic valve according to a desired protocol to permit the movement of material from the stomach to the small intestine.

34. The method for treating obesity of claim 34 wherein the step of providing a prosthetic pyloric valve comprises providing : an outer support structure; at least one expandable member located within the outer support structure; and a flexible inner member forming a conduit for the movement of material therethrough, the flexible inner member located within the outer member, wherein the least one expandable member is located between the inner member and the outer support structure, wherein the step of tightening the valve comprises inflating at least in part, the at least one expandable member, and wherein the step of relaxing the valve comprises deflating at least in part, the at least one expandable member.

The invention relates in an implantable prosthesis surgically replacing or segmentinfg all or part of the
antern and/or pylorus of a suitable. The prosthsis Controls the passage of food from the stomach to the small intensine. The
prosthesis may be configured to churn ingested material and release; it from the stomach through a prosthesis pyloric valve. At least
one expandable member is an anged in be expanded 10 control the passage of food and/or to mimic the churning action of a patienti
stomach. The prosthesis includes outer support structure, a flexible inner member forming a conduit for the movement of material,
and at least one expandable member located between the outer support structure and inner member. An Implantable pump system is
provided for inflating and deflating the expandable member(s).

Documents:

01441-kolnp-2005-abstract.pdf

01441-kolnp-2005-claims.pdf

01441-kolnp-2005-description complete.pdf

01441-kolnp-2005-drawings.pdf

01441-kolnp-2005-form 1.pdf

01441-kolnp-2005-form 2.pdf

01441-kolnp-2005-form 3.pdf

01441-kolnp-2005-form 5.pdf

01441-kolnp-2005-international publication.pdf

1441-KOLNP-2005-FORM-27.pdf

abstract-01441-kolnp-2005.jpg


Patent Number 240614
Indian Patent Application Number 1441/KOLNP/2005
PG Journal Number 21/2010
Publication Date 21-May-2010
Grant Date 19-May-2010
Date of Filing 25-Jul-2005
Name of Patentee PYTHON, INC.
Applicant Address 1390 WILLOW ROAD, MENLO PARK, CA 94025, U.S.A.
Inventors:
# Inventor's Name Inventor's Address
1 IMRAN, MIR, A. 1390 WILLOW ROAD, MENLO PARK, CA 94025, U.S.A.
PCT International Classification Number A61F
PCT International Application Number PCT/US2003/041305
PCT International Filing date 2003-12-22
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 10/328,248 2002-12-23 U.S.A.