AU2020227101B2

AU2020227101B2 - An Apparatus for Treating Gerd

Info

Publication number: AU2020227101B2
Application number: AU2020227101A
Authority: AU
Inventors: Peter Forsell
Original assignee: Implantica Patent Ltd
Current assignee: Implantica Patent Ltd
Priority date: 2009-01-29
Filing date: 2020-09-04
Publication date: 2021-12-02
Anticipated expiration: 2030-01-29
Also published as: AU2018267675A1; AU2016247188B2; AU2022201455A1; AU2018267675B2; AU2016247188A1; AU2020227101A1; BRPI1007498A2; AU2022201455B2; BRPI1007498B1

Abstract

The present invention relates to a reflux disease treatment apparatus, comprising two or more movement restriction device segments adapted to form an implantable movement restriction device with an elongated shape that maintains cardia in the correct position. The movement restriction device has proximal and a distal end, wherein the distal end is adapted to stabilize and hold the proximal end. The invention further comprises a control device for controlling the stimulation device to stimulate the cardia sphincter. The distal end can be further adapted to treat obesity, for example by stretching the wall of the stomach or filling out a volume of the stomach. 31/93 Fig.49a 14c 14 Fig.49b Fig.49c

Description

31/93

Fig.49a

14c

14

Fig.49b Fig.49c

AN APPAIRAUJS FOR']RFA'ING GERD

'Ichnical field

[0001] The present invention plates to an apparatus for tmaing Gastro Esophageal Rieflux Disease (GERD).

[0002] The present invention plates to a reflux disease tmatment apparatus, comprising an implantable elongated movement estriction device having a proximal part that maintains the cardia in the comectposiion and a distal part that stabilizes the proximal part and is adaptable to additional tmat obesity. The apparatus may further comprise an implantable stimulation device adapted to engage with the cardia sphincter of a patient and a contml device for controlling the stimulation device to stimulate the cardia sphincter. The invention can be further combined with various methods for treating obesity, in particular methods that crates satiety by stretching the wall of the stomach or fills out a volume of the stomach

Background art

[0003] Gastro esophageal Rieflux Disease (GERD), or acid rflux disease, is a chronic condition rsulting in mucosal damage in the esophagus produced by the rcuning occurrence of acid rflux in the esophagus. Ihisiscommonlydueto transient or permanent changes in the barrier between the esophagus and the stomach Ihis can be due to incompetence of the lower esophageal sphincter (IS), transient I relaxation, impaired expulsion of gastric reflux fim the esophagus, or a hiatal hernia.

[0004] Gastro esophageal Rieflux Disease can be tmated in a number of differntways. 'leatments include, but ar notlimited to, both medical and surgical tmatments. A standard surgical tmatment which sometimes is prfered over longtime use of medication, is Nissen fundoplication surgery, in which the upper curve of the stomach (the fundus) is wrapped around the IES to strngthen the sphincter and pmvent acid rflux and to pair a hiatal hernia. 'The procedum is often done laparoscopically.

[0005] Another surgical tmatment which has been used is the Anglechik prosthesis, in which a device formed like a horseshoe is placed around the esophagus above the cardia. The intended effectis to preventthe cardia fiom slipping up into the thorax cavity. However, this device has a number of complications, including migrating through and damaging the esophagus.

[0006] Rom experience with implantation of medical devices, itis known that sutums between an implanted device and human tissue will not hold over the long term. Fbr long term implantation of a device, there am two possibilities to keep the device in place. A fist solution has been to sutur human tissue to human tissue, to therby keep the device in place. A second approach has been to provide sutures holding a device in place in the short term and to allow in-growth of human tissue into the device for holding the device in place over the long term.

[0007] A problem with providing an implantable device associated with the esophagus is that the outer surface of the esophagus is only comprised of esophagus muscle tissue, which is very easy to damage or migrate through his is probably one reason why the Anglechik prosthesis described above hasrsulted in many complications, such as migration

[0008] The stomach, on the other hand, has a serosa on its outside, therby providing a much stronger membrane for suturing. hus, suturing a device directly to the stomach wall provides a better msult than suturing an implanted device to the esophagus.

[0009] Today, there exists a need for a long term treatment of GERD that is more effective than prior treatments and which does not result in any severe complications.

[0009a] Each document, reference, patent application or patent cited in this text is expressly incorporated herein in their entirety by reference, which means that it should be read and considered by the reader as part of this text. That the document, reference, patent application or patent cited in this text is not repeated in this text is merely for reasons of conciseness.

[0009b] Throughout the specification, unless the context requires otherwise, the word ''comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not he exclusion of any other integer or group of integers. Furthermore, throughout the specification, unless the context requires otherwise, the word "include" or variations such as "includes" or "including", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

Summary of invention

[0010] It is an object of the present invention to overcome, or at least reduce, some of the problems associated with existing surgical treatments of Gastro Esophageal Reflux Disease (GERD). It is another object of the present invention to provide an apparatus for treating Gastro Esophageal Reflux Disease. These objects and others are obtained by the apparatus described in the appended claims.

[0011] An object of the present invention is to provide reflux disease treatment apparatus with improved long term properties which also can be additionally provided with obesity treatment functions.

[0012] This object and others are obtained by an apparatus described in the appended claims. In general terms, the present invention relates to an apparatus for treating reflux disease in a human or animal mammal patient comprising two or more movement restriction device segments to form an implantable movement restriction device having an outer surface with an elongated shape adapted to be at least partly be invaginated by a stomach wall portion of a patient. The movement restriction device has, when implanted in a patient, a proximal part and a distal part, and the device is adapted to rest at least partially with the outer surface of its proximal part against the patient's stomach fundus wall, in a position between the patient's diaphragm and the fundus wall, such that movement of the cardiac notch of the patient's stomach towards the patients diaphragm is restricted, when the movement restriction device is implanted in the patient, to thereby prevent the cardia from sliding through the patients diaphragm opening into the patients thorax, so as to maintain the supporting pressure against the patients cardia sphincter muscle exerted from the patient's abdomen. The device is also adapted to stabilize and hold the proximal part by the distal part adapted to be substantially invaginated in the stomach wall in order to prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax. The terms "proximal" and "distal" have the usual anatomical meaning.

Accordingly, proximal as an anatomical position means nearest the center of the body, or at

the beginning of a structure. In the present context proximal and distal refer to parts of the

movement restriction in its implanted position. The length of the distal invaginated part of

the elongated movement restriction device is sufficiently long to stabilize the proximal part

of the elongated movement restriction device to prevent the cardia from sliding through the

patient's diaphragm opening into the patient's thorax. The circumference of the distal

invaginated part of the elongated movement restriction device is such that it is stabilizing

the proximal part of the elongated movement restriction device to prevent the cardia from

sliding through the patient's diaphragm opening into the patient's thorax. The proximal part

of the movement restriction device has a size of at least 125 mm3 and a circumference of at

least 15 mm.

4a

[0012a] In accordance with as aspect of the invention, there is provided an intraluminar method of treating a reflux disease in a patient by implanting a device comprising an implantable movement restriction device that, when implanted in a patient, restricts the movement of the cardiac notch in relation to the diaphragm muscle, preventing the cardia from sliding through the esophageal hiatus, the implantable movement restriction device comprising at least two segments, the intraluminar method comprising introducing an instrument through the esophagus and into the stomach of the patient, introducing the implantable movement restriction device through the esophagus using said instrument, invaginating the implantable movement restriction device by a portion of the fundus wall, such that an outer surface of the movement restriction device rests against a surface of the fundus wall and affixing the invaginated movement restriction device to the fundus wall, thereby preventing the cardia from sliding through the esophageal hiatus and thus reducing reflux disease.

[0013] Preferably, the apparatus comprises an implantable first fixation device

that secures the proximal part of the movement restriction device in a position that restricts

the movement of the cardiac notch of the stomach towards the patients diaphragm, with the

outer surface of the movement restriction device substantially contacting the patient's

stomach fundus wall. The first fixation device may include sutures or staples that attach

together portions of the fundus stomach wall that enclose the proximal part of the

movement restriction device to secure the movement restriction device in said position, i.e.,

the movement restriction device is at least partly placed in an invaginated space. Thus, by

affixing the proximal part of the implantable movement restriction device indirectly in this

manner, no suturing between the movement restriction device and tissue is required, which,

in turn, further reduces the risk for complications. Keeping the proximal part of the movement restriction device in place in this manner has rsulted in an elastic suspension with improved long term properties.

[0014] The fist fixation device, such as sutures or staples, attach together portions of the fundus stomach wall so at to invaginate the proximal part of the movement restriction device fim either inside or outside of the patient's stomach wall.

[0015] Altematively, a tissue growth promoting structum may be sutmd to the stomach wall with a relatively large contact surface towards the stomach The relatively large surface of the structum, such as a net will allow for in-growth of human tissue for holding the proximal part of the movement estriction device in place over the long term.The tissue growth promoting structum may comprise suturs or staples that attach the net like structum to the fundus stomach wall.

[0016] In addition to affixing the proximal part of the movementrestriction device to the stomach wall a second fixation device may be employed. The second fixation device can be used to affix the proximal part of movementrestriction device in rlation to the cardia. Fbr example, the proximal part of the movementrestriction device can be affixed in a position above the cardia, between the cardia and the diaphragm muscle, by a second dimct or indimect affixation of the proximal part of the movement restriction device via the fundus stomach wall. The second fixation device may secue, indimnecty or direcy, the proximal part of the movement restriction device to the esophagus close to the patients angle ofHis. The second fixation device suitably includes a plurality of suturs or staples that attach the fundus wall and a wall of the patients esophagus to hold the movementrestriction device in said position

[0017] The apparatus may also comprise a third fixation device that secumes, indirectly or dircy, the proximal part of the movement restriction device to the patient's diaphragm muscle or other muscle tissue. The third fixation device suitably comprises a plurality of suturs or staples that attach the fundus wall and the diaphragm muscle or other muscle tissue to hold the movement restriction device in said position

[0018] The proximal partof the movement estriction device may be adapted to be substantially or completely invaginated by the patient's stomach fundus wall, and be placed either on the inside or outside of the stomach fundus wall.

[0019] The proximal part of the movement estriction device may be adapted to be placed on the outside of the patient's stomach wall, such that the stomach cavity is substantially educed, by a volume substantially exceeding the volume of the movement estriction device.

[0020] At least a part of the proximal part of the movement estriction device may be made of a material which is destructible or not destructible by stomach acid.

[0021] In an embodiment, the proximal part of the movement estriction device is inflatable and adapted to be inflated with a gel or fluid. A fluid or gel receiving member for rceiving fluid to inflate the movement estriction device may be provided.

[0022] The proximal part of the movement estriction device may include a homogenous material and may be a solid body.

[0023] The proximal part of the movementrestriction device may include an enclosure wall defining a chamber.

[0024] The proximal part of the movement estriction device may have a rigid, elastic or flexible outer wall. Where the outer wall is rigid, it is rigid enough to maintain non-deformed when subject to foes created by stomach movements.

[0025] In accordance with a prfered embodiment of the apparatus, the proximalpart of the movementrstriction device comprises a body adapted to beat least partly invaginated by the patient's stomach fundus wall and having an outer surface that includes a biocompatible material. A substantial part of the outer surface of the body is adapted to rst against the stomach wall in said position between the patient's diaphragm and the portion of the lower part of the invaginated stomach fundus wall. Suitably, the body is made of a material softer than25 or 15 Shore.

[0026] In accordance with a fist general design of the body, the body has a maximum circumfernce as seen in a plane perpendicular to an axis though the body. The circumfernces of the body as seen in other planes perpendicular to said axis am equal to the maximum circumfernce or decrease as seen along said axis in the direction fim the maximum cirumference. Fbr example, the body may be substantially egg shaped, spherically shaped, or substantially shaped like an egg with an indented middle section or like a bent egg.

[0027] In accordance with a second general design of the body, the cimrumfernce of the body as seen in a plane perpendicular to an axis though the body increases and decreases atleasttwo times as the plane is displaced along said axis, or decreases and increases atleastone time as the plane is displaced along said axis. Fbr example, the body may be substantially shaped like akidney.

[0028] referably, the body is dimensioned with a size larger than the intestinal outlet fim the stomach The body may have a smallest outer diameter of or 40 mm or larger and may have a smallest outer cirumference of 150, 110, , 70, 50 or 30mm.

[0029] Suitably, the body has rounded contous withouttoo sharp edges that would be damaging to the patient s stomach wall, and has a generally smooth outer surface for resting against the fundus wall.

[0030] The body is implantable either inside or outside of the patient s stomach and is adapted to be attached to the patient s stomach wall by surgery. The body may be changeable to assume a slender formhaving a smaller diameter than that of a rocar for laparoscopic use, whermby the body when changed to said slender form can be pushed or pulled though the rocar. The body may include a flexible outer wall defining a chamber filled with a fluid, such as a gel, allowing the body to pass through such a tocar. Alternatively, the body may include an elastic compressible material, allowing the body to pass through a rocar.

[0031] The body may be hollow and include atleast two separate pieces adapted to be inserted into the hollow body, and further adapted to be put together to one unitay piece inside the body, therby allowing the body to pass through a frocar for laparoscopic use. Alternatively, the body may include an outer wall and a hollow compressed inner part, for being filled with a fluid or gel after insertion into the patient s body.

[0032] The body may include a chamber with an injection port, wherein the chamber of the body is filled with a fluidthough the injection port.

[0033] The body may include atleast one holding device adapted to be used for pushing or pulling the body through a rocar for laparoscopic use. The holding device is adapted to hold a prolongation of the body thatis adapted to be held by a surgical instrument More specifically, the holding device is adapted to hold a thmad or band inserted though the holding device. Where the body comprises an outer wall the holding device is atleast partly placed inside the outer wall of the body.

[0034] In one embodiment the apparatus according to the invention further comprise an adjustment device for adjusting at least the proximal part of the movement restriction device. Fbr this purpose, the movement restriction device can comprise a body, the size of which is hydraulically adjustable, and the adjustment device can comprise a hydraulic fluidreservoir that when implanted in the patient is connected to the body, and wherein the body's size is non-invasively rgulated by manually pressing the hydraulic fluid reservoir so as to adjust the amount of hydraulic fluid supplied to the body and therby the body's size. The apparatus can further comprise a hydraulic rgulation device comprising atleast one chamber that when implanted in the patient is invaginated in the patients stomach wall with the body and connected to the body, and wherin the amount of hydraulic fluid contained in the body is non-invasively rgulated by distributing fluid between the hydraulic reservoir and the at least one chamber. preferably, the at least one chamber is, when implanted in the patient filled with the hydraulic fluid using a pump in the rservoir so as to stretch the fundus wall to cmate satiety in the patient Further, the adjustment device further can comprise a mvese servo, wherein a small volume of fluid in the rservoir is compressed with a higher force and the chamber creates a movement of a larger total volume with less force per unit of volume. In one embo diment the bo dy forms a fist chamber, further comprising at least one additional body forming a second chamber smaller than the fist chamber, the fist and second chamber being in contact with each other, preferably in fluid communication with each other. The hydraulic rservoir is preferably adapted to be placed subcutaneously in the patient and the hydraulic rservoir is preferably adapted to be placed in the patient's abdomen The hydraulic rservoir may have a wall defining the volume therof, and the volume of the hydraulic reservoir is regulated by moving a wall portion of the wall of the hydraulic reservoir. The apparatus can comprise a motor for moving the wall portion The hydraulic rgulaion device can comprise a pump, and the hydraulic rservoir isrgulated by the pump pumping fluid between the hydraulic reservoir and said atleast one chamber. A mechanical device can operaively connected to the hydraulic megulaion device to be moved as the hydraulic mgulaion device is operated. In one embodiment atleastthe proximal part of the movement estricion device is mechanically rgulated. The apparatus can further comprise a motor for mechanically rgulating the movement restriction device.

[0035] In one embodiment the apparatus according further comprises a

second body that, when implanted in the paientwith the body, fills two volumes,

respecively, at two different parts of the paient's the stomach, therby affecting the

patient's rflux. The rflux disease tmatment device is adapted to be posDperatively

and non-invasively regulated, and adapted to be rgulated fim time to time such

that at a first time one of the filling bodies fills the volume at one of the parts of the

stomach and at a second time the other of the filling bodies fills the volume at the

other part of the stomach

[0036] In one embodiment, the apparatus according to the invention

comprises an adjustment device for adjusting the size and/ or shape of the

movement restriction device. The size of the movement restriction device can be

hydraulically adjustable, and the adjustment device can comprises a hydraulic fluid

reservoir that when implanted in the patient, is connected to the movement

restriction device, and the size of the movement restriction device can be non

invasively rgulated by moving hydraulic fluid between the hydraulic fluid reservoir

and the movement restriction device. The movement restriction device may be seen

as a body. The apparatus can further comprise a hydraulic rgulation device

comprising at least one chamber that, when implanted in the patient, is invaginated

in the patient's stomach wall with the body and connected to the body, and wherein the amount of hydraulic fluid contained in the body is non-invasively rgulated by distributing fluid between the hydraulic rservoir and the at least one chamber. The at least one chamber can, when implanted in the patient be filled with the hydraulic fluid using a pump in the rservoir so as to stitch the fundus wall to crate satiety in the patient Ruther, the adjustment device can comprise a reverse servo comprising there adjustable reservoirs with hydraulic fluid, wherein a small volume of fluid in a fistrservoir placed subcutaneously, being part of a first closed systemincluding a second reservoir, is compressed with a high force per aea unit for moving a small volume of hydraulic fluid, and wherein the second reservoir affects a larger volume of hydraulic fluid in a third reservoir, the third reservoir being part of a second closed system having larger volume than said first reservoir, thereby crating a movement of a larger total volume of hydraulic fluid with less force per aea unit

[0037] Ina special embodiment the movementrstoration device as outlined in the previous sections comprises two or mom movementrestriction device segments, preferably comprising moe than there segments, adapted to be assembled to an implantable assembled movement restriction device of a controlled size involving at least the proximal part of the movementrestriction device. The assembled movement restriction device is adapted to rst with at least a part of its outer surface against the patient s stomach fundus wall, in a position between the patient s diaphragm and the fundus wall, such that movement of the cardiac notch of the patient s stomach towards the patient s diaphragm isrstricted, when the movement estriction device is implanted in the patient to thereby prevent the cardia fim sliding through the patient s diaphragm opening into the patient s thorax, so as tomaintainthe supporting prssum against the patient s cardia sphincter muscle exerted fim the patient s abdomen The assembled movement restriction device preferably is adapted to disassemble into its segments if it leaves its implanted position of at least partially contacting the stomach fundus wall in a position between the diaphragm and the fundus wall. leferably, the assembled movement mstriction device is adapted to be invaginated in the stomach wall, and to disassemble into its segments if it leaves its implanted stomach position including penetrating the stomach wall to rtain a position inside the stomach 'The segments am preferably adapted to separately pass through the food passage way, therby reducing risk of causing obstrucion/ ileus in the patient's intestine. 'The movement restriction device segments can be adapted to pass through a trocar, for assembly and implantation of said movement estriction device into the abdominal cavity. The movementmrstriction device segments can have a flexible outer shape adapted to pass through a trocar. The movementmrstriction device segments can be adapted to have a shape allowing them to be assembled into said movement estriction device, when implanted. In one embodiment, the movement estriction device segments are hollow with a flexible outer surface. The movement estriction device segments can be adapted to be filled with atleast one of a fluid a foam, a gel or a fluid that hardens to a solid material. In one embodiment the movementrestriction device segments am solid. It is prfered that the movementrestriction device segments am adapted to temporary be holding their assembled position, preferably by the invaginated stomach wall, or alternatively by an adhesive.

[0038] Fbr its assembly, the movement restriction device is provided with at least one assembly element that sufficiently fits with at least one assembly element of another segment, so the segments by filing assembly elements can be assembled into the iiplantable movement estriction device. leferably, the segments for this purpose comprise a com part and a plurality of outer parts, and preferably, the at least one assembly element is selected among sufficiently filing flanges and slits. The com partis adapted to receive and assemble the outer elements into an implantable movement restriction device, and preferably the com parthas assembly slits adapted to receive cormsponding assembly flanges of the outer parts when assembling the movement restriction device. In one embodimentthe slits am distributed around the outer peripheral ama of the com part. 'he outer parts am then provided with flanges sufficiently matching the slits to assemble the device. In another embodiment, the at least one assembly element immobilizes each of the movement restriction device segments to a com part along a fist plane, and wherein movement ,and wherein the movement estriction device segments and the com part further comprises a second assembly element, which following the assembly of said segments and com part immobilize each segment and com part along a second plane in an angle to said fist plane. Fbr example, the first plane and the second plane can be substantially perpendicular. The second assembly element comprises mating elements, preferably with matching prtrusions and mecesses provided on the movement restriction device segments and the com part, while the at least one assembly element further comprises prtrusions and excesses. preferably, the at least one assembly element comprises an assembly slit in the com part and an assembly flange in a segment, and wherein a mating element comprises a prtrusion in said slit and a ecess in said flange; or alternatively, the at least one assembly element comprises an assembly flange in the com part and an assembly slit in a segment, and wherein the a mating element comprises a protrusion in said slit and a ecess in said flange.

[0039] In one particular embodiment, the apparatus preferably further comprises a guiding device, operable for assembling the movementrestriction device segments to an implantable movement estriction device. leferably, the guiding device is an operation wire operably connected to the segments.

[0040] The operation wire can be made of a material that's biodegradable in contact with the body fluid in the abdominal cavity so as to facilitate disassembly of the movement estriction device into its segments. In order to assist with assembly prcedue, each segment can be provided with at least one assembly element that sufficiently fits with at least one assembly element of another segment, so the segments by fitting assembly elements can be assembled into the implantable movement restriction device. In one embodiment the segments comprise a com part and a plurality of outer parts and in one embodiment wheein the assembly elements am selected among sufficiently fitting flanges and slits.

[0041] The co part preferably is adapted to receive and assemble the outer elements into an implantable movement restriction device. In one embodiment the com parthas assembly slits adapted toreceive cormsponding assembly flanges of the outer parts when assembling the movement restriction device. preferably the slits am distributed around the outer peripheral ama of the com parL The slits and flanges may be designed to have loose fit adapted keep the segments together as a movement restriction device atits implanted located, but assistwith disassemble the device if itinadvertently leaves such a position, for example to the stomach cavity. In such event the degradation of the guiding device will also assist with disassembling the movement restriction device into segments which am designed not cause any obstructions or in any other form damage the patient

[0042] In order to assemble the segments, the operation wir is connected to the com part and to the outer parts so the outer parts can be sequentially assembled to the com part so as to assemble the movementrstriction device. Fbr this purpose, the operation wire preferably is connected to the assembly flanges of the outer part and preferably, the com parties provided with atleast one operation channel for receiving the operation wir. preferably, each outer part is connected to two operation channels by the operation wie. In one embodiment a first operation channel has a fist orifice in an end surface of the com part and second orifice in a fist slit of the com part, so when displacing the operation wire received in said fist operation channel in a dimection fom said end surface, a first outer part is assembled to said com parL A second operation channel has two orifices in a second slit of the com part, so when displacing the operation wire connected to the fist operation channel in a directed fom the end surface, a second outer partis assembled to said com par leferably, the guiding wie prtrudes fim the fist channel orifice so it can be operated on with an instrument to displace the guiding wim and a first outer element so its assembly flange fits with its designated first assembly slit on the com element and in a prdetermined sequence in the same manner displacing the raining outer elements so as to assemble the implantable movement restriction device. The segments can comprise there or mom outer parts assembled to designated slits of the com part with the guiding wir through operation channels having orifices in each designated slit of said com parL In one embodiment the movement restriction device comprises one com part and four outer parts. However other ways of designing the segments within the present concept is feasible according to the skilled person The so assembled movementrestriction device can retain a generally spherical form, but as will be described later other shapes and additional function elements am made part of the present invention

[0043] Other features of the proximal part of the movementrestriction device will be described in the following part of description These features can be combined with any of the following features slated to the distal part of the movement restriction device.

[0044] In an advantageous embodiment of the apparatus now adapted to also trat obesity, the body is adjustable in size and invaginated in the patient s fundus stomach wall. As a msult the body stitches the patient s stomach fundus wall when the size therof is increased, therby crating satiety in a patient also suffering fim obesity. At least two implantable adjustable stitching devices may be provided to stitch different parts of the patient s stomach wall, to therby tmat obesity by efficiently affecting the patient s appetite. The two stitching devices am suitably rgulated fim outside of the patient s body, wherby a first of the stretching devices is gulated at a first time to stmich a first part of the patient s stomach wall and a second of the stitching devices is regulated at a second ime to stretch a second part of the paient's stomach wall.

[0045] The apparatus of the present invention in any form outlined in the pmvious sections can be further adapted to tmat obesity together withreflux disease as it is common that a patient suffers fom both complications. Fbr this purpo se the distal part of the movement restriction device is further adapted for obesity tmatment 'Ihe distal part will have the functionality of a volume filling device

[0046] In accordance with a first option, the distal part of the movement estriction device is adapted to be placed inside the stomach with the outer surface of the distal part ofsting against the inside of the stomach wall.

[0047] In accordance with a second option, the distal part of the movement restriction device is adapted to be placed outside the stomach with the outer surface of the volume filling device resting against the outside of the stomach wall.

[0048] referably, the distal part of the movementrestriction device is adapted to be completely invaginated by the stomach wall of the patient and to be placed inside or outside the stomach wall via a gastroscopic instrument I this end the distal part of the movement restriction device may comprise an attachment device adapted to co-operate with a gripping instrument Suitably, the distal part of the movement estriction device is adapted to be non-invasively adjustable postoperatively.

[0049] The apparatus may comprise a fixation device, suitably two or mom fixation devices, adapted to be involved in the fixation of the distal part of the movement restriction device to the stomach wall. The distal part of the movement restriction device may comprise a holding device adapted to be held by an instrument suitably two or mom holding devices, to simplify the implantation of the device.

[0050] At least a part of the distal part of the movement restriction device may be made of a material which is not destrucible by stomach acid. The distal part of the movement restriction device may be destructible by acids, for example hydrochloric acid.

[0051] In an embodiment the distal part of the movementrestriction device is inflatable to an expanded state and comprises an enclosure wall defining a chamber, the distal part of the movement restriction device is inflated with a gel or fluid supplied into the chamber. Atleast one tube may be connected to the distal part of the movement estricion device for supplying gel or fluid to the chamber. An injection port connectible with the tube may be provided. Altemaively, the distal part of the movement estriction device may be provided with an inlet port for a fluid or a gel connectible to a gastroscopic instrument, wheein the inlet port comprises a fluid connection adapted to interconnect the inflatable device and the gastroscopic instrument

[0052] The distal part of the movement estriction device may include a homogenous material, such as gel having a Shore value of less than 15. The device may also be a solid body.

[0053] At least one of the distal and proximal parts of the movement restriction device may at least to a part comprise a rigid, elastic or flexible outer surface. Where the outer surface is rigid, it is rigid enough to maintain non deformed when subject to foes heated by stomach movements. The distal part of the movement restriction device may comprise a flexible non-elastic material.

[0054] In accordance with a fist general design of the distal part of the movement restriction device, the device has a maximum circumfernce as seen in a plane perpendicular to an axis through the device. 'Ihe circumferences of the device as seen in other planes perpendicular to said axis am equal to the maximum cimrumfernce or decrease as seen along said axis in the diretion fim the maximum circumfernce. Fbr example, the device may be substantially egg shaped, spherically shaped, or substantially shaped like an egg with an indented middle section orlike a bentegg.

[0055] In accordance with a second general design of the device, the cimrumfernce of the device as seen in a plane perpendicular to an axis through the device increases and decreases atleast two times as the plane is displaced along said axis, or decreases and increases at least one time as the plane is displaced along said axis. Fbr example, the device may be substantially shaped like akidney.

[0056] The distal part of the movement estriction device has an elongated, rounded, bent and/ or curved shape.

[0057] The distal part of the movement estriction device has a cimumfernce of atleast30. 50, 80, 120, 150, 180 or220 mm.

[0058] The distal part of the movement estriction device has a volume in the range of0.0001 to 0.001 m3, or 0.00001 to 0.001 m3, or 0.00001 to 0.0002 m3. The volume of the volume filling device has a volume of less than 0.0002 m3.

[0059] The distalpartof the movement estriction device may comprise at least two intemconnectable portions adapted to be placed inside or outside the stomach as separate portions.

[0060] The distal part of the movement restriction device may comprise an elastic material, a bio-compatible material and/ or silicone. Suitably, atleast one of the distal and proximal parts of the movement restriction device is provided with at least one layer. Fbr example, a metal layer, a Paylene layer, a polytetrafluoroethylene layer or a polyurethane layer. The layer may comprise multiple layersin any order. Suitably, one of the layers may be made of made of metal, silicon or PIE The volume filling device may comprise an outer surface layer of silicone, polyurethane, Tflon@, or polytetrafluormethylene, metal, Parylene, PIE or a combination therof. The volume filling device may comprise an inner surface layer of silicone, polyurethane, Tflon@, or polytetrafluomiiethylene, metal, Paylene, PWIE or a combination therof. Other combinations of layers include an inner surface layer of polytetrafluorethylene and an outer layer of silicone, an inner surface layer of polytetrafluorethylene, an intermediate layer of silicone, and an outer layer of Paylene, an inner surface layer of polyurethane and an outer layer of silicone, and an inner surface layer of polyurethane, an intermediate layer of silicone, and an outer layer of Parylene.

[0061] The distal part of the movement restriction device may comprise a fluid adapted to be transformed into solid state or fixed form. Such a fluid maybe liquid polyurethane or isotonic. The fluid may comprises large molecules, such as iodine molecules, to prevent diffusion

[0062] The distal part of the movement restriction device may have a maximumcirurrmfernce of atleast50 milimetes, preferably atleast;80 millimeters. Suitably, the distal part of the movement estriction device is deformable to a maximum diameter, so as to be insertable into a laparoscopic tocar.

[0063] referably the distal part of the movementrestriction device is adapted to be kept in place by stomach-to-stomach suurs or staples to invaginate the device in the stomach wall. Advantageously, the distal part of the movement estriction device has varying cirumfernce to better be keptin place invaginated in the stomach wall of the patient The stomach-to-stomach sutures or staples may be provided with fixation portions exhibiting a structum adapted to be in contact with the stomach wall to promote growth in of human tissue to secum long term placement of the volume filling device attached to the stomach wall. he structure may comprise a net like structure.

[0064] In embodiment of the invention, the apparatus comprises a stretching device placed outside the stomach wall and adapted to strich a portion of the stomach wall, therby affecting the patients appetite. Where the volume filling device is inflatable, the apparatus may comprise a fluid connection interconnecting the stitching device and the volume filling device.

[0065] Ihe stitching device may be hydraulically rgulated. In his case, a subcutaneously irplantable hydraulic rservoir connected to the hydraulic rgulated stoetching device may be provided, whereby the hydraulicrgulated stitching device, when planted in the patient is adapted to be non-invasively rgulated using fluid frm the hydraulic reservoir. In one embodiment the hydraulic rgulated stoetching device is non-invasively rgulated by manually pressing the hydraulic reservoir. Rather, the movement restriction device suitably includes an inflatable body, and a pump and a chamber in fluid contact with the body a provided, wherein the pump rgulates the hydraulic rservoir by pumping fluid or air fim the body to the chamber.

[0066] Ihe apparatus may include an implantable simulation device that sends out stimulation pulses to the cardia muscle, especially the caria sphincter muscle to stimulate the cardia muscle and thereby further close the cardia to additionally prvent rflux disease. Ihe stimulation device is comprised of at least one conductor and atleast one electrode thatmrceives the simulation pulses and applies them to the cardia sphincter muscle to thereby simulate the cardia sphincter muscle. Ihe atleastone electrode may also be keptin place by the stomach oesophagal sutures or invagination in the stomach wall. The simulation pulses may be sent as a train of pulses, wherein the pulse train is repeated with a time beak in between, the beak extending the beak between each pulse in the pulse train.

lrferably, the simulaon device sends out a number of pulse trains in a row followed by a break longer than that between the pulse trains to let the muscle rest still keeping the cardia sphincter closed 'The stimulation device may include an electronic circuit and an energy source preferably adapted to incorporate the electronic circuit and energy source.

[0067] The stimulation device preferably comprises at least one sensor for sensing a physical parameter of the patient or a functional parameter of the movement restriction device and an intemal control unit for controlling the stimulation device.

[0068] Normally, the intemal control unit controls the stimulation device in response to information fim the sensor.

[0069] A sensor sensing a contraction wave of the esophagus, or any other parameter co-elated to food intake, sends the information to the intemal control unit and the internal control unitthen ceases the simulation in response to such information fim the sensor.

[0070] The stimulation device may, at any time, be controlled by the patient

[0071] This object is also obtained by providing an apparatus, the apparatus comprising an implantable movement restriction device having an elongated shape and having, when implanted in a patient a proximal and a distal part, wherein the proximal part is adapted to be at least partly invaginated by the patient's stomach fundus wall and having an outer surface that preferably includes a biocompatible material, wherein a substantial part of the outer surface of the proximal part of the movement restriction device is adapted to rst against the stomach wall without injuring the latter in a position between the patient's diaphragm and at least a portion of the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient s stomach towards the patients diaphragm isrstricted, when the movementrestriction device is invaginated, to thereby prvent the cardia fim sliding through the patient s diaphragm opening into the patient s thorax, so as to maintain the supporting pressum against the patient s cardia sphincter muscle exerted fim the patient s abdomen 'The distal part of the movement estriction device stabilizes and holds the proximal part and is adapted by substantially invaginated in the stomach wall. The fundus stomach wall is mom easily movable and therby stabilized by the distal part being invaginated in the stomach wall atleast partly below the fundus stomach wall. 'Ihe proximal part of the movement restriction device has a size of at least 125 mm3 and a circumference of atleast15 mm, further comprises an implantable stimulation device adapted to engage with the cardia sphincter of a patient and a control device for controlling the stimulation device to stimulate the cardia sphincter, wherein the stimulation of the cardia sphincter is made with energy pulses to increase sphincter tonus so that the cardia closes and said control device is operable by the patient in that it can be set out of operation, wherein the control device is further operable by the patient to set the stimulation device into operation, in which operational state the stimulation device continuously alternates at a time when the patient does not swallow between an operation mode, in which the cardia sphincter is stimulated with said energy pulses, and a rest mode, in which the cardia sphincter is not stimulated.

Movement restriction device

[0072] The movement estriction device of the apparatus will be described. It is to be understood that in the present context all features, functionalities or adaptations described with the movement restriction device in this section am mlated to its proximal part, even if this is not explicitly mentioned. However, all features, embodiments, or part of embodiments as well as any method described in this application may, where applicable, be used for both the proximal or distal part of the device.

[0073] The apparatus comprises an implantable movement estricion device having an outer surface thatincludes a biocompaible material, wherein the movement restriction device is adapted to rstwith atleasta partof its outer surface againstthe patienf s stomach fundus wall, in a position between the patient s diaphragm and the fundus wall, such that movement of the cardiac notch of the patient s stomach towards the paiens diaphragmis rstricted, anapparatusfor mating GastroFsophageal Reflux Disease is obtained. The movement estriction device has a size of atleast125 mm3 and a circumfernce of atleast15 mm and restricts movement of the cardiac notch of the patient s stomach towards the patienf s diaphragm therby prventing the cardia fim sliding through the patient s diaphragm opening into the patient s thorax, maintaining the supporting prssume against the patient s cardia sphincter muscle exerted fim the patient s abdomen Exation device am adapted to secum the movementrestriction device in said position

[0074] By adapting the outer surface of the implanted movementrestriction device to rst against the wall of the fundus, there is a minimal risk of complications, such as migration of damage to tissue, because the fundus is less fragile than the esophagus.

[0075] In a first embodiment of the invention, the fixation device comprises sutures or staples that attach together portions of the fundus stomach wall that enclose the movement restriction device to secum the movement restriction device in said position. I e., the movementrstriction device is atleast partly placed in an invaginated space. hus, by affixing the implantable movementrestriction device indimcfly in this manner, no suturing between the movementrestriction device and tissue is requimed, which, in turn, further reduces the risk for complications.

Keeping the movement restriction device in place in this manner has msulted in an elastic suspension with improved long term pmperties.

[0076] The fixation device, such as sutums or staples, may attach together portions of the fundus stomach wall so at to substantially or completely invaginate the movement restriction device fmm either inside or outside of the patient s stomach wall. Whem the movementmstriction device is placed on the outside of the patients stomach wall, the movement estriction device is invaginated by the fundus stomach wall such that the stomach cavity is substantially reduced, by a volume substantially exceeding the volume of the movement restriction device.

[0077] In a another embodiment of the invention, the fixation device comprises an implantable fist fixation device that attach the movement restriction device in said position to the fundus wall, a second fixation device that secums, indimcly or dimcly, the movement estriction device to the esophagus close to the patient s angle ofHis, and a third fixation device that secums, indimcly or dimcly, the movement restriction device to the patient s diaphragm muscle or associated muscles. Any of the fist second and third fixation devices may be comprised of a plurality of sutums or staples. The fist fixation device may comprise a tissue gmwth promoting structum for long term attachment of the movement estriction device to the stomach wall. The tissue gmwth promoting structum may be sutumd to the stomach wall with a relatively large contact surface towards the stomach. 'Ihe relatively large surface of the structum, such as a net will allow for in-gowth of human tissue for holding the movement restriction device in place over the long term. The tissue gmwth promoting structum may comprise sutums or staples that attach the net like structum to the fundus stomach wall.

[0078] In addition to invaginating the movement restriction device in accordance with the first embodiment of the invention, the second fixation device can be used to secum, indimcly or dimcly, the movement estriction device to the esophagus close to the patient s angle of His, and the third fixation device may be used to secue, indimectly or diretly, the movement restriction device to the patient s diaphragm muscle or other muscle tissue.

[0079] Atleasta partof the movementrstriction device may be made of a material which is destructible or not destructible by stomach acid.

[0080] The movementrestriction device may be inflatable and adapted to be inflated with a gel or fluid. A fluid or gel receiving member for receiving fluid to inflate the movementrestriction device may be provided.

[0081] The movement restriction device may include a homogenous material and may be a solid body.

[0082] The movement restriction device may include an enclosure wall defining a chamber.

[0083] The movement restriction device may have a rigid, elastic or flexible outer wall. Where the outer wall is rigid, itis rigid enough to maintain non deformed when subject to foes heated by stomach movements. Where the movement restriction device is invaginated, in accordance with the fist embodiment described above, the movementrstriction device preferably comprises a body adapted to be atleast partly invaginated by the patient s stomach fundus wall and having an outer surface thatincludes a biocompatible material. A substantial part of the outer surface of the body is adapted to rst againstthe stomach wall in said position between the patient s diaphragm and the portion of the lower part of the invaginated stomach fundus wall. Suitably, the body is made of a material softer than 25 or 15 shume.

[0084] In accordance with a fist general design of the body, the body has a maximum circumference as seen in a plane perpendicular to an axis through the body. The circumfernces of the body as seen in other planes perpendicular to said axis am equal to the maximum circumfernce or decrease as seen along said axis in the diretion fim the maximum circumfernce. Fbr example, the body may be substantially egg shaped, spherically shaped, or substantially shaped like an egg with an indented middle section or like a bent egg.

[0085] In accordance with a second general design of the body, the cimrumfernce of the body as seen in a plane perpendicular to an axis through the body increases and decreases atleasttwo times as the plane is displaced along said axis, or decreases and increases atleastone time as the plane is displaced along said axis. Fbr example, the body may be substantially shaped like akidney.

[0086] referably, the body is dimensioned with a size larger than the intestinal outlet fim the stomach The body may have a smallest outer diameter of or 40mm or larger and may have a smallest outer cirumference of 150, 110, , 70, 50 or 30 mm.

[0087] Suitably, the body has rounded contours withouttoo sharp edges that would be damaging to the patient's stomach wall, and has a generally smooth outer surface for resting against the fundus wall.

[0088] The body is implantable either inside or outside of the patient's stomach and is adapted to be attached to the patient's stomach wall by surgery. The body may be changeable to assume a slender formhaving a smaller diameter than that of a tocar for laparoscopic use, whermby the body when changed to said slender form can be pushed or pulled though the trocar. The body may include a flexible outer wall defining a chamber filled with a fluid, such as a gel, allowing the body to pass though such a tocar. Altemaively, the body may include an elastic compressible material, allowing the body to pass though a trocar.

[0089] The body may be hollow and include atleast two separate pieces adapted to be inserted into the hollow body, and further adapted to be put together to one unitay piece inside the body, therby allowing the body to pass through a trocar for laparoscopic use. Alternaively, the body may include an outer wall and a hollow compressed inner part, for being filled with a fluid or gel after insertion into the paienfs body.

[0090] The body may include a chamber with an injection port, wherein the chamber of the body is filled with a fluid though the injection port.

[0091] The body may include atleast one holding device adapted to be used for pushing or pulling the body through a trocar for laparoscopic use. The holding device is adapted to hold a prolongaion of the body thatis adapted to be held by a surgical instrument More specifically, the holding device is adapted to hold a thmad or band inserted through the holding device. Where the body comprises an outer wall the holding device is atleast partly placed inside the outer wall of the body.

[0092] In an advantageous embodiment the body is adjustable in size and invaginated in the paienes fundus stomach wall. As a msult the body strtches the patient s stomach fundus wall when the size thereof is increased, thereby crating satiety in a patient also suffering fim obesity. At least two implantable adjustable stoetching devices may be provided to stitch different parts of the patient s stomach wall, to therby trat obesity by efficiency affecting the patient s appetite. The two stretching devices am suitably rgulated fim outside of the patient s body, whereby a fist of the stitching devices is rgulated at a fist time to stmich a first part of the patient s stomach wall and a second of the stitching devices is rgulated at a second time to stmich a second part of the patient s stomach wall.

[0093] The stitching device may be hydraulically rgulated. In this case, a subcutaneously implantable hydraulic rservoir connected to the hydraulic rgulated stoetching device may be provided, whereby the hydraulicrgulated stitching device is non-invasively rgulated by manually pressing the hydraulic rservoir. Rather, the movement estriction device suitably includes an inflatable body, and a pump and a chamber in fluid contact with the body a provided, wherin the pump rgulates the hydraulic rservoir by pumping fluid or air fim the body to the chamber.

[0094] The apparatus may include an implantable stimulation device that sends out stimulation pulses to the cardia muscle to simulate the cardia muscle and therby further close the cardia to additionally prventrflux disease. The stimulation device is comprised of atleast one conductor and atleast one electrde that receives the stimulation pulses and applies them to the cardia muscle to therby stimulate the cardia muscle. The at least one electrode may also be kept in place by the stomach-oesophagal sutures or invagination in the stomach wall. The simulation pulses may be sent as a train of pulses, wherein the pulse train is mpeated with a time break in between, the break extending the break between each pulse in the pulse train. The stimulation device may include an electronic circuit and an energy source preferably adapted to incorporate the electronic circuit and energy source.

[0095] The stimulation device preferably comprises at least one sensor for sensing a physical parameter of the patient or a functional parameter of the movement restriction device and an intemal control unit for controlling the stimulation device.

[0096] Normally, the intemal control unit controls the stimulation device in response to information fom the sensor.

[0097] A sensor sensing a contraction wave of the esophagus, or any other parameter coelated to food intake, sends the information to the intemal control unit and the intemal control unit then ceases the stimulation in response to such information fom the sensor.

[0098] The stimulation device may, at any time, be controlled by the patient

Stimulation device

[0099] The stimulation device of the apparatus will now be described.

[00100] The control device is operable by the patient to control the stimulation device to continuously altemate between an operation mode, in which the cardia sphincter is stimulated with energy pulses, and a restmode, in which the cardia sphincter is not stimulated. (The term "patient" includes an animal or a human being.)'The continuous altemation between the operation and rest modes gives the advantage that the cardia sphincter is able to "recover" during the rest modes and as arsultbe mom sensitive during the operation modes. Another advantage is that the energy consumption of the new apparatus will be considerably lower as compared with the above-discussed prior continuous stimulation system.In addition, since the contml device is operable by the patient he or she may choose when the apparatus should be in operation For example, for some patients itmay be sufficientto keep the apparatus temporarily "on when the patient feels rflux troubles, such as at night when the patient is lying, others may need to have the apparatus all the time "on", except when the patient eats.

[00101] In accordance with a prfered embodiment of the invention, the apparatus comprises a source of energy, wherein the control device controls the source of energy to release energy for use in connection with the power of the stimulation device, when the simulation device is implanted. As a msult the apparatus of the invention provides a simple and effective control of the energy supplied to implanted components of the apparatus, which ensues an extended and reliable functionality of the apparatus, possibly for the rest of the parents life and at least many yea.

[00102] In the preferred embodiment the control device maybe controllable from outside the paient's body to control the simulation device to vary the intensity of the stimulation of the cardia sphincter over time. More specifically, the control device may be adapted to control the stimulation device to change the intensity of the stimulation of the cardia sphincter so that the cardia sphincter tonus is changed.

[00103] referably, the source of energy comprises an electric source of energy and the control device is adapted to control the electric source of energy to deliver electric pulses to the simulation device. An implantable switch for switching the delivery of electric pulses from the electric source of energy may be provided. 'The switch may be manually operable by the patient or, alternatively, the control device may comprise a wireless rmote control operable by the patient to control the switch

[00104] Where the simulation device stimulates the cardia sphincter with

electric pulses there may be a problem of providing a voltage intensity strong enough to achieve the desired electric simulation of the cardia sphincter. his is so because the intensity of the electric stimulation might fade over time, due to increasing electric rsistance caused by the formation of fibrosis where electric conductors engage the cardia sphincter. his problem is solved by a main embodimentof the present invention, in which the simulation device comprises electric conductors for engaging the cardia sphincter, the electric source of energy is adapted to provide a current through the electric conductors, and the control device is adapted to control the electric source of energy to release electric energy such that the intensity of the current through the electric conductors amounts to a predetermined value. As a msult decreasing curentintensity caused by the formation of fibrosis where the conductors engage the cardia sphincter can be compensated for. hus, if the current through the conductors decreases the control device automatically controls the electric source of energy to release mom electric energy to estom the desired curentintensity.

[00105] Advantageously, the control device is adapted to control the electric source of energy to release energy in the form of an alternating current The inventor has found that unlike an alternating current a dimct current could cause electrolysis in the cardia sphincter. Such electrolysis could injum the cardia sphincter.

[00106] All of the above embodiments may be combined with atleast one implantable sensor for sensing at least one physical parameter of the patient wherein the control device may control the stimulation device in response to signals fim the sensor. In particular, the sensor may sense as the physical parameter the contraction wave in the esophagus caused by the patient swallowing food. In this case the stimulation device is adapted to cease the stimulation of the cardia sphincter in response to the sensor sensing the contraction wave in the patient's esophagus.

[00107] As an altermative, the sensor may comprise a prssum sensor for dimnecty or indirectly sensing the prssum in the esophagus. The expression "indircty sensing the prssum in the esophagus" should be understood to encompass the cases where the sensor senses the prssum against the stimulation device or human tissue of the patient

[00108] The contml device may comprise an intemal control unit preferably including a micrprocessor, to be implanted in the patient for controlling the stimulation device. The internal contml unit may suitably directly control the stimulation device in response to signals fim the sensor. In response to signals fim the sensor, for example prssue, the patient s position, the contraction wave in the patient s esophagus or any other important physical parameter, the intemal control unitmay send information theron to outside the patient s body. 'The control unit may also automatically control the stimulation device in response to signals fOm the sensor. Fbr example, the control unit may control the simulation device to efficiently stimulate the caria sphincter, such that the cardia for certain is completely closed in response to the sensor sensing that the patient is lying.

[00109] The contml device may also, or alternatively, comprise an extemal control unit outside the patient s body, wherein the intemal contml unit is programmable by the extemal controlunit for example for controlling the stimulation device over time. Altematively, the intemal control unit may control the stimulation device over time in accordance with an activity schedule program, which may be adapted to the patient s needs.

[00110] The extemal control unit may also, suitably directly, control the stimulation device in response to signals fom the sensor. 'Ihe extemal control unit may store information on the physical parameter sensed by the sensor and may be manually operated to contml the simulation device based on the stord information. In addition, there may be at least one implantable sender for sending information on the physical parameter sensed by the sensor.

[00111] A grat advantage is that the patientis enabled to keep the cardia completely closed by means of the stimulation device by using the control device whenever he likes during the day. Ihis advantage should not be underestimated, because in case the patientwould need to vomititwould be very difficultfor him to do so if he wem unable to immediately stop the simulation of the cardia.

[00112] Conveniently, the external control unitmay load the intemal control unit with data in accordance with a loading mode only authorised for a doctor. Fbr specialised conrls of the stimulation device, such as electric power, electric pulse frequency etc, the extemal contml unit may control the inemal control unitin accordance with a doctor mode only authorised for the doctor. Fbr simple control of the stimulation device, such as "on" and "off', the extemal control unit may conrl the eiemal conrl unit in accordance with a patient mode permitted for the patient hus, by using the extemal control unit in accordance with different modes it is possible to have certain funcions of the simulation device conrolled by the patient and other mom advanced functions controlled by the doctor, which enables a flexible po st-operation treatment of the patient

[00113] The conrl device may be adapted to control the source of energy to release energy, for instance to intermittently release energy in the form of a train of energy pulses, for direct use in connection with the power of the simulation device. In accordance with a suitable embodiment the control device control the source of energy to release electric energy, and the apparatus further comprises an implantable capacitor for producing the train of energy pulses frm the released energy. In this case the term "dirce' is used to mean, on one hand, that the released energy is used while itis being released by the control device, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabilizer before being used in connection with the power of the simulation device.

[00114] Rulher below is described further embodiments slated to energy supply and control. All these embodiments may be used for all the different applicable embodiments in this application not only for the simulation device.

[00115] In accordance with an embo diment of the invention, the apparatus comprises implantable electrical components including at least one, or only one single voltage level guard and a capacitor or accumulator, wherein the charge and discharge of the capacitor or accumulator is contrlled by use of the voltage level guard.

[00116] In one embodiment the soure of energy is extemal to the paient's body and the control device control the source of energy to release wireless energy. An energy storage device, preferably an electric accumulator, may be implanted in the paientfor storing the wireless energy released fim the extemal source of energy. Ihe electric accumulator may comprise atleast one capacitor or atleastone rechargeable battery, or a combination of atleastone capacitor and at least one rechargeable battery. Altemaively, a battery may be implanted in the patient for supplying electric energy to implanted electric energy consuming components of the apparatus, in addition to the supply of wireless energy. Where the control device comprises an implantable control unitthe elecronic circuitthemeof and the simulation device may be dimctly powered with transformed wireless energy, or energy fim either the implanted energy storage device or battery.

[00117] In one embo diment the wieless energy is dircty used for the power of the simulation device, i.e. the stimulation device is powered as the wireless energy is released fim the extemal source of energy by the control device. In this case the term "dirmcty" is used to mean, on one hand, that the stimulation device is promply powered by using the released energy whiteout first storing the latter, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabilizer before being used for the power of the simulation device. Both the wireless energy may be used to cmate dimectkinetic energy the wireless field affecting an the apparatus dimcty or by using an energy transforming device, transforming the wireless energy to electric energy which may be used to power any energy consuming parts of the apparatus dicty during wireless energy transmission or indimect after charging an accumulator. As a result, a very simple control of the stimulation device is achieved and there am only a few implanted components of the apparatus. Fbr example, there is no implanted source of energy, such as a battery, nor any implanted complicated signal control system. Ihis gives the advantage that the apparatus will be extremely liable.

[00118] In one embodiment the source of energy comprises an implantable internal source of energy. hus, when the internal source of energy is implanted in a patient the control device control it fim outside the patient's body to release energy. his solution is advantageous for sophisticated embodiments of the apparatus thathave arelatively high consumption of energy that cannotbe satisfied by direct supply of wireless energy. The intemal source of energy prferably comprises an electric source of energy, such as an accumulatoror a battery. Alternatively, the conrl device may be adapted torelease wireless energy fim the intemal source of energy and to contml the simulation device to stimulate the patient's cardia sphincter with the released wireless energy. The wireless energy may comprise radiant energy or sound energy, such as ultrasound energy.

[00119] In one embodiment of the invention, the apparatus comprises a switch implanted in the patientfor dirctly or indimecty switching the power of the stimulation device and an intemal electric source of energy, such as a battery, implanted in the patient for supplying electric energy for the power of the simulation device, wheein the switch dimctly or indimecty affects the supply of electric energy fim the intemal electric source of energy. Ihis solution is advantageous for embodiments of the apparatus that have arelatively high consumption of energy that cannot be met by dimct supply of wireless energy.

[00120] In one embodiment of the invention, the switch switches between an "off' mode, in which the intemal electric source of energy is not in use, and an "on"

mode, in which the intemal electric source of energy supplies electric energy for the power of the simulation device. In this case, the switch is conveniently operated by the wireless energy released fim the extemal source of energy to switch between the "on" and "off' modes.Ihe control device, preferably comprising a wireless remote control, may control the extemal source of energy to release the wireless energy. The advantage of this embodimentis that-the lifetime of the implanted electric soure of energy, such as a battery, can be significantly prolonged, since the implanted source of energy does not supply energy when the switch is in its off mode.

[00121] h one embodiment, the control device comprises a wireless rmote control for controlling the internal electric source of energy. In this case, the switch is operable by the wireless energy fom the extemal source of energy to switch between an "off' mode, in which the intemal electric source of energy and emote control am notin use, and a "standby" mode, in which the emote contml is permitted to control the intemal electric source of energy to supply electric energy for the power of the simulation device.

[00122] h one embodiment the apparatus further comprises an energy transforming device to be implanted in the patient for transforming the wireless energy into storable energy, and an implantable energy storage device for storing the storable energy, wherein the switch is operable by energy fom the implanted energy storage device to switch between an "off' mode, in which the intemal electric source of energy is not in use, and an "on' mode, in which the intemal electric source of energy supplies electric energy for the power of the simulation device. In this case, the control device suitably comprises a wireless remote control for controlling the energy storage device to operate the switch

[00123] An extemal data communicator may be provided outside the patients body and an intemal data communicator to be implanted in the patient may be provided for communicating with the extemal data communicator. The intemal data communicator may feed data slated to the patient,or slated to the stimulation device, back to the external data communicator. Alternatively or in combination, the extemal data communicator may feed data to the intemal data communicator. The intemal data communicator may suitably feed data slated to at least one physical signal of the patient

[00124] Suitably, an implantable stabilizer, such as a capacitor, a rechargeable accumulatoror the like, may be provided for stabilizing the electric energy released by the control device. In addition, the control device may control the source of energy to release energy for a determined time period or in a determined number of energy pulses.

[00125] All of the above embodiments ae prferably mmote controlled. 'hus, the control device advantageously comprises a wireless rmote control transmitting at least one wireless contml signal for conrolling the stimulation device. With such a mmote contml itwillbe possible to adaptthe function of the apparatus to the patient's need in a daily basis, which is beneficial withrespect to the tmatment of the patient

[00126] Ihe wireless rmote control may be capable of obtaining information on the condition of the simulation device and of controling the stimulation device in response to the information. Also, the emote control may be capable of sending information slated to the simulation device fim inside the patient's body to the outside thereof.

[00127] Ina particular embodiment of the invention, the wireless rmote control comprises at least one extemal signal transmitter or transceiver and at least one intemal signal receiver or transceiver implantable in the patient In another particular embodiment of the invention, the wireless rmote control comprises at least one extemal signal receiver or transceiver and at least one intemal signal transmitter or transceiver implantable in the patient

[00128] The remote control may transmit a carrier signal for carrying the control signal, wherein the carrier signal is fiquency, amplitude or fmquency and amplitude modulated and is digital, analogue or digital and analogue. Also the control signal used with the carrier signal may be fquency, amplitude or fmquency and amplitude modulated.

[00129] The control signal may comprise a wave signal, for example, a sound wave signal, such as an ultrasound wave signal, an elecromagnetic wave signal, such as an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, or a gamma radiation signal. Where applicable, two or mom of the above signals may be combined.

[00130] The control signal may be digital or analogue, and may comprise an electric or magnetic field. Suitably, the wireless rmote control may transmit an electromagnetic carrier wave signal for canying the digital or analogue control signal. Fbr example, use of an analogue carrier wave signal canying a digital control signal would give safe communication. The control signal may be transmitted in pulses by the wireless rmote contrl.

[00131] The contml device may be activated in a manual or non-manual manner to control the source of energy to release energy.

[00132] In the above-presented embodiments of the invention the released energy may comprise electric energy and an implantable capacitor having a capacity less than 0,1 Fmay be provided for producing the above-mentioned train of energy pulses.

[00133] Generally, the wireless energy comprises a signal.

[00134] The apparatus may further comprise an implantable energy transforming device for transforming wireless energy, for example in the form of sound waves, directly or indiectly into electric energy, for the power of the stimulation device. More specifically, the energy transforming device may comprise a capacitor adapted to produce electric pulses fmmthe transformed electric energy.

[00135] Generally, the stimulation device advantageously is embedded in a soft or gel-like material, such as a silicone material having hardness less than 20 Shore.

[00136] The stimulation device may comprise a band for application around the cardia, wherein the band has electric conductors for contacting the cardia sphincter. The electric conductors may comprise hooks to secue the conductors on the cardia.

[00137] The presentinvention also provides a system for rating heartburn and rflux disease, comprising an implantable simulation device adapted to stimulate the cardia sphincter of a patient to increase the sphincter tnus, and a control device that controls the stimulation device to continuously altemate between an operation mode, in which the cardia sphincter is stimulated with energy pulses, and a rest mode, in which the cardia sphincter is not stimulated. The energy pulses may comprise electric pulses. The simulation device may comprise electric conductors for engaging the cardia sphincter, and an electric source of energy may be adapted to provide a currentthough the electric conductors to form the electric pulses. Advantageously, the control device may control the electric source of energy to release the electric energy such that the current through the electric conductors amounts to a prdetermined value.

[00138] All the above described various components may be combined in the different embodiments where applicable. Also the various functions described in connection with the above embodiments of the invention may be used in different applications, where applicable.

[00139] All the various ways of transferring energy and controlling the energy presented in the present specification may be practiced by using all of the various components and solutions described.

[00140] The present invention also provides methods for treating heartburn and rflux disease.

[00141] Accordingly, in accordance with a fist altermaive method, there is provided a method of tmating heartburn and rflux disease, comprising the steps of:

[00142] implanting an stimulation device in a patient so that the stimulation device engages the cardia, and

[00143] controlling the stimulation device to continuously altemate between an operation mode, in which the cardia sphincter is simulated with energy pulses to increase the sphinctertonus, so thatthe cardia completely closes, and a restmode, in which the cardia sphincter is not stimulated.

[00144] The fistaltemative method may also be performed laparoscopically. hus, there maybe provided a laparoscopic method of tmating heartburn and rflux disease, comprising the steps of:

[00145] laparosopically implanting an stimulation device in a patient so that the stimulation device engages the cardia, and

[00146] controlling the stimulation device to continuously altemate between an operation mode, in which the cardia sphincter is simulated with energy pulses to increase the sphincter tonus, so that the cardia completely closes, and a restmo de, in which the cardia sphincter is not stimulated.

[00147] In accordance with a second alternative method, there is provided a method of treating a patient having heartburn andrflux disease, comprising:

[00148] (a) Surgically implanting in the patient an electric stimulation device engaging the cardia.

[00149] (b)rviding a source of energy extemal to the patient's body.

[00150] (c) Controlling the external source of energy fim outside the patient's body to release wireless energy. And

[00151] (d) using the released wireless energy in connection with the powering of the simulation device.

[00152] 'The second alternative method may further comprise implanting an energy transforming device, controlling the extemal source of energy to release wireless energy, and transforming the wireless energy by the energy transforming device into energy different fim the wireless energy for use in connection with the power of the simulation device. This method may further comprise implanting a stabilizer in the patientfor stabilizing the energy transformed by the energy transforming device.

[00153] There is also provided a method of tmating heartburn and rflux disease, comprising the steps of: implanting a stimulation device in a patient to engage the cardia sphincter, providing a control device for controlling the stimulation device to stimulate the cardia sphincter to increase the sphincter tonus, so thatthe cardia completely closes, and pemitting the patientto operate the control device to vary the intensity of

[00154] In one embodimentther is provided an apparatus where the stimulation of the cardia sphincter is made with energy pulses to increase the sphincter tonus so that the cardia completely closes and said control device is operable by the patient in that it can beset out of operation, wherin the control device is further operable by the patient to set the stimulation device into operation, in which operational state the stimulation device continuously alternates between an operation mode, in which the cardia sphincter is stimulated with said energy pulses, and a rest mode, in which the cardia sphincter is not stimulated, wherin the apparatus further comprises at least one implantable sensor for sensing at least one physical parameter of the patient wherein the control device is adapted to control the stimulation device to cease the continuous altemation between the operation mode and the rest mode and to put the stimulation device in the rest mode in response to the sensor sensing the physical parameter of the patient

[00155] In one embodiment there is provided an apparatus where the stimulation of the cardia sphincter is made with energy pulses to increase the sphincter tonus so that the cardia completely closes and said control device is operable by the patient in that it can be set out of operation, wherein the control device is further operable by the patient to set the stimulation device into operation, in which operational state the stimulation device continuously alternates between an operation mode, in which the cardia sphincter is stimulated with said energy pulses, and a rest mode, in which the cardia sphincter is not stimulated, wherin the apparatus further comprises at least one implantable sensor for sensing as a physical parameter of the patient at least the contraction wave in the esophagus caused by the patient swallowing food, wherein the control device is adapted to control the stimulation device to cease the continuous altemation between the operation mode and the rest mode and to put the stimulation device in the rest mode in response to the sensor sensing the contraction wave in the patient's esophagus.

Surface structum

[00156] The surface structure of the various implants of the invention will now be described.

[00157] The presentinvention concerns an implant, adapted to post operatively be adjustable and comprising atleast one expandable section, wherein the implants adapted to be adjustable between a fist collapsed state and a second expanded state. In the fist collapsed state the expandable section is collapsed, and in the second expanded state, the expandable section is expanded. The outer surface of said expandable section does atleast partly comprise a surface structum having elevated amas alternating with lowered amas. The expandable section is adapted to have, in atleast one of said fist collapsed and second expanded states a fist distance between adjacent elevated amas sufficiently extended to prvent grwth of fibrotic tissue fm dimctly interconnecting adjacent elevated areas to an extent that compromises the adjustability between a fist collapsed and a second expanded state of said implant The expandable section further comprising connecting amas between adjacent elevated and lowered amas, further adapted to have, in atleast one of said fist collapsed and second expanded states, a second distance between adjacent connecting amas sufficiently extended to prevent growth of fibrotic tissue fm diecly interconnecting adjacent connecting amas to an extent that compromises the adjustability between a fist collapsed and a second expanded state of said implant

[00158] According to one embodiment the expandable section is hollow or comprises a hollow body.

[00159] According to another embodiment the implantis substantially completely hollow or comprises a hollow body extending along substantially the complete length and/ or complete volume of said implant

[00160] Fbrotic tissue can often have an extension or thickness of about 0,5 mm to about 1,5 mm and hence the distances between levant surfaces of the elements of the surface structum am suitably grater than about 3 mm, hence greater than about 2 x 1,5mm. But depending on the circumstances also distances greater than about1.0 mmto about3 mmmay be sufficient In cases where the fibrotic issue can be expected to have an extension or thickness grater than about 1.5 mm the distances between levant surfaces of the elements of the surface structum am adapted in a suitable manner.

[00161] The surface structum may comprise elevated and lowered amas and it may be suitable that also a distance between the different planes of the elevated and lowered aas is bigger than a certain threshold to facilitate the collapsible and/ or expandable functionality of the implant If said distance is too small, the collapsible and/ or expandable functionality of the implant may be limited. A suitable interval for said distance is around 0,5 to 10 mm, mor suitable around2-8mandmostsuiableaund 3-7 mmThe surface structum may comprise different geometrical elements or shapes and any combination of such elements or shapes as long as the above mentioned conditions for the distances can be met The surface structum may e.g. comprise ridges and grooves of different shapes. 'Ihe ridges and grooves may each have a cross-section that's e.g. wedge shaped, polygonal, squam-foried, pyramidal-shaped, tncated pyramidal-shaped or. Rather may the ridges and grooves have crss-secions of different shapes. The surface structum may as well in general comprise a bellows-shaped structum or a surface structum where geometrical objects of the same or differentkind(s) am placed on a surface. The geometrical objects may be practicallyrandomly placed on the surface or according to some scheme.

[00162] One type of implants where this type of surface strnctum may be suitable is implants where the implant should have the ability to change shape and/ or size substantially. Hence, this is a case where the presence of fibroic tissue substantially could hinder or impede the function of the implant But-the surface structum may be used by any implant where the characteristics of the surface structum would be advantageous for the implant

Combination with obesity treatment

[00163] The various embodiments can be combined with various methods for tmating obesity. In particular two embodiments, one comprising a stitching device and one comprising a volume filling device, will be described below.

Stoetching device fortmrating obesity

[00164] Rease note that all embodiment or part of embodiments or methods may be used where applicable for all the different embodiments in this application

[00165] In addition the various embodiments the apparatus for tmating rflux can be combined with a device for the tmatment of obesity that that is based on the ralization that by creating a stitching effect of the stomach wall a feeling of satiety is cmated. By means of providing an apparatus with a stitching device something part of the stomach wall, a simpler, safer and long term working apparatus is provided.

[00166] The expression "powered" should be understood as energized with everything without manual fore, preferably electric energy. In other words, the adjustment device is operated in a non-manual manner. The expression "non manual manner' should be understood to mean that the adjustment device is not operated by manually touching subcutaneously implanted components of the apparatus or not manipulated by touching the skin of the patient hus, as opposed to prior practice when tmating anal incontinence, the adjustment device of the invention is not operated by manual forces, such as by manually compressing a fluid containing balloon implanted in the scrotum or in the region of labia major. Of course, manual manipulation of an implanted reservoir or other mechanical or hydraulic solutions may also be used as well as manual manipulation of a subcutaneous start button or the like for activating the powered operation device everything is permitted within the scope of the present invention

[00167] Altematively, or preferably in combination with a powered operation device, the servo means may be used, which enables for example a motor to run with high speed and low force and with for example a gear box to

decrease the speed and increase the force or toqnue. The servo means may comprise hydraulic means, electric control means, magnetic means, or mechanical means, which may be activated by manual manipulating means and/ or rmote control. Using a servo system will save the use of force when adjusting the adjustment device, which may be of importance in many applications.

[00168] 'ie term "servo means" encompasses the normal definition of a servo mechanism, i.e. an automatic device that controls large amounts of power by means of very small amounts of power, but may alternatively or additionally encompass the definition of a mechanism that tnsfers a weak force acting on a moving element having a long srke into a srng force acting on another moving element having a short strke. The servo means may comprise a motor, prferably an electric motor, which may be reversible.

[00169] Altematively, or prferably in combination with a manual manipulation, a reversed servo means may be used, which enables for example a the patients hand to use a higher force to with for example manipulate a hydraulic reservoir to move a small amount of fluid with strong force to conrl a larger movement of fluid. The reversed servo means may comprise hydraulic means, electric conrl means, magnetic means, or mechanical means, which may be activated by manual manipulating means and/ or rmote controlled. Using a reversed servo system will save the use of srke when adjusting the adjustment device, which may be of importance in many applications.

[00170] The term "rversed servo means" encompasses the definition of an device that is controlled with a higher force and a small stmke i.e. for example movement of a small amount of fluid with a high force contmls a larger amount of fluid moving by means of very smallerforce, but may altemaively or additionally encompass the definition of a mechanism that transfers a strong force acting on a moving element having a short stroke into a small force acting on another moving element having a long sroke. The reversed servo means is preferably used when manual contml of the device through intact skin is possible.

[00171] In general, two points on the stomach wall should be moved in elation to each other and away fim each other to cause dissension of a small part of the stomach wall, therby causing satiety. Ihis could be done in many different ways. One way is to expand an invaginated device invaginated in the stomach wall. Another way is to move two fixation points on the stomach wall. Of course first and second positions may be sutued or fixated to the stomach wall in many possible ways and the invention cove all possibilities to distend the stomach wall by moving two portions of the stomach wall away fim each other and therby a fist fixation of the device being moved in elation to a second fixation, at least two positions on the stomach wall. However, the soft suspended connection to the stomach wall achieved by invaginating at least one adapted part of the device is preferred, where fibrotic stomach to stomach tissue helps to give a long term stable position.

[00172] Any kind of mechanical construction may be used. Any mechanical construction driven mechanically or hydraulically or any pneumatic construction may be used. Any motor or any pump or moving material changing form when powered may be used to achieve the simple goal of stitching a part of the stomach wall by moving at least two portions of the stomach wall away fim each other.

[00173] Any kind of hydraulic operation may be used. It will be appreciated thatinstead of hydraulic operation, pneumatic operation can be used, wherein air instead of hydraulic fluid is moved between a rservoir and a chamber formed by the stitching device. leferably the rservoir has a locking position to keep it in the desired position if it is handled by the patient ' compass the rservoir it preferably stays compressed and releases after pressing again

[00174] Any kind of hydraulic solution may be used for the stitching device. 'Ihe hydraulic solution may be driven by both mechanically and powered with any motor or pump as well as manual.

[00175] Of course just expanding an in-vaginated part of the stomach also stitches away the stomach wall which also may be achieved both mechanically, hydraulically, pneumatically and both being powered with a motor or pump or by manual fore.

Volume filling device fortmrating obesity

[00176] In addition the various embodiments the apparatus for tmating rflux can be adapted to additionally trat obesity that's based on volume filling capacity of the distal part of elongated movement restriction device in the stomach that creates satiety. In the present context when volume filling device and its features, functionality and adaptations am discussed, itrefersto the distalpartof the elongated movement estriction device. Rease note that any feature, embodiment partof embodimentor method described herein may where applicable be used for both the distal or prximal part of the movement estriction device.

[00177] ihe following embodiment is based on the malization thatby invaginating a volume filling device (he reprsented by the distal part of the movement restriction device) by the stomach wall of the patient this inflatable object is protected fim the stomach acids and will thus main functioning for a very long time.

[00178] According to one embodiment of the invention, an apparatus to trat obesity and rflux of a patient having a stomach with a food cavity is provided, the apparatus comprising atleast one volume filling device adapted to be at least substantially invaginated by a stomach wall portion of the patient wherein the volume filling device is adapted to be placed on the outside of the stomach wall, so that the volume of the foo d cavity is reduced in size by a volume substantially exceeding the volume of the volume filling device, wherein the surface of the volume filling device comprises a biocompatible material, wherein a substantial part of the surface of the volume filling device is adapted to rest against the outside of the stomach wall, and wherein the volume filling device has a maximum circumference of at least 30 mm.

[00179] By invaginating the volume filling device by a stomach wall portion of the patient on the outside of the stomach wall, the volume filling device is protected fim the stomach acids, therby providing a device that will last for a long time.

[00180] 'The volume filling device is adapted to be placed with the outer surface of the volume filling device resting against the stomach wall, such that the volume of the food cavity is reduced in size by a volume substantially exceeding the volume of the volume filling device. 'Ihe volume filling device has a maximum cimrumfernce of atleast30 millimeters. Accordingly, the apparatus of the present invention is well suited for tmating obesity of an obese patient as well asrflux disease of the same patient his is advantageous, because rflux disease is a very common condition among human beings suffering fim obesity.

[00181] In accordance with a fist option, the volume filling device is adapted to be placed inside the stomach with the outer surface of the volume filling device resting against the inside of the stomach wall.

[00182] In accordance with a second option, the volume filling device is adapted to be placed outside the stomach with the outer surface of the volume filling device resting against the outside of the stomach wall.

[00183] referably, the volume filling device is adapted to be completely invaginated by the stomach wall of the patient and to be placed inside or outside the stomach wall via a gastrscopic instrument I this end the volume filling device may comprise an attachment device adapted to co-operate with a gripping instrment Suitably, the volume filling device is adapted to be non-invasively adjustable postoperatively.

[00184] The apparatus may comprise a fixation device, suitably two or more fixation devices, adapted to be involved in the fixation of the volume filling device to the stomach wall. The volume filling device may comprise a holding device adapted to be held by an instrument suitably two or mor holding devices, to simplify the implantation of the device.

[00185] Atleast a part of the volume filling device may be made of a material which is not destructible by stomach acid. The volume filling device may be destructible by acids, for example hydrochloric acid.

[00186] In an embodiment the volume filling device is inflatable to an expanded state and comprises an enclosure wall defining a chamber, wherein the volume filling device is inflated with a gel or fluid supplied into the chamber. At least one tube maybe connected to the volume filling device for supplying gel or fluid to the chamber. An injection port connectible with the tube may be provided. Altematively, the volume filling member may be provided with an inlet port for a fluid or a gel connectible to a gastroscopic instrment wherein the inlet port comprises a fluid connection adapted to interconnect the inflatable device and the gastroscopic instrument

[00187] The volume filling device may include a homogenous material, such as gel having a Shore value of less than 15. The device may also be a solid body.

[00188] The volume filling device may comprise a rigid, elasic or flexible outer surface. Where the outer surface is rigid, itis rigid enough to maintain non deformed when subject to foes cmated by stomach movements. The volume filling device may comprise a flexible non-elasic material.

[00189] In accordance with a fist general design of the volume filling device, the device has a maximum circumfernce as seen in a plane perpendicular to an axis though the device. The circumfernces of the device as seen in other planes perpendicular to said axis am equal to the maximum circumference or decrease as seen along said axis in the dicion fm the maximum circumference. Fbr example, the device may be substantially egg shaped, spherically shaped, or substantially shaped like an egg with an indented middle section or like a bent egg.

[00190] In accordance with a second general design of the device, the cimrumfernce of the device as seen in a plane perpendicular to an axisthough the device increases and decreases atleast two times as the plane is displaced along said axis, or decreases and increases atleast one time as the plane is displaced along said axis. Fbr example, the device may be substantially shaped like akidney.

[00191] The volume filling device has an elongated, rounded, bent and/ or curved shape.

[00192] The volume filling device has a circumfernce of atleast120, 150, 180 or 220 mm.

[00193] The volume filling device has a volume in the range of 0.0001 to 0.001 m3 , or0.00001 to 0.001 m3, or0.00001 to 0.0002 m3.The volume of the volume filling device has a volume of less than 0.0002 m3.

[00194] The volume filling device may comprise at least two inteconnectable portions adapted to be placed inside or outside the stomach as separate portions.

[00195] The volume filling device may comprise an elastic material, a bio compatible material and/ or silicone.

[00196] Suitably, the volume filling device is provided with a coating. Fbr example, a arylene coating, a polytetrafluoroethylene coating or a polyurethane coating. The coating may be amulti-ayer coating. The volume filling device may comprise an outer surface layer of polyurethane, 'flon@, or PIFE, or a combination therof.

[00197] The volume filling device may comprise a fluid adapted to be transformed into solid state or fixed form. Such a fluid maybe liquid polyurethane or iso-tonic. The fluid may comprises large molecules, such as iodine molecules, to prevent diffusion.

[00198] The volume filling device may have a maximum circumference of at least50 millimeters, preferably atleast80millimeters. Suitably, the volume filling device is deformable to a maximum diameter, so as to be insertable into a laparoscopic trocar.

[00199] lrferably, the volume filling device is adapted to be keptin place by stomach-o-stomach suturs or staples to invaginate the device in the stomach wall. Advantageously, the volume filling device has varying circumference to better be kept in place invaginated in the stomach wall of the patientThe stomach-to stomach suturs or staples may be provided with fixation portions exhibiting a structure adapted to be in contactwith the stomach wall to promote growth in of human tissue to secum long term placement of the volume filling device attached to the stomach wall. The structum may comprise a netlike structum.

[00200] In embodiment of the invention, the apparatus also comprises a stretching device placed outside the stomach wall and adapted to stitch a portion of the stomach wall, therby affecting the patient s appetite. When the volume filling device is inflatable, the apparatus may comprise a fluid connection inteconnecting the stitching device and the volume filling device.

[00201] In an embodiment the apparatus comprises a stitching device comprising atleast one operable stitching device implantable in an obese patient and adapted to stitch a portion of the patient s stomach wall and an operation device for operating the stitching device when implanted to stretch the stomach wall portion such that satiety is created.

[00202] In an embodiment the apparatus comprises atleast one operable stretching device implantable in the patient and adapted to stitch a portion of the patient s stomach wall, and an implantable control unit for automatically conrolling the operable stitching device, when the controlunit and stitching device am implanted, to stitch the stomach wall portion in connection with the patient eating such that satiety is created.

[00203] In an embodiment the apparatus comprises a stitching device comprising atleast one operable stitching device implantable in an obese patient and adapted to stitch a portion of the patient s stomach wall, wherein said stoetching device comprising an expandable stitching rservoir and an operation device for operating the stitching device when implanted to strich the stomach wall portion, wheein the at least the distal part of the movementrestriction device is inflatable and in fluid connection with said stretching reservoir, wherein said operation device comprises a pump for pumping fluid between said mainrservoir and said stitching reservoir to stitch said stomach wall portion such that satiety is heated. A control device may be provided for conrolling said strtching device including said pump. 'The control device may comprise a wireless rmote control adapted to control the stitching device fim the outside of the patient s body, or an implantable control unit for conrolling said stitching device. Altemaively, the control device may comprise a subcutaneously placed switch orrservoir adapted to contml the stitching device fim the outside of the paiens body. A sensor or sensing device to be implanted in the patient body maybe provided, wherein the implantable controlunitis adapted to control the strtching device fimthe inside of the paien s body using informaon fim said a sensor or sensing device, adapted to sense, director indimet the food intake of the patient

[00204] In an embodiment the distal part of the movement estriction device comprises a mainvolume filling reservoir, a strtching device comprising atleast one operable strtching device implantable in an obese patient and adapted to strtch a portion of the patient s stomach wall, wherein said strtching device comprising an expandable reservoir, adapted to be invaginated in the stomach wall at the upper part of the stomach, higher up than the inflatable main volume filling device when the patient is standing, wherein the volume filling device is inflatable and in fluid connection with said strtching reservoir, wherein normal contractions of the stomach wall, slated to food intake, cause fluid to flow fim said invaginated main volume filling rservoir lower placed onto the stomach wall adapted to cause said strtching rservoir to strtch said stomach wall portion such that satiety is heated. The fluid connection between the main volume filling rservoir and the strtching rservoir comprises a non-eturn valve. 'Ihe fluid connection between the main volume filling rservoir and the strtching rservoir comprises a release function adapted to release the volume in the stitching rservoir back to the main volume filling rservoir. Said release function may comprise a fluid mturn connection of a substantially smaller ama than said fluid connection, to slowly release back fluid to said main volume filling device mservoir fim the stretching rservoir to release said stitching of the stomach wall portion A further manual control device comprising a subcutaneously placed reservoir adapted to control the strtching device fom the outside of the patients body maybe provided to further affect the stretching device to stitch the stomach wall portion

[00205] In an embodiment the a main volume filling reservoir adapted to be inflatable may be provided, wherein the distal part of the movement estriction device further comprises an expandable structure, adapted to expand, when the device is invaginated in the stomach wall, wherein said structum comprising a bellow adapted to take into accountthe fibrosis sunmunding the device when implanted, such that the movement of the bellow is substantially unaffected of fibrosis.

[00206] In an embodiment the apparatus comprises a stitching device comprising at least one operable stitching device implantable in an obese patient and adapted to stitch a portion of the patient s stomach wall and wherein the stoetching device comprising a expandable structure, adapted to expand and stitch the stomach wall portion, when the device is invaginated in the stomach wall, wherein said structum comprising a special bellow adapted to take into account the fibrosis surrounding the device when implanted, such that the movement of the bellow is substantially unaffected of said fibrosis. An operation device for operating the stretching device may be provided to stretch the stomach wall portion such that satiety is heated. 'The apparatus may comprise an implantable control unit for automatically contrlling the operable stretching device, when the control unit and stretching device am implanted, to stretch the stomach wall portion in connection with the patient eating such that satiety iscreated.

[00207] In an embodiment the apparatus comprises a stretching device comprising at least one operable stretching device implantable in an obese patient and adapted to stretch a portion of the patienf s stomach wall such that satiety is heated. The control device may comprise a wireless rmote control adapted to control the stretching device fom the outside of the patient s body or an implantable control unit for conrolling said stitching device. Alternaively, said control device may comprise a subcutaneously placed switch orreservoir adapted to control the stretching device fim the outside of the paien s body. A sensor or sensing device adapted to be implanted in the patient body maybe provided, wherein the implantable controlunitis adapted to control the stitching device fim the inside of the paienfs body using information fim said sensor or sensing device, adapted to sense, director indict,the food intake of the patient

[00208] In an embodiment the apparatus is adapted to trateflux disease. I this end, it further comprises an implantable movement estricion device having an elongated shape with a proximal part and a distal part, the proximal part being adapted to be atleast partly invaginated by the patient s stomach fundus wall and having an outer surface thatincludes a biocompanible material. A substantial part of the outer surface of the proximal part of the movementrestriction device is adapted to rst against the stomach wall without injuring the latter in a position between the patient s diaphragm and at least a portion o f the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient s stomach towans the patient s diaphragm isrstricted, when the proximal part of the movement restriction device is invaginated, to therby prvent the cardia fim sliding through the patient s diaphragm opening into the patienf s thorax, so as to maintainthe supporting prssum against the patient s cardia sphincter muscle exerted fom the patient s abdomen,. 'The proximal part of the movementrestriction device has a size of atleast 125 mm3 and a cirumference of atleast 15 mm.T'he distal part stabilizes and holds the proximal part and is adapted to be substantially invaginated in the stomach wall.

[00209] In another embodiment the apparatus is adapted to trat flux disease. I this end, it further comprises an implantable movementrestriction device having an elongated shape with a proximal part and a distal part and having an outer surface including a biocompatible material. The proximal part of the movement restriction device is adapted to rst with at least a part of its outer surface against the patienfs stomachfundus wall, in a position between the patients diaphragm and the fundus wall, such that movement of the cardiac notch of the patienf s stomach towards the patient s diaphragm isrstricted, when the movement estriction device is implanted in the patient to therby prevent the cardia fim sliding through the patient s diaphragm opening into the patienf s thorax, so as to maintain the supporting prssum against the patient s cardia sphincter muscle exerted fim the patient s abdomen, wherein the proximal part of the movement restriction device having a size of at least 125 mm3 and a circumference of at least mm. An affixation device adapted to secum the proximal part of the movement restriction device in said position, when the movementrestriction device is implanted. The distal part stabilizes and holds the proximal part and is adapted to be substantially invaginated in the stomach wall

[00210] In another embodiment the apparatus is adapted to tmat flux disease. ' this end, it further comprises an implantable movementrestriction device having an elongated shape with a proximal part and a distal part and having an outer surface thatincludes a biocompatible material, the proximal partbeing adapted to be atleast partly invaginated by the patient s stomach fundus wall., A substantial part of the outer surface of the proximal part of the movementrestriction device is adapted to rest against the stomach wall without injuring the latter in a position between the patient s diaphragm and at least a portion of the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient s stomach towards the patient s diaphragm isrstricted, when the movement estriction device is invaginated, to therby prevent the cardia fim sliding through the patient s diaphragm opening into the patient s thorax, so as to maintain the supporting prssum against the patient s cardia sphincter muscle exerted fiom the patient s abdomen, the movement restriction device having a size of at least 125 mm3 and a circumference of at least 15 mm, further comprising a stitching device comprising at least one operable stitching device implantable in the obese patient and adapted to stitch a portion of the patienf s stomach wall such that satiety is heated. The distal part stabilizes and holds the proximal part and is adapted to be substantially invaginated in the stomach wall.

[00211] In another embodiment the apparatus is adapted to tmat flux disease. I this end, it further comprises an implantable movementrestriction device having an elongated shape with a proximal part and a distal part and having an outer surface including a biocompatible material. The proximal part of the movement restriction device is adapted to rst with at least a part of its outer surface against the patienf s stomach fundus wall, in a position between the patient s diaphragm and the fundus wall, such that movement of the cardiac notch of the patienf s stomach towards the patient s diaphragm isrstricted, when the movement estriction device is implanted in the patient to therby prevent the cardia fimm sliding through the patient s diaphragm opening into the patient s thorax, so as to maintainthe supporting prssum against the patient s cardia sphincter muscle exerted fim the patient s abdomen, wherein the movementrestriction device having a size of atleast 125 mm3 and a circumference of at least 15 mm, and a fixation device adapted to secum the movementrestriction device in said po sition, when the movement estriction device is implanted. The distal part stabilizes and holds the proximal part and is adapted to be substantially invaginated in the stomach wall. The apparatus further comprises a stitching device comprising at least one operable stretching device implantable in the obese patient and adapted to stitch a portion of the patient s stomach wall such that satiety is cmated.

[00212] In an embodiment the apparatus further comprises a stitching device comprising thee or mom mechanical parts engaged with different parts of the stomach wall, one parteach, wherein said engagementincludes suturing or stapling to the stomach wall or invaginating the mechanical parts in the stomach wall part with stomach to stomach sutures, wherein the there or mom mechanical parts am adapted to move in elation to each other adapted to stitch there different wall portions, the stitching device further adapted to having said wall portions stoetched independently fom each other both mgarding force used for stitching the stomach wall portion as well as, time periods the stitching is applied, and when the stitching is applied.

[00213] In an embodiment the apparatus further comprises a stitching device comprising two or mom hydraulic parts engaged with different parts of the stomach wall, one part each, whemein said engagementincludes suturing or stapling to hydraulic part to the stomach wall or invaginating the hydraulic parts in the stomach wall part, with stomach to stomach sutures, whemein the two or mor hydraulic parts am adapted to move in elation to each other adapted to stitch

there different wall portions, the stitching device further adapted to having said wall portions stitched independently fom each other both mgarding force used for stretching the stomach wall portion as well as, time periods the stitching is applied, and when the stitching is applied.

[00214] In an embodiment the apparatus further comprises a stitching device is engaged with a part of the stomach wall, including suturing or stapling the stretching device to the stomach wall or invaginating the stretching device in the stomach wall part, with stomach to stomach sutures, wherein the stitching device is further adapted to stitch a stomach wall portion controlling force used for stitching the stomach wall portion as well as, time periods the stitching is applied, and when the stitching is applied.

[00215] In an embodiment the apparatus further comprises a stitching device comprising two parts engaged with different parts of the stomach wall, one part each, wherein said engagementincludes suturing or stapling the parts to the stomach wall or invaginating the parts in the stomach wall part, with stomach t stomach sutures, wherein the stretching device further adapted to have different wall portions stmtched independently from each other controlling force used for stretching the stomach wall portion as well as, time periods the stretching is applied, and when the stretching is applied.

[00216] In an embodiment the apparatus further comprises an extemal control unit for contrlling the distal part of the movement estriction device from the outside of the patient s body. 'The extemal contml unitmay comprise a wireless remote control adapted to control the device from the outside of the patient s body. Alternatively, the extemal control unit may comprise a subcutaneously placed switch or rservoir adapted to control the device from the outside of the patient s body.

[00217] In an embodiment the apparatus further comprises a sensor or sensing device adapted to be implanted in the patient body, wherein the implantable control unit is adapted to contml the device from the inside of the patient s body using information from said a sensor or sensing device, adapted to sense, director indict,the food intake of the patient

[00218] In accordance with another aspect of the present invention, there is provided an apparatus for rating a rflux disease and obesity of an obese patient having a stomach with a food cavity, the apparatus comprises an implantable movement estriction device having a proximal part and a distal part, wherein the distal partis adapted to be atleast substantially invaginated by a stomach wall portion of the patient and having an outer surface that includes a biocompatible material, wherein the distal part of the movement restriction device is adapted to be placed inside the stomach with the outer surface of the volume filling device resting against the inside of the stomach wall, such that the volume of the food cavity is reduced in size by a volume substantially exceeding the volume of the volume filling device. The distal part of the movement restriction device has a maximum cimrumfernce of at least 30nillimeters.

[0001] h one embodiment of the apparatus, at least one of the movement restriction device segments has atleast one flat surface. preferably, atleastone of the movement restriction device segments has the shape of a polyhedron, preferably one of the following shapes: tetrahedron, hexahedron, octahedron, dodecahedron and icosahedrons.

[0002] In one embodimentof the apparatus, a friction enhancing material is provided. Ihis increases the friction between adjacent movement estriction device segments, therby stabilizing the movement estriction device. Ihis friction enhancing material is preferably a glue or an adhesive. Alternatively, atleast one of the movement estriction device segments has a surface with a rugged textume.

[0003] h one embodiment of the apparatus, at least one of the movement restriction device segments has spherical shape. Alternatively, it has at least one flat surface.

[0004] hI an alternative embodiment the apparatus comprises a fluid for reducing the friction between adjacent movement estriction device segments. The movement restriction device can therby mom easily adaptits shape to the movements of the patient's body.

[0005] The apparatus may in one embodimentcomprise a friction reducing material on the outer surface of the volume filing device segments. Ihis friction reducing material may be a fluid reducing the friction between adjacent movement restriction device segments.

[0006] The apparatus may comprise an expandable second movementrestriction device segment for enclosing two or mo fist movement estriction device segments different fim the second movement restriction device segment, wherein the second movement restriction device segment and the fist movement estriction device segments together forn the movement estriction device. In one alternative, the second movement restriction device segment comprises a friction reducing material on an inner surface thereof, the friction reducing material being in contact with the fist movement estriction device segments, when implanted.

[0007] The second movementmstriction device segment may be adapted to be filled with a fluid to allow mutual movement between adjacent first movement restriction device segments so that the shape of the movement estriction device adapts to stomach wall movements, when said movement estriction device is invaginated in a stomach wall. It is then prfered that at least a wall portion of the second movement estriction device segment is flexible or stmtchable.

[00219] The fluid provided in the movement estriction device maybe isotonic or hypertonic.

[00220] The movement estriction device segments maybe adapted to be inserted into a pouch formed by part of a stomach wall of the patient The movementrestriction device segments may be adapted to be filled, dimctly or indirectly, into the pouch formed by part of a stomach wall of the patientvia a tubular instrument

[00221] In one embodiment, the movement restriction device comprises a solidifying liquid.

[00222] This liquid or fluid may be supplied to the pouch by means of a conduit

[00223] In one embodiment, the plurality of movement restriction device segments am adapted to be interonnected to form the movementmrstriction device, after said plurality of movement restriction device segments have been inserted into a human or artificial pouch

[00224] In one embodiment, the movement restriction device segments am adapted to be assembled to an implantable movementmrstriction device.

[00225] 'The movement estriction device segments a preferably adapted to form an implantable movement estriction device of a controlled size.

[00226] An operational method to be combined in any way using any apparatus, part of apparatus or system or part of system or any claimed embodimentdescribed anywhere inthisdocument

[00227] A method or part of method to be used in any combination and using any apparatus or part of apparatus or any featum in any combination where the following method steps is applicable , whemein said method may comprise one or mom of the following operational method steps:

• introducing an instrument into the that

• passing down the esophagus,

• placing an anvil or unit for delivery of fixating members in the esophagus between the cardia and the diaphragmlevel, for engaging in the fixation of the esophagus to the stomach tissue,

• passing down the esophagus and additionally further down into the

stomach,

• filling the stomach with gas to expand the stomach,

• sucking fluid fnm the stomach,

• looking at a guiding vision when said instrument comprising a camera,

• engaging the instrument with the stomach,

• crating and suturing atleast one pouch of the stomach wall,

• filling said at least one pouch with a fluid and/ or volume filling device or

two or mom volume filling devices,

• deliver a plurality of volume filling devices into said pouch created in the

stomach tissue through a tubular member,

• passing through the stomach wall with said instrument

• passing through the stomach wall with said instrument for the placement of

a volume filling device on the outside of the stomach wall,

• passing through the stomach wall with said instrument for the placement of

a tube allowing placement of a subcutaneous injection port,

• placing an subcutaneous injection port,

• suturing or stapling the stomach wall fim the inside therof to the

esophagus,

• suturing or stapling the stomach wall to stomach wall fom the inside of the

stomach,

• engaging the instrument with the esophagus,

• suturing or stapling one layer of stomach tissue to one layer of esophageal

tissue,

• suturing or stapling two layers of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling there layers of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling four layers of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling one or mom layers of stomach tissue to two or mor

positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in rlation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a fist point along a fist esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance fim said fist esophagus surface length axis, radially inrlation to said esophagus center axis,

• delivering fixating members by a unit placed on said instrument,

• penetrating atleast one layer of stomach tissue and one layer of

esophagus tissue with said fixating members,

• placing said fixating members above the gastro-esophagealjunction for crating a tunnel between the esophagus and stomach above said junction,

• placing an esophagus part in the esophagus and a stomach part in the

stomach,

• placing the fixating member substantially between the stomach and

esophagus part,

• inserting said instrument into the main stomach cavity through the cardia

and adapted to direct the instrumentin cranial dimection to reach a position of said unit above said junction,

• allowing the tunnel a substantially unestricted contraction and release of the cardia closing sphincter muscle placed in said junction, when such a tunnel has beencreated.

[00228] A method or part of method to be used in any combination and using any apparatus or part of apparatus or any featum in any combination where the following method steps is applicable, wherein said method comprises one or mom of the following operational method steps:

• cutting the skin of a patient

• crating an opening in the abdominal wall of the patient

• Introducing said instrument into the abdominal cavity through said opening

in the abdominal wall,

• engaging the instrument with the stomach,

• pulling down into the stomach wall for crating at least one pr-shaped

pouch of the stomach wall,

• clamping the stomach wall for creating atleast one pr-shaped pouch of the stomach wall,

• suturing or stapling at least one pouch in the stomach wall,

two or mom volume filling devices,

• deliver a plurality of volume filling devices into said pouch created in the stomach tissue through a tubular member,

• passing through the stomach wall into the stomach with said instrument,

• passing through the stomach wall with said instrument for the placement of a volume filling device on the inside of the stomach wall,

• passing though the stomach wall with said instrument for suturing the stomach wall to the esophagus wall,

• placing a volume filling device on the outside of the stomach wall,

• invaginating said volume filling device in the stomach wall

• placing a subcutaneous injection port;

• suturing or stapling the stomach wall to stomach wall fim the outside of

the stomach,

• suturing or stapling the stomach wall to stomach wall fim the outside of

the stomach without penetrating the mucosa,

• suturing or stapling two layers of stomach wall to one or two layers of

stomach wall,

• engaging the instrument with the esophagus,

• clamping the on both sides of the esophagus for fixating one layer of

esophageal wall to stomach tissue,

• clamping the on both sides of the esophagus and the stomach fundus wall

for fixating one layer of esophageal wall to one or two layers of stomach tissue,

• introducing a tube or a gastroscopic instrument into the esophagus comprising an anvil member or a fixating delivery member involving in the fixation of the esophagus to the stomach,

• coordinating the position of the anvil member or a fixating delivery member inside the esophagus to said instrument clamping around the esophagus,

• suturing or stapling one layer of stomach tissue to one layer of esophageal

tissue,

• suturing or stapling two layers of stomach tissue to one layer of esophageal tissue,

• suturing or stapling there layers of stomach tissue to one layer of esophageal tissue,

• suturing or stapling four layers of stomach tissue to one layer of

esophageal tissue,

• stapling using staplers of different stapling depths at different positions in

a stapler row,

• stapling stomach to esophagus with one fist stapler depth and stapling

stomach to stomach with a second smaller stapler depth,

• stapling a pouch with stomach to stomach suturs in a staplerrow, further

comprising stapling the esophagus with staplers of a larger depth included as a part of said staplerrow,

• suturing or stapling one or mom layers of stomach tissue to two or mor

positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in elation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a fist point along a fist esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance fim said fist esophagus surface length axis, radially in elation to said esophagus center axis,

• delivering fixating members by a unitplaced on said instrument

• penetrating at least one layer of stomach tissue and one layer of esophagus tissue with said fixating members,

• placing said fixating members above the gastro-esophagealjunction for

crating a tunnel between the esophagus and stomach above said junction,

• allowing the tunnel a substantially unestricted contraction and release of

the cardia closing sphincter muscle placed in said junction, when such a tunnel has beencreated,

• placing an esophagus part in the esophagus and a stomach part in the

stomach via an introduction into the stomach cavity,

• placing the fixating member substantially between the stomach and

esophagus part,

• inserting said instrument into the main stomach cavity below said junction

and adapted to direct the instrument in cranial direction to mach a po sition of said unit above said junction,

• operating a joint comprised in said instrument ,for enabling said

instrument to be inserted into the main stomach cavity bending said jointin a direction to ach a position of said part of the unit in the esophagus above said junction.

[00229] A method or part of method to be used in any combination and using any apparatus or part of apparatus or any featum in any combination where the following method steps is applicable, wherein said method comprises one or mom of the following laparuscopic operational method steps:

• cutting the skin of a patient

• intrducing a tube though the abdominal wall,

• filling a fluid or gas into the abdominal cavity,

• intrducing two or mo trcars into the abdominal cavity,

• intrducing a camera into the abdominal cavity though one of the rcas,

• introducing said instrumentinto the abdominal cavity though a rcar,

• engaging the instrument with the stomach,

• pulling down into the stomach wall for crating atleastone pr-shaped pouch of the stomach wall,

• clamping the stomach wall for crating atleastone pr-shaped pouch of

the stomach wall,

• suturing or stapling at least one pouch in the stomach wall,

• filling said at least one pouch with a fluid and/ or a volume filling device

or two or mom volume filling devices,

stomach tissue though a tubular member,

• passing through the stomach wall into the stomach with said instrument

• passing through the stomach wall with said instrument for the placement of

a volume filling device on the inside of the stomach wall,

• passing through the stomach wall with said instrument for suturing the stomach wall to the esophagus wall,

• placing a volume filling device on the outside of the stomach wall,

• invaginating said volume filling device in the stomach wall

• placing a subcutaneous injection port

• suturing or stapling the stomach wall to stomach wall fim the outside of

the stomach,

• suturing or stapling two layers of stomach wall to one or two layers of stomach wall,

• suturing or stapling the stomach wall to stomach wall fim the outside of

the stomach without penetrating the mucosa,

• engaging the instrument with the esophagus,

• clamping the on both sides of the esophagus for fixating one layer of

esophageal wall to stomach tissue,

• clamping the on both sides of the esophagus and the stomach fundus wall

• introducing a tube or a gastroscopic instrumentinto the esophagus comprising an anvil member or a fixating delivery member involving in the fixation of the esophagus to the stomach,

• suturing or stapling one layer of stomach tissue to one layer of esophageal

tissue,

• suturing or stapling four layers of stomach tissue to one layer of

esophageal tissue,

a stapler row,

• stapling stomach to esophagus with one fist stapler depth and stapling

stomach to stomach with a second smaller stapler depth,

• stapling a pouch with stomach to stomach suturs in a staplerrow, further

• suturing or stapling one or mom layers of stomach tissue to two or mor

• delivering fixating members by a unit placed on said instrument

• placing said fixating members above the gastro-esophageal junction for

crating a tunnel between the esophagus and stomach above said junction,

• allowing the tunnel a substantially unestricted contraction and release of

• placing an esophagus partin the esophagus and a stomach partin the

stomach via an introduction into the stomach cavity,

• placing the fixating member substantially between the stomach and

esophagus part,

• inserting said instrument into the main stomach cavity below said junction

and adapted to dimct the instrumentin cranial direction to mach a position of said unit above said junction,

• operating a joint comprised in said instrument ,for enabling said

instrument to be inserted into the main stomach cavity bending said joint in a dincion to ach a position of said part of the unit in the esophagus above said junction

[00230] Rease note that any embodiment or part of embodiment as well as any method or part of method or any apparatus or part of apparatus or any feature or part of featum or any system or part of system or any figure or part of figure could be combined in any applicable way. All examples herein should be seen as part of the general description and therefor possible to combine in any way in general terms.

[00231] It should be noted that any embodiment or part of embodiment or featum or method or associated system or part of system described herein may be combined in any combination

Brief description of drawings

[00232] 'Ihe present invention will now be described in mor detail by way of non-limiting examples, and with refernce to the accompanying drawings, in which

[00233] FIgs. 1A-C am schematic views of various embodiments of an apparatus for tmating Gastro esophageal Reflux Disease implanted in a human patient

[00234] FIgs. 2A-B am schematic views of various embodiments of an apparatus for tmating Gastro ophageal Reflux Disease implanted in a human patient

[00235] FIgs. 3A-B ar schematic views of various embodiment of an apparatus for tmating Gastro esophageal Reflux Disease implanted in a human patient

[00236] Hgs. 4D-B am schematic views of embodiments of an apparatus for tmating Gastro-esophageal Reflux Disease and obesity implanted in a human patient

[00237] Hg. 5 is a schematic view of an embo diment of an apparatus for tmating Gastru-esophageal Reflux Disease implanted in a human patient

[00238] Hgs. 6A-D and 7-9 show alternative shapes of a movement estriction device for tmating Gastr Fsophageal Reflux Disease adapted to be implanted in a human patient

[00239] Hg. 10 is an overall view of a patient with an implanted movement estriction device for tmating Gastr Fsophageal Reflux Disease.

[00240] Hgs. 11 - 27 am schematic views of various ways of powering an apparatus for tmating Gastr Fsophageal Reflux Disease.

[00241] Hgs. 28 - 34 am schematic views of various ways of arranging the hydraulic or pneumatic powering of an apparatus of the invention for treating Gastr Fsophageal Reflux Disease.

[00242] Hg. 35 is a flowchartillustrating steps performed when implanting a movement estriction device for tmating Gastm esophageal Reflux Disease.

[00243] Hgs. 3641 show methods for estoring the location of the cardia and the fundus in a patient suffering fim Gastr esophageal Reflux Disease.

[00244] Hgs. 4246 show different shapes and features of a flux tmatment device comprised in an apparatus according to the invention,

[00245] Hgs. 47a-d show a deflated inflatable flux tmatmentdevice comprised in an apparatus according to the invention and an instrument for placing the flux tmatment device on the outside of the stomach wall of the patient

[00246] Figs.-48a-i-illustrate different steps of invaginating the inflatable device of Fig. 47a on the outside of a stomach wall of a patient.

[00247] Fig. 49a shows an embodiment wherein the reflux treatment apparatus is also adaptable to treat obesity and comprises a plurality of movement restriction device segments.

[00248] Fig. 49b shows an embodiment wherein the plurality of movement restriction device segments is provided in a pouch created by part of the stomach wall without any containing outer layer.

[00249] Fig. 49c shows an embodiment similar to the one shown in Fig. 49b but wherein proximal part of the combined reflux and obesity treatment apparatus has a different composition from the distal part the combined reflux and obesity treatment apparatus.

[00250] Figs. 50-51 show an embodiment wherein the reflux treatment apparatus adaptable also for treating obesity.

[00251] Figs. 52a-h illustrate different steps of invaginating the inflatable device of Fig. 47a on the inside of a stomach wall of a patient.

[00252] Figs 53a-c shows an instrument for creating an invagination of the wall of the stomach.

[00253] Figs. 54-55 show an abdominal method for treating reflux disease.

[00254] Fig. 56 is a schematic block diagram illustrating an embodiment of the reflux disease apparatus of the invention, in which wireless energy is released from an external source of energy for use in the power of a stimulation device.

RECTIFIED SHEET (RULE 91)

[00255] Hg. 57 is a schemaic block diagramillustraing another embodiment of the invention, in which wireless energy is released fim an intemal souce of energy.

[00256] Hgs. 58 to 61 am schematic block diagrams illustrating four embodiments, respectively, of the invention, in which a switch is implanted in the patient for dimctly or indiectly switching the power of the stimulation device.

[00257] Hg. 62 is a schematic block diagramillustrating conceivable combinations of implantable components for achieving various communication options.

[00258] Hg. 63 illustrates the apparatus in accordance with the invention implanted in a patient

[00259] Hg. 64 is a block diagramillustrating rmote control components of an embo diment of the invention.

[00260] Hgs. 65-68 am views of embodiments of an apparatus for tmating obesity by stitching the wall of the stomach that can be combined the rflux tmratment apparatus implanted in a human patient

[00261] Hg. 69 is a general description of the surface structum of any implanted device of the invention

[00262] Hg. 70-76 am views of various embodiments of an apparatus for tmating obesity that can be combined with therflux tmatment apparatus implanted in a human patient.

[00263] Hgs. 77-93 show various ways of powering an apparatus for mating obesity that can be combined with an apparatus for tmating rflux implanted in a human patient

[00264] Hgs. 94-100 show various ways of arranging hydraulic or pneumatic powering of an apparatus for tmating obesity implanted in a human patient

[00265] Hgs 101-105 show various instruments for tmating rflux and obesity.

[00266] Hgs 16-107 show methods for surgery for rating rflux and obesity.

[00267] Hg. 108 shows an embodiment of the movement estriction device in segments before assembly.

[00268] Hg. 109 shows an embodiment of the movementrestriction device when fist part and second part ar assembled.

[00269] Hg. 110 shows the embodiment of g. 109 when a third and a fourth part is assembled.

[00270] Hg. 111 shows the embodiment of Hg. 110 when assembling the final part

[00271] Hg. 112 shows the embodiment ofHgs. 108-111 when finally assembled.

[00272] Hg. 113a shows the com partof the embodimentof Hg. 108 with the operation channels.

[00273] Hgs 113b to 113f show crss sectional views of the com part of Hg. 113a according to planes It -I;, II-IIV-V, respectively.

[00274] Hgs. 114 and 115 show alteraiive embodiments of the device as shown in Hg. 108.

[00275] Hgs. 116a-d illustrate the insertion of the movementrestriction device segments shown in Hg. 114 by means of an instrument

[00276] Hgs. 117a-c illustrate a pmfered method of invaginating a plurality of movement estriction device segments into a stomach wall using an instrument

[00277] Hg. 118 illustrates an alternative instrument for invaginating a plurality of movement estriction device segments.

[00278] Hgs. 119a-e illustrate different shapes of movementrestriction devices when using a plurality of movementrestriction device segments to form a movement estriction device.

[00279] Hg. 120 is a sectional view of a movement estriction device comprising fluid.

[00280] Hg. 121 is a sectional view of amovement restriction device defining a plurality of movement estriction device segments.

[00281] Hg. 122 is a view of a movement restriction device comprising a plurality of movement restriction device segments contained in a fluid.

[00282] Hg. 123 is a sectional view of a movement restriction device defining a plurality of movement estriction device segments contained in a fluid.

Description of embodiments

[00283] As used herein, the term "segment" should be construed broadly to define any of the parts into which something can be divided.

Movement estriction device

[00284] Hg. 1A is a schematic view depicting an apparatus 11, including a movement restriction device 10 of a biocompatible material, for tmating rflux disease, in accordance with the invention, implanted in a human patient In Ig. 1A, the device 10 is invaginated in the fundus. 'The device 10 comprises a body 13 having an outer surface 15 suitable forresting against a portion of the outside wall 16a of the stomach fundus wall 16 in a position between the patient s diaphragm 18 and at least a portion of the lower part of the invaginated stomach fundus wall 16. Thus, with the device 10 invaginated in this fashion, movement of the cardiac notch of the patient s stomach towards the patient s diaphragm is restricted, therby the cardia is prvented fim sliding though the patient s diaphragm opening into the patient s thorax 20 and the supporting prssume against the patient s cardia sphincter muscle exerted fim the patient s abdomen is maintained

[00285] The body 13 is inflatable and adapted to be inflated with a gel or fluid. A fluid or gelreceiving member forreceiving fluid to inflate said movement estriction device may be provided. Alternatively, the body 13 includes a homogenous material and be a solid body. Alternatively, the body 13 includes an outer wall in the form of an enclosure wall defining a chamber. The outer wall may be rigid, elastic or flexible. Where the outer wall is rigid, itis rigid enough to maintain non-deformed when subject to foes created by stomach movements.

[00286] The body 13 of the movementrstriction device 10 can be affixed to the wall 16a of the fundus 16 in a number of different ways. Intheembodiment shown in Ig. 1A, the device 10 is invaginated in the fundus stomach wall fim outside the stomach After invagination, a first fixation device consisting of a number of stomach-to-stomach suturs or staples 22a is applied to keep the invagination in tact in the short term. This allows the growth of human tissue to keep the invagination in tact over the long term.

[00287] There may optionally be a second fixation device consisting of a number of sutures or staples 22b that ar provided between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 to hold the device 10 in said position between the paent's diaphragm 18 and atleasta portion of the lower part of the invaginated stomach fundus wall 16. 'hus, the device 10 is affixed in this position by this second fixation apparatus. A director indict affixaion of the device 10 to the diaphragmmuscle 18 or other muscle issue may be provided. As an alternative, a direct or indict affxaion of the device 10 to the esophagus His can be provided. Altemaively, or additionally, there may be a third fixation device in the form of suturs or staples 22c provided between the wall 16a of the fundus 16 and the diaphragm18 to hold the device 10 in said position

[00288] Hgum 1B shows an embo diment substantially similar to the one shown in gur 1A. In figure 1B the body 13 and invagination ar, in addition to the affixation 22, fixed by means of suturs and/ or staples 22c between therflux body 13 and the diaphragm 18, to hold the device in position above the cardia 14.

[00289] Hgum 1C shows another embo diment substantially similar to the one shown in figure 1A. In figure 1C therflux tmatment device is held in place by stomach-o-stomach sutures or staples 22a thatconnects the wall 16a of the fundus

16 to the wall 16a of the fundus 16. In addition the flux tmatment device 10 is held in place by suturs 22b or staples fim the wall 16 of the fundus 16a to the wall of the esophagus 24a, and by suturs or staples fom the wall of the fundus 16a to the diaphragm.

[00290] An alternative embodiment of an apparatus 17 for the tmatment of rflux disease in accordance with the invention is depicted in Hg. 2A. his embodiment is, in many aspects, similar to the one described above withreference toIHg. 1A-C. 'Ihus, a movementrestriction device 10 is shown implanted in a human patient and invaginated in the fundus. However, in the embodiment shown in Hg. 2A, the device 10 is invaginated fim the inside of the stomach, instead of fim outside of the stomach, as in ig. 1A-C. 'The movementrestriction device 10 comprises a body 13 adapted to mest against a portion of the inside wall of the stomach fundus wall 16 in a position between the paien s diaphragm 18 and at least a portion of the lower part of the invaginated stomach fundus wall 16. In this embodiment the body 13 is situated above the cardia ama 14 of a standing human or animal mamnial patient The body 13 of the device 10 is shaped to rest against the wall 16a of the fundus 16, and further, has an outer surface 15 suitable to mst againstthis fundus wall. hus, with the device 10 invaginated in this fashion as described above in connection with Hg. 1A, movement of the cardiac notch of the patienf s stomach towards the paiens diaphragm isrstricted, thereby the cardia is prvented fim sliding through the patient s diaphragm opening into the patient s thorax 20 and the supporting prssum againstthe patient s cardia sphincter muscle exerted fim the patient s abdomen is maintained.

[00291] After invagination, a number of stomach-to-stomach suturs or

staples 33a comprising a fist fixation device am applied fiminside the stomach 16 to keep the invagination intact in the short term. his allows the growth of human tissue, keeping the invagination intact over the long term. Additional suturs or staples 22b comprising a second fixation device can be provided between a wall portion 16b of the fundus 16 forming part of the invagination of the device 10 and the wall 24a of the esophagus 24 to hold the device 10 in said position. Similarly, a third fixation device in the form of suturs or staples 22c can be provided between another wall portion 16c of the fundus 16 forming pait of the invagination of the device 10 and the diaphragm18 to hold the device 10 in said position.

[00292] An alternative embodiment is shown in Hgur 2R his embodiment is in many aspects similar to the one described withreference toIHg 2A. However, here the sutures and staples 22b and 33a am all connected to the fixator of the rflux tmatmentdevice 10. his embodimentlacks stomach-to-diaphragm suturs or staples.

[00293] An alternative an apparatus 19 for the tmatment of flux disease is depicted in Hg. 3A. his alternative is in many aspects similar to the ones described above with refernce to Igs. 1A-C and 2 A-B. 'hus, a movement estriction device 10 is shown implanted in a human patient The device 10 comprises a body 13 adapted to rst against a portion of the stomach fundus wall 16 in a position between the patients diaphragm 18 and stomach fundus wall 16. However, in this alternative, the device 10 is not invaginated in the stomach 16. Instead, the affixation of the device 10 comprises an attachment structure 10a, preferably a net like-structum that is adapted to be in contact with the fundus stomach wall 16a to promote the growth of human tissue to secue long term placement of the rflux disease tmatment device attached to the stomach wall. In the short term, a fist fixation device in the form of suturs or staples 44a may be provided between the attachment structure 10a and the fundus wall 16a to keep the attachment structum 10 a in place.

[00294] The attachment structu 10Oa maybe adapted for a second fixation device in the form of suturs or staples 44b that ar provided between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 to hold the device 10 in said position between the patient's diaphragm 18 and stomach fundus wall 16. Similary, the attachment structum 1 Oa may also be adapted for a thin fixation device in the form of sutures or staples 44c that ar provided between the wall 16a of the fundus 16 and the diaphragm 18, again, to hold the device 10 in said position.

[00295] An alternative embodiment is shown in Hgur 3R is embodiment is in many aspects similar to the one described with reference to iHg 3A. In this embodiment, the rflux tmatment device 10 is, like in figum 2A-Binvaginated fom the inside of the stomach The attachmentstructum 10a is positioned on the wall 16a of the fundus 16 above and around the invagination created by the rflux tmratmentdevice 10.

[00296] Aalteimative embodimentofanapparatus21 fortmratmentofrmflux disease in accordance with the invention is depicted in Hg. 4A. hisembodimentis in many aspects similar to the one described above withreference toIHg. 1A-C. In Hg. 4A, a view of a device 10 for tmatmentofrflux disease in accordance with the invention is shown implanted in a human patient In Hg. 4A, the movement estriction device 10 is again invaginated in the fundus 16. The device 10 comprises a body 13 having an outer surface 15 suitable forresting against a portion of the outside wall 16a of the stomach fundus wall 16 in a position between the patient s diaphragm 18 and at least a portion of the lower part of the invaginated stomach fundus wall 16. The body 13 is shaped to rst against the outside wall 16a of the fundus 16. Thus, with the device 10 invaginated in this fashion, movement of the cardiac notch of the patient s stomach towards the patient s diaphragm is restricted, therby the cardia is prvented fim sliding through the patient s diaphragm opening into the patient s thorax 20 and the supporting prssum against the patient s cardia sphincter muscle exerted fim the patient s abdomen is maintained.

[00297] In the embodiment of Hg. 4A, as in the embodiment of Hg. 1A, after invagination of the device 10 in the fundus 16, a first fixation device consisting of a number of stomach-o-stomach sutues or staples 22a is applied to keep the invagination intact in the short term. A second fixation device consisting of a number of sutures or staples 22b is provided to hold the device 10 in said position between the patient s diaphragm 18 and at least a portion of the lower part of the invaginated stomach fundus wall 16. Additionally, a third fixation device in the form of suturs or staples 22c maybe provided between the wall 16a of the fundus 16 and the diaphragm 18, again, to hold the device 10 in said position

[00298] In the embodiment depicted in Ig. 4A, the size of the movement estriction device 10 can be rgulated while being implanted. The device 10 is associated with a hydraulic rservoir 52 connected to the device 10 by a lead 52b, whereby a non-invasive rgulation can be performed by manually pressing the meservoir 52. The device 10 is, in tum, connected to one or mom smaller chambers b.

[00299] Fbrthermor, the embodiment above may altematively be used to also tmat obesity. The apparatus may, in his embodiment be adapted to tmat obesity by using the volume of the movement restriction body 13 to contain a fluid, and further using one or mom smallerchambers 10b connected to the body 13 with a pump to be filled with fluid to stretch the fundus wall to crate satiety. The small chambers 1Ob a also adapted to be invaginated to in the fundus stomach wall, and when filled with fluid, an expansion occurs thatresults in human sensor feedback crating satiety. By placing the small hydraulic rservoir/ pump subcutaneously in the patient the patient is able to pump hydraulic fluid to fill the small chambers to feel full on quest

[00300] An altemative embodiment is shown in figure 4R his embodiment is substantially similar to the one shown in figum 4A but differs in how the rflux tratmentdevice 10 and chambers 10b a controlled. Here, the chambers 10b a not controlled by a subcutaneous pump but a powered intemal control unit 56. The intemal control unit 56 comprises means for the patient to control the device 10 in how it shall be used regarding treatment of flux and/ or obesity. It may also comprise means of supplying power to the device.

[00301] The intemal contrl unit56 may comprise a battery 70, an electric switch 72, a motor/pump 44, a rservoir 52, and an injection port1001. An energy transmission device 34 with a mmote control is adapted for conrolling and powering the device. The items being selected depending on the circumstances, e.g. if the device is electrically, hydraulically, pneumatically or mechanically operated.

[00302]

[00303] The conrl unitmay receive inputfim any sensor 76, specially a pressum sensor. Any type of sensor may be supplied. The intemal control unit 56 preferable includes intelligence in forms of a IGA or MCU or ASIC or any other cimuit component or memory (Fbr a mom extensive description see below under "system').

[00304] Hgum 4C shows essentially the same as figum 4A with the difference thatther is one small chamber 10b instead of two small chambers as in 4A. Hgum 4C shows the small chamber 10b in its empty state whereas figum 4D shows the small chambers 10b when ithas been filled and enlarged to create satiety.

[00305] Yet an alternative embodiment of an apparatus 23 for the treatment of rflux disease in accordance with the invention is depicted in Hg. 5A. his embodiment is, again, in many aspects similar to the one described above with refernce to IHg. 1A-C. 'Ihus, as in the embodiment of Hg. 1A, a movement estriction device 10, which is invaginated in the fundus, is comprised of a body 13 having an outer surface 15 suitable forresting against a portion of the outside wall 16a of the stomach fundus wall 16 in a position between the patient's diaphragm 18 and at least a portion of the lower part of the invaginated stomach fundus wall 16. The body 13 of the device 10 is shaped to restagainstthe outside wall 16a of the fundus 16 and has a generally smooth outer surface 15 suitable forresting against this fundus wall. And, again, after invagination of the device 10 inthe fundus 16, a first fixation device consisting of a number of stomach-to-stomach suturs or staples 22a isappliedto keep the invagination intactin the shortterm. A second fixation device consisting of a number of sutures or staples 22b applied between the wall 16a of the fundus 16 and the wall 24a of the esophagus 24 is provided to hold the device 10 in said position.

[00306] In the alternative embodiment shown in g. 5A, the apparatus 23 further comprises a stimulation device 26 for sending out simulation pulses adapted to stimulate the cardia muscle to further close the cardia to additionally prevent rflux disease. The apparatus 23 comprises atleastone conductor26a and atleast one electrode 26b adapted toreceive the simulation pulses.

[00307] The stimulation device 26 preferably comprises an electronic circuit and an energy source, which in the prfered embodimentis provided in the device 10.

[00308] The stimulation device 26 preferably sends stimulation pulses as a train of pulses, wherein the pulse train is adapted to be mpeated with a time break in between, the break extending the break between each pulse in the pulse train.

[00309] Hgum 5B shows essentially the same embodiment as in figum 5A, with the addition of an intemal contml unit 56, a mmote control 28 and an extemal energy transmission device 34. The intemal control unit 56 is connected to the stimulation device with a power lead 56b.The internal control unit 57 may comprise a battery 70 and an electric switch 72 and other components described below under "system".

[00310] The rflux disease treatment device 10 can, in accordance with one embodiment of the presentinvention, be formed as a generally egg shaped body, as is shown inHg. 6A. 'Iherflux disease treatment device 10 can, in accordance with another embodiment of the present invention, also be formed as an egg or sphere shaped body with an indent in its middle, as is shown inHg. 6R'Therflux disease tmatment device 10 can, in accordance with yet another embodiment of the presentinvention, further be formed as a slightly bent egg shaped body as shown in Hg. 6C.

[00311] The rflux disease tmatment device 10 can, in accordance with a further embo diment of the present invention, be formed as a generally spherically shaped body, as shown in Hg. 6D.

[00312] As discussed above, the rflux tmatment device 10 is fixed in a position which is above the esophagus in a standing patient enable this, one embodiment of the rflux treatment shown in Hgum 7 comprises a fixator 10d that may, for example, serve as an attachment point for suturs or staples. The fixator may be a loop or a ridge with or withoutholes or have any other shape thatmakes it suitable for fixating the rflux tmatment device 10.

[00313] Hgum 8 show an embodiment of the flux tmatment device 10 where itis adjustable by a hydraulic mean, and 10e is an injection portwhere hydraulic fluid can be in order to expand the device. Alternaively, in one embodiment the rflux tmatment device 10 can be inflated fim a small size to a larger size during a surgical prcedum where it is advantageous that the device is initially of small size, for example during a laparuscopic prcedue. In such an embodiment any filling material, solid, liquid or gas many injected trough the injection port 10e in order for the flux tmatment device 10 to achieve its final shape.

[00314] Hgum 9 shows an embodiment where the reflux tmatment device has a sunken ridge 10f adapted to being held with a surgical tool. Ihis is to be used, for example, during a surgical procedure when the flux tmatment device is implanted.

[00315] When the rflux disease tmatment device 10 is generally spherical, whereby it can be made to wholly or parly encompass the esophagus, the inner diameter D of the reflux disease tmatment device 10, is preferably such that it can encompass the esophagus and atleast a partof the fundus so that the device does not rest directly against the wall of the esophagus when implanted.

[00316] The movement restriction device 10 may take any form that enables the device 10 to rst in a po sition in which movement of the cardiac notch of the patient s stomach towards the patient s diaphragm is rstricted, therby the cardia is prvented fim sliding through the patient s diaphragm opening into the patient s thorax and the supporting prssum againstthe patient s cardia sphincter muscle exerted fim the patient s abdomen is maintained.

System

[00317] An energy and operation system, generally designated 28, to be incorporated in the apparatus according to the invention, will now be described with reference to Figs. 10-27.

[00318] The system 28 shown in Ig. 10 comprises an internal energy source in the form of an implanted energy transforming device 30 adapted to supply energy consuming components of the rflux disease tmatment apparatus with energy via a power supply line 32. An extemal energy transmission device 34 includes a wireless rmote control transmitting a wireless signal, which is received by a signalreceiver which may be incorporated in the implanted energy transforming device 30, orbe separate. The implanted energy transfoming device transformis energy fiom the signal into electric energy which is supplied via the power supply line 32.

[00319] Thesystem28of]Hg. 10 is shown in a mom generalized block diagram formin Hg. 11, wherin the paient's skin 36, generally shown by a vertical line, separates the interior of the patient 29 to the right of the line fim the exterior to the left of the line.

[00320] Hg. 11 shows a simplified block diagram showing the movement restricon device 10, the energy transforming device 30 powering the device 10 via power supply line 32, and the extemal energy transmission device 34.

[00321] Hg. 12 shows an embodiment of the invention identical to that of Hg. 11, exceptthata reversing device in the form of an electric switch 38 operable by polarized energy also is implanted in the patient29 forreversing the device 10. The wireless rmote control of the extemal energy transmission device 34 transmits a wireless signal that caries polarized energy and the implanted energy transforming device 30 transfoms the wireless polarized energy into a polarized current for operating the electric switch 38. When the polarity of the curentis shifted by the implanted energy transforming device 30 the electric switch 38 verses the function performed by the device 10.

[00322] Hg. 13 shows an embodiment of the invention identical to that of Hg. 11, exceptthat an operation device 40 implanted in the patientforrgulating the rflux disease tmatment device 10 is provided between the implanted energy transforming device 30 and the device 10. his operation device can be in the form of a motor 40, such as an electric servomotor. The motor 40 is powered with energy fiom the implanted energy transforming device 30, as the emote control of the extemal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy transforming device 30.

[00323] Hg. 14 shows an embodiment of the invention identical to that of Hg. 11, except that it also comprises an operation device is in the form of an assembly 42 including a motor/pump unit78 and a fluidreservoir 46 is implanted in the patient In this case the device 10 is hydraulically operated, i.e. hydraulic fluid is pumped by the motor/ pump unit44 fim the fluid reservoir 46 though a conduit48 to the device 10 to operate the device, and hydraulic fluid is pumped by the motor/ pump unit44 backfnim the device 10 to the fluid reservoir46 to mturn the device 10 to a starting position The implanted energy transforming device 30 transforms wireless energy into a current for example a polarized current for powering the motor/ pump unit44 via an electric power supply line 50.

[00324] Instead of a hydraulically operated movementmstriction device 10, it is also envisaged that the operation device comprises a pneumatic operation device. In this case, pressurized air can be used for mgulation and the fluid reservoir is placed by an air chamber and the fluid is placed by air.

[00325] In all of these embodiments the energy transforming device 30 may include a rechargeable accumulator like a battery or a capacitor to be charged by the wireless energy and supplies energy for any energy consuming part of the apparatus.

[00326] The extemal energy transmission device 34 is prferably wireless and may include armotely controlled control device for controlling the device 10 fim outside the human body.

[00327] Such a control device may include a wireless rmote control as well as a manual control of any implanted part to make contact with by the patient's hand mostlikely indimectfor example a buttn to press placed under the skin.

[00328] Ig. 15 shows an embodiment of the invention comprising the extemal energy transmission device 34 with its wireless rmote control, the device , in this case hydraulically operated, and the implanted energy transforming device 30, and further comprising a hydraulic fluid reservoir 52, a motor/ pump unit

44 and anreversing device in the form of a hydraulic valve shifting device 54, all implanted in the patient Of course the hydraulic operation could easily be performed by just changing the pumping dinction and the hydraulic valve may therefor be omitted. 'The emote control may be a device separated fim the extemal energy transmission or included in the same. The motor of the motor/ pump unit 44 is an electric motor. Inresponse to a control signal fm the wirelessrmote control of the extemal energy transmission device 34, the implanted energy transforming device 30 powers the motor/ pump unit44 with energy fim the energy carried by the control signal, whereby the motor/ pump unit44 distributes hydraulic fluid between the hydraulic fluid reservoir 52 and the device 10. The remote control of the extemal energy transmission device 34 controls the hydraulic valve shifting device 54 to shift the hydraulic fluid flow dinction between one dincion in which the fluid is pumped by the motor/ pump unit 44 fim the hydraulic fluid reservoir 52 to the device 10 to operate the device 10, and another opposite dincion in which the fluid is pumped by the motor/ pump unit 44 back fim the device 10 to the hydraulic fluid reservoir 52 to turn the device 10 to a starting

position.

[00329] HFg. 16 shows an embodiment of the invention identical to that of Fg. 15, except that an intemal control unit 56 contrlled by the wireless mmote control of the extemal energy transmission device 34, an accumulator 58 and a capacitor 60 also am implanted in the patient The intemal control unit 56 arranges storage of electric energy rceived fim the implanted energy transforming device 30 in the accumulator 58, which supplies energy to the device 10. Inresponse to a control signal fm the wirelessrmote control of the extemal energy transmission device 34, the intemal control unit 56 eitherreleases electric energy fim the accumulator 58 and transforms the released energy via power lines 62 and 64, or dimctly transforms electric energy fim the implanted energy transforming device 30 via a power line 66, the capacitor 60, which stabilizes the electric current a power line 68 and the power line 64, for the operation of the device 10.

[00330] The inemal controlunitis preferably programmable fiomoutside the patient's body. Ina prefered embodiment the inemal control unitis programmed to rgulate the device 10 to stitch the stomach according to a pe programmed time-schedule orto inputfiomany sensorsensing any possible physical parameter of the patient or any functional parameter of the device.

[00331] In accordance with an alternative, the capacitor 60 in the embodiment ofHg. 16 may be omitted. In accordance with another alternative, the accumulator 58 in this embodiment may be omitted.

[00332] Hg. 17 shows an embodiment of the invention identical to that of Hg. 10, except that a battery 70 for supplying energy for the operation of the device 10 and an electric switch 72 for switching the operation of the device 10 also am implanted in the patient The electric switch 72 is operated by the energy supplied by the implanted energy transforming device 30 to switch frm an off mode, in which the battery 70 is notin use, to an on mode, in which the battery 70 supplies energy for the operation of the device 10.

[00333] Hg. 18 shows an embodiment of the invention identical to that of Hg. 16, exceptthat an inemal control unit 56 controllable by the wireless rmote control of the extemal energy transmission device 34 also is implanted in the patient In this case, the electric switch 72 is operated by the energy supplied by the implanted energy transforming device 30 to switch frm an off mode, in which the wireless rmote control is pmvented fom controlling the eiemal control unit 56 and the battery is not in use, to a standby mode, in which the emote control is permitted to contml the intemal control unit 56 to release electric energy frm the battery 70 for the operation of the device 10.

[00334] Hg. 19 shows an embodiment of the invention identical to that of Hg. 17, except that an accumulator58 is substituted for the battery 70 and the implanted components am intemonnected differntly. In this case, the accumulatr 58 stores energy fim the implanted energy transforming device 30. Inresponse to a control signal fim the wireless rmote control of the extemal energy transmission device 34, the inemal control unit 56 controls the electric switch 72 to switch fom an off mode, in which the accumulator 58 is not in use, to an on mode, in which the accumulator 58 supplies energy for the operation of the device 10.

[00335] Hg. 20 shows an embodiment of the invention identical to that of Hg. 18, except that a battery 70 also is implanted in the patient and the implanted components am interonnected differntly. In response to a control signal fim the wireless rmote control of the extenal energy transmission device 34, the intemal control unit 56 controls the accumulator 58 to deliver energy for operating the electric switch 72 to switch fim an off mode, in which the battery 70 is notin use, to an on mode, in which the battery 70 supplies electric energy for the operation of the device 10.

[00336] Altemaively, the electric switch 72 may be operated by energy supplied by the accumulator 58 to switch fim an off mode, in which the wireless memote control is prvented fim controlling the battery 70 to supply electric energy and is notin use, to a standby mode, in which the wireless mote control is permitted to control the battery 70 to supply electric energy for the operation of the device 10.

[00337] Itshould be understood thatthe switchshould be interpreted inits broadest embodiment his means an IGA ora DA converteror any other electronic component or ciruit may switch power on and off preferably being controlled fim outside the patient's body or by an internal control unit

[00338] Hg. 21 shows an embodiment of the invention identical to that of Hg. 17, except that a motor40, a mechanicalreversing device in the form of a gearbox 74, and an inemal control unit56 for controlling the gearbox 74 also ame implanted in the patient 'The intemal conrl unit56 control the gearbox 74 to reverse the function performed by the device 10 (mechanically operated). Even simpler is to switch the diretion of themotor electrunically.

[00339] Hg. 22 shows an embodiment of the invention identical to that of Hg. 20 exceptthatthe implanted components am interconnected differently. hus, inthis case, the inemal contml unit56 is powered by the battery 70 whenthe accumulator 58, suitably a capacitor, activates the electric switch 72 to switch to an onmode. When the electric switch 72 is in its on mode the inemal control unit56 is permitted to control the battery 70 to supply, or not supply, energy for the operation of the device 10.

[00340] Hg. 23 schematically shows conceivable combinations of implanted components of the apparatus for achieving various communication options. Basically, there ae the device 10, the intemal conrl unit 56, motor pump unit 44, and the extemal energy transmission device 34 including the extemal wireless remote control. As almady described above the wireless rmote control transmits a conrl signal which is received by the intemal control unit 56, which in turn control the various implanted components of the apparatus.

[00341] A feedback device, prferably in the form of a sensor 76, may be implanted in the patient for sensing a physical parameter of the patient such as a contraction wave in the esophagus informing the patient is eating. Theintemal conrl unit56, oraltematively the extemal wireless rmote control of the extemal energy transmission device 34, may conrl the device 10 in response to signals frm the sensor 76. A transceiver maybe combined with the sensor 76 for sending information on the sensed physical parameter to the extemal wireless rmote control. The wireless rmote conrl may comprise a signal transmitter or transceiver and the internal conrl unit 56 may comprise a signal receiver or transceiver. Alternatively, the wireless rmote conrl may comprise a signal receiver or transceiver and the inemal conrl unit 56 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers may be used for sending information or data slated to the device 10 fm inside the patient s body to the outside therof.

[00342] Altemaively, the sensor 76 maybe arranged to sense a functional parameter of the device 10.

[00343] Where the motor/ pump unit44 and battery 70 for powering the motor/ pump unit 44 am implanted, the battery 70 may be equipped with a transceiver for sending information on the condition of the battery 70. 'bemome precise, when charging a battery or accumulator with energy feedback information slated to said charging process is sent and the energy supply is changed accordingly.

[00344] Ig. 24 shows an alternative embodiment wherin the device 10 is regulated fim outside the patient's body. The system 28 comprises a movement estriction device 10 connected to a battery 70 via a subcutaneous switch80. Thus, the rgulation of the device 10 is performed non-invasively by manually pressing the subcutaneous switch, whereby the operation of the device 10 is switched on and off. It will be appreciated that the shown embodiment is a simplification and that additional components, such as an eiemal control unit or any other part disclosed in the present application can be added to the system.

[00345] Ig. 25 shows an alternative embodiment, wherein the system28 comprises a movement restriction device 10 in fluid connection with a hydraulic fluid reservoir 52. Non-invasive rgulation is performed by manually pressing the hydraulic rservoir connected to the device 10.

[00346] A further embodiment of a system to be incorporated in the apparatus according to the invention comprises a feedback device for sending information fiminside the patient's body to the outside therof to give feedback information mlated to at least one functional parameter of the movementrestriction device or apparatus or a physical parameter of the patient thereby optimizing the performance of the apparatus.

[00347] One prfered functional parameter of the device is correlated to the transfer of energy for charging the intemal energy source.

[00348] In Ig. 26, an arrangement is schematically illustrated for supplying an accurate amount of energy to a system 28 implanted in a patient whose skin 36 is indicated by a vertical line. A movementrestriction device 10 is connected to an implanted energy transforming device 30, likewise located inside the patient preferably just beneath the patient's skin 36. Generally speaking, the implanted energy transforming device 30 may be placed in the abdomen, thorax, muscle fascia (e.g. in the abdominal wall), subcutaneously, or at any other suitable location 'The implanted energy transforming device 30 is adapted to receive wireless energy E transmitted fim an extemal energy source 34a provided in the extemal energy transmission device 34 located outside the patient's skin 36 in the vicinity of the implanted energy transforming device 30.

[00349] As is well known in the ar, the wireless energy E may generally be transferred by means of any suitable 'anscutaneous, hergy'Mansfer (TEI device, such as a device including a primary coil arranged in the extemal energy source 34a and an adjacent secondary coil arranged in the implanted energy transforming device30. When an electric curentis fed through the primary coil, energy in the form of a voltage is induced in the secondary coil which can be used to operate a movement restriction device, e.g. after storing the incoming energy in an energy storing device or accumulator, such as a battery or a capacitor. However, the present invention is generally not limited to any particular energy transfer technique, 'El'devices or energy storing devices, and any kind of wireless energy may be used.

[00350] 'The amount of energy received inside the body to the device may be compared with the energy used by the device. The term used by the device is then understood to include also energy stord by the device. Theamountof transfered energy can be rgulated by means of an extemal control unit 34b controlling the extemal energy source 34a based on the determined energy balance, as described above. In order to transfer the cornet amount of energy, the energy balance and the required amount of energy can be determined by means of an intemal controlunit56 connected to the rflux disease tmatment device 10. The intemal control unit 56 may thus be arranged toreceive various measurements obtained by suitable sensors or the like, not shown, measuring certain characteristics of the r1O, somehow rflecting the required amount of energy needed for proper operation of the device 10. Moreover, the current condition of the patient may also be detected by means of suitable measuring devices or sensors, in order to provide parametersrflecting the patient's condition Hence, such characteristics and/ or parametersmay be slated to the current state of the device 10, such as power consumption, operational mode and temperature, as well as the patient's condition rflected by, e.g., body temperature, blood prssume, heartbeats and breaking.

[00351] iRrhermor, an energy storing device or accumulator 58 may optionally be connected to the implanted energy transforming device 30 for accumulating received energy for later use by the device 10. Alternatively or additionally, characteristic of such an accumulator, also rflecing the requimed amount of energy, may be measured as well. The accumulator may be replaced by a battery, and the measured characteristics may be slated to the current state of the battery, such as voltage, temperatue, etc. In order to provide sufficientvoltage and currentto the device 10, and also to avoid excessive heating, itis clearly understood thatthe battery should be charged optimally by receiving a cormct amountof energy fim the implanted energy transforming device 30, i.e., nottoo litdeortoomuch The accumulator may also be a capacitor with corresponding characteristics.

[00352] Fbr example, battery characteristics may be measured on a regular basis to determine the current state of the battery, which then may be stord as state information in a suitable storage means in the intemal control unit56. hus, whenever new measumments am made, the stored battery state information can be updated accordingly. In this way, the state of the battery can be "calibrated" by transfeing a cormect amount of energy, so as to maintain the battery in an optimal condition

[00353] Thus, the intemal control unit 56 is adapted to determine the energy balance and/ or the curenly required amount of energy, (either energy per time unit or accumulated energy) based on measumments made by the above-mentioned sensors or measuring devices on the rflux disease treatment device 10, or the patient or an energy storing device if used, or any combination therof. The intemal control unit 56 is further connected to an intemal signal transmitter 82, arranged to transmit a control signalrflecting the determined required amount of energy, to an extemal signal receiver 34c connected to the extemal control unit 34b. The amountof energy transmitted fim the extemal energy source 34a may then be rgulated in response to the received control signal.

[00354] Altemaively, sensor measurements can be transmitted dimcty to the extemal control unit 34b wherein the energy balance and/ or the curenyrequimed amount of energy can be determined by the extemal control unit 34b, thus integrating the above-described function of the internal conrl unit 56 in the extemal conrl unit 34b. In that case, the intemal contml unit 56 can be omitted and the sensor measuments are supplied dimctly to the intemal signal transmitter 82 which sends the measumments over to the extemal signal rceiver 34c and the extemal conrl unit 34b. The energy balance and the curenty equied amount of energy can then be determined by the extemal control unit 34b based on those sensor measumments.

[00355] Hence, the present solution employs the feedback of information indicating the required energy, which is mor efficient than pmvious solutions because itis based on the actualuse of energy that's compared to the ceived energy, e.g. with respect to the amount of energy, the energy difference, or the energy receiving rate as compared to the energy rate used by the device 10. The device 10 may use the mceived energy either for consuming or for storing the energy in an energy storage device or the like. The different parameters discussed above would thus be used if relevant and needed and then as a tool for determining the actual energy balance. However, such parametersmay also be needed per se for any actions taken internally to specifically operate the device.

[00356] The internal signal transmitter 82 and the extemal signal receiver 34c may be implemented as separate units using suitable signal transfer means, such as radio, IR(Infrarmd) or ultrasonic signals. Altemaively, the intemal signal transmitter 82 and the extemal signal receiver 34c may be integrated in the implanted energy transforming device 30 and the extemal energy source 34a, respectively, so as to convey control signals in a verse dimetion relative to the energy transfer, basically using the same transmission technique. The control signals may be modulated with respect to frequency, phase or amplitude.

[00357] ' conclude, the energy supply arrangementillustrated in IFg. 26 may operate basically in the following manner. The energy balance is fist determined by the intemal control unit56. A control signal rflecting the requimed amountof energy is also coated by the intemal contml unit56, and the control signal is transmitted fnm the intemal signal transmitter 82 to the extemal signal receiver 34c. Altemaively, the energy balance can be determined by the extemal controlunit34b instead depending on the implementation, as mentioned above. In that case, the control signal may carry measurementresults fim various sensors. The amount of energy emitted fim the extemal energy source 34a can then be regulated by the extemal controlunit34b, based on the determined energy balance, e.g. in response to the received control signal. his process may be repeated intermittenly at certain intervals during ongoing energy transfer, or may be executed on a mom or less continuous basis during the energy transfer.

[00358] The amount of transferred energy can generally be rgulated by adjusting various transmission parametersin the extemal energy source 34a, such as voltage, current amplitude, wave fmquency and pulse characteristics.

[00359] A method is thus provided for controlling transmission of wireless energy supplied to an electrically operable rflux disease treatment device implanted in a patient The wireless energy E is transmitted fnm an extemal energy source located outside the patient and is received by an intemal energy receiver located inside the patient the intemal energy receiver being connected to the device 10 for dirctly or indimnecty supplying received energy therto. An energy balance is determined between the energyreceived by the intemal energy receiver and the energy used for the device 10. The transmission of wireless energy E fim the extemal energy source is then controlled based on the determined energy balance.

[00360] A system is also provided for conrolling transmission of wireless energy supplied to an electrically operable movement restriction device 10 irplantedina patient 'The systems adapted to transmit the wireless energy E frm an extemal energy source located outside the patient which is received by an implanted energy transforming device located inside the patient the implanted energy transforming device being connected to the device 10 for dimctly or indimectly supplying received energy therto. The systemis further adapted to determine an energy balance between the energyreceived by the implanted energy transforming device and the energy used for the device 10, and control the transmission of wireless energy E frm the extemal energy source, based on the determined energy balance.

[00361] The functional parameter of the device is cornelated to the transfer of energy for charging the intemal energy soure.

[00362] In yet an alternative embodiment the extemal source of energy is controlled frm outside the patient's body to release elecromagnetic wireless energy, and released elecromagnetic wireless energy is used for operating the device 10.

[00363] In another embodiment the extemal source of energy is controlling from outside the patient's body to release non-magnetic wireless energy, and released non-magnetic wireless energy is used for operating the device 10.

[00364] Tho se skilled in the art will realize that the above various embodiments according to Figs. 14-26 could be combined in many different ways. Fbr example, the electric switch 38 operated polarized energy could be incorporated in any of the embodiments ofFigs. 12, 15-21, the hydraulic valve shifting device 54 could be incorporated in the embodiment of Hg. 24, and the gearbox 74 could be incorporated in the embodimentof Hg. 33. Itshouldbe noted that the switch simply could mean any electronic circuit or component

[00365] Wireless transfer of energy for operating the movement estriction device 10 has been described to enable non-invasive operation It will be appreciated that the device 10 can be operated with wim bound energy as well. One such example is shown in Hg. 26, wherein an extemal switch 84 is interonnected between the extemal energy source 34a and an operation device, such as an electric motor rgulating the device 10, by means of power lines 86 and 88. An extemal control unit 34b contrls the operation of the extemal switch to effect prper operation of the device 10.

Hydraulic or pneumatic powering

[00366] Hgs. 28-31 show in mom detail block diagrams of four different ways of hydraulically or pneumatically powering a movementrestriction device according to the invention

[00367] Hg. 28 shows a system for rating rflux disease as described above with. The system comprises a device 10 and further a separate regulation rservoir 46, a one way pump 44 and an altemate valve 54.

[00368] Hg. 29shows the device 10 and a fluidreservoir 46. Bymoving the wall of the regulation reservoir or changing the size of the same in any other different way, the adjustment of the device may be performed without any valve, just fee passage of fluid any time by moving therservoir wall.

[00369] Hg. 30 shows the device 10, a two way pump 44 and the regulation rservoir 46.

[00370] Hg. 31 shows a block diagram of areversed servo system with a firstclosed systemcontolling a second closed system.Ihe servo system comprises a regulation rservoir 46 and a servo rservoir 90. The servo reservoir 90 mechanically contrls a movement restiriction device 10 via a mechanical interconnection 94. The device 10 has an expandable/ contactable cavity. his cavity is preferably expanded or contracted by supplying hydraulic fluid fim the larger adjustable rservoir 92 in fluid connection with the device 10. Altematively, the cavity contains compressible gas, which can be compressed and expanded under the control of the servo reservoir 90.

[00371] The servo rservoir 90 can also be part of the device itself.

[00372] In one embodiment thergulationrservoir is placed subcutaneous under the patients skin and is operated by pushing the outer surface therof by meansofafinger. his flux disease treatment system is illustrated in Hgs 32-c. In Hg. 31, a flexible subcutaneous rgulation reservoir 46 is shown connected to a bulge shaped servo rservoir 90 by means of a conduit48. hisbellowshaped servo reservoir 90 is comprised in a flexible movement restriction device 10. Inthe state shown in Hg. 32, the servo rservoir 90 contains a minimum of fluid and most fluid is found in the rgulationrservoir 46. Due to the mechanical interconnection between the servo rservoir 90 and the device 10, the outer shape of the device 10 is contracted, i.e., it occupies less than its maximum volume. his maximum volume is shown with dashed lines in the figure.

[00373] Hg. 32 shows a state wherin a user, such as the patientin with the device is implanted, passes the rgulation rservoir 46 so that fluid contained therin is brought to flow through the conduit 48 and into the servo reservoir 90, which, thanks to its bellow shape, expands longitudinally. his expansion in turn expands the device 10 so thatitoccupies its maximum volume, thereby sttching the stomach wall (not shown), which it contacts.

[00374] The rgulation rservoir 46 is preferably provided with means 46a for keeping its shape after compression his means, which is schematically shown in the figure, will thus keep the device 10 in a stitched position also when the user releases the rgulation reservoir. In this way, thergulationrservoir essentially operates as an on/ off switch for the flux disease tmatment system.

[00375] An alternative embodiment of hydraulic or pneumatic operation will now be described with reference toIgs. 33and34. The block diagram shown in Hg. 33 comprises with a fist closed system controlling a second closed system. The first system comprises a rgulation rservoir 46 and a servo rservoir 90. The servo rservoir 90 mechanically controls a larger adjustable rservoir 92 via a mechanical interconnection 94. A movement restriction device 10 having an expandable/ contactable cavity is in turn controlled by the larger adjustable rservoir 92 by supply of hydraulic fluid fiom the larger adjustable rservoir 92 in fluid connection with the device 10.

[00376] An example of this embodiment will now be described with referncetoHg. 34. like in the pmvious embodiment thergulation rservoir is placed subcutaneous under the patient's skin and is operated by pushing the outer surface therof by means of a finger. The rgulation rservoir 46 is in fluid connection with a bellow shaped servo rservoir 90 by means of a conduit48. In the firstclosed system46, 48, 90 shownin]ig. 32a, the servo mservoir90 contains a minimumoffluid and mostfluid is found inthergulation rservoir 46.

[00377] The servo mservoir 90 is mechanically connected to a larger adjustable rservoir 92, in this example also having a bellow shape butwith a larger diameter than the servo rservoir 90. The larger adjustable rservoir 92 is in fluid connection with the device 10. his means that when a user pushes the rgulation rservoir 46, therby displacing fluid fom the regulation rservoir 46 to the servo rservoir 90, the expansion of the servo rservoir 90 will displace a larger volume of fluid fim the larger adjustable rservoir 92 to the device 10. In other words, in this reversed servo, a small volume in thergulation rservoir is compressed with a higher force and this crates a movement of a larger total ama with less force per aea unit

[00378] like in the previous embodiment described above withrefernce to FIgs. 32a-c, the rgulation rservoir 46 is preferably provided with means 46a for keeping its shape after compression Ihis means, which is schematically shown in the figure, will thus keep the device 10 in a stitched position also when the user releases the rgulation reservoir. In this way, thergulationreservoir essentially operates as an on/ off switch for the flux disease tmatment system.

[00379] InHg. 35, a flow chartillustrating steps performed when implanting a device inaccordance withthe present invention Erstina step 102, an opening is cutin the abdominal wall. Next ina step 104 anama around the stomachis dissected. 'hermupon, in a step 106 at least one movement restriction device in accordance with the invention is placed in contact with the stomach wall, in particular the fundus wall. The stomach wall is then sutumd in a step 108.

Method for the restoration of the location of the cardia and the fundus

[00380] Hgum 36 sshos how an instrument 200 having atleast one flexible part 201 is introduced into the esophagus 24 of a patientthatis suffering fim a hiatal hernia 202 where a part of the esophagus 24 and fundus 16 that is supposed to be located below the diaphragm 18 has moved through the hiatus opening 18a to a position above the diaphragm18.

[00381] In figum 37 itis shown how, in a subsequent step, a member 203 having a larger cross sectional ama than said instrument 200 is released fim the instrument 200. The member 203 is adapted as to have a cross-sectional thatis larger than the opening of the cardia 14. Ihis can be achieved by radial expansion of the member 203. The instrument200 is then pushed in a proximal dimection so that the cardia 14 and the fundus 16, or part of fundus 16, incorrectly located above diaphragm18, slide through the hiatus opening 18a back to a cormct position below the diaphragm 18.

[00382] Hgum 38 shows an alternative method to the one shown in Hg. 37 which is an embodiment of the invention In many aspects, this figum is similar to fig 37. In figure 38, the instrument200 is adapted to release a balloon member 204 at the proximal end 205 of the instrument 200 in the lower part of the stomach 206, and using the balloon member 204 to push the instrument200 againstthe lower wall part of the stomach 207 so that the cardia 14 and the fundus 16 or part of fundus 16 slide through the hiatus opening 18a to a position below the diaphragm 18.

[00383] FIgure 39 shows yet an altemative method which is an embodiment of the invention Again, this figum is in many aspects similar to fig 37. However, in figum 39 the method involves attaching the member 203 to the wall of the stomach 207 by a fixation 208. As described above the instrument is then pushed in a proximal diction so the cardia 14 and the fundus 16 or, part of fundus 16, slides below the diaphragm18.

[00384] Hgur 40 shows how the fundus 16 and cardia 14 is located in a position below the diaphragm 18 after having been pushed through the hiatal opening 18a by the instrument 200.

[00385] Hgur 41 shows a subsequent step of the method. After the fundus 16 and cardia 14 has been pushed into its comet position below the diaphragm 18, the wall of the fundus 16a is affixe d to the lower part of the esophagus 24. his is carried out by using a member 209 in the proximal part 205 of the instrument 200 which is capable of providing suturs or staples 210. The fixation hinders the movement of the caria 14 and the fundus 16 to a position above the diaphragm 18.

[00386] Other methods according to the invention am briefly described below.

[00387] A method of tmating rflux disease of a patient comprises the step of implanting a rflux disease tmatment system according to the invention into the patient's body.

[00388] A method of using the system for rating rflux disease according to the invention comprises the step ofrgulating the device postoperatively to pmvent rflux.

[00389] A method for surgically placing a movement restriction device according to the invention in a patient comprises the steps of cutting an opening in the abdominal wall of the patient dissecting the ama around the stomach, placing a movement estriction device attached to the stomach wall, and suturing the stomach wall.

[00390] A method of using arflux disease treatment system, postoperatively contrlled fim outside the body, rgulating the device, comprises the steps of filling out a volume attached to a part of the stonach wall, and regulating the device fim outside the patient's body to affect the rflux of the patient

[00391] A method of using a movementrestriction device comprises the steps of filling out a volume in a firstpart of the stomach wall by placing a firstpart of the device, filling out a volume in a second part of the stomach wall by placing a second part of the device, andrgulating the devices fim outside the patient's body to affectthe rflux of the patient

[00392] A method of tmating rflux disease in a patient comprises the steps of inserting a needle or a tube like instrument into the abdomen of the paiens body, using the needle or tube like instrumentto fill the paienes abdomen with gas therby expanding the abdominal cavity, placing atleast two laparoscopic rocan in the paienes body, inserting a camera through one of the laparoscopic rocars into the paienfs abdomen, inserting atleast one dissecting tool though one of said atleasttwo laparoscopic rocars and dissecting an intended placement ama of at least one portion of the stomach of the patient placing a movement restriction device according to the invention on the stomach fundus wall, invaginating the device in the stomach fundus wall, suturing the stomach wall to itself to keep the device in place, suturing the fundus of the stomach towards the lower part of the esophagus, and preventing the cardia to slide up through the diaphragminto the thorax. Using the method and device as described herein will provide a tmatment of Gastro Fsophageal Reflux Disease which is very effective and which does not suffer fim complications such as damaging of tissue and undesind migration of non tissue into tissue.

[00393] The filling body of the device can be adapted to be pushed or pulled through a rocar for laparoscopic use, where the rocar has a diameter thatis smaller than the mlaxed diameter of the body. The filling body can include an outer wall and a hollow gas filled inner part that allows the body to pass through the frocar. Alternatively, the filling body can include an outer wall and a hollow fluid filled inner part that allow the body to pass through thetrocar. In this latter case, thefluidcanbeagel. The filling body can further include multiple parts that can be inserted into the r car, and that can then be put together into one unitay piece inside the patient s body, allowing the filling body to pass thmugh the trocar. The filling body can include an outer wall and a hollow compressed inner partthatis filled with a fluid or gel after insertion into the patient s body. The can further include an injection port that can be used to fill the filling body with a fluid after insertion into the patient's body through the injection port.

[00394] The filling body of the device can be an elastic compressible material, allowing the filling body to pass through the trocar. The filling body can be made fim a material that's softer than 25 shur, or even 15 shume.

[00395] The filling body can also include an outer wall substantially taking the shape ofa ball. The filling body can also include at least one holding device adapted to be used for pushing or pulling the filling body through a trocar for laparoscopicuse. The holding device can be adapted to hold a prolongation of the device that's adapted to be held by a surgical instrument The holding device can also hold a trad or band inserted through the holding device. The holding device can also beat least partly placed inside the outer wall of the filling body. Thefilling body of the device can prferably has a size that is larger than the intestinal outlet fim the stomach to avoid ileus if the ball, as a complication, should enter into the stomach leferably, the body has a smallest outer diameter between 30 mm and mmorlarger. preferably, the body has a smallest outer circumfernce between mm and 150 mm.

[00396] lrfered embodiments of a device for tmating rflux disease, a system comprising a device for tmating rflux disease, and a method according to the invention have been described. A person skilled in the artrealizes that these could be varied within the scope of the appended claims. hus, although the different features have been described in specific embodiments, it will be appreciated that they can be combined in different configurations when applicable. Fbr example, although hydraulic control has been described in association with the device configuration of fIg. 4 A-B, it can also be applied to the device configurations of Figs. 2 A-B and 3A-B.

[00397] It is important that the implanted rflux tmatment device is firmly kept in place in the stomach wall in which it is invaginated. I this end, therflux tmatment device can be provided with one or r momthmugh holes adapted for receiving suturs or staples used for fixation of the invagination. Such an embodimentis shown in Hg. 42, where therflux tmatment device 10 is provided with a row of holes 10i provided on a protruding flange-like protrusion on therflux tmatment device. In this embodiment the row of holes extend along the longitudinal axis of the rflux tmatment device.

[00398] Hg. 43 illustrates how suturs 314 a provided so thatthey run thmugh the stomach wall 12a and hmugh the holes 10i. Inthis way, therflux tmatment device is fixed in place in the pouch created fim the stomach wall and will thus be prvented fim sliding.

[00399] Although a plurality of holes is illustrated in the g. 42, itwill be appreciated that one single hole is sufficient to obtain improved fixation of the rflux tmratmentdevice 10.

[00400] Hg. 44 illustrates a rflux tmatment device provided with an inlet port 10h 'Therflux tmatment device is invaginated in the stomach wall and the inletport10his available forconnectionto a tube orthe like fmmthe abdominal ama of the patient

[00401] Hg. 45 illustrates an invaginated rflux tmatment device wherein, instead of an inlet port, a fixed tube 1Og extends into the abdominal ama of the patient

[00402] Hg. 46 is a figum similar to Hg. 44 but also illustrating tunneling of a connection tube 10g in the stomach wall between the inletport 10h and therflux tmratmentdevice 10.

[00403] It has been shown that the shape of the flux tmatment device can take many different forms. It will be appreciated that also the material of therflux tmatment device can vary. It is pmfened that the rflux treatment device is provided with a coating, such asaParylene, polytetrafluoroethylene (PLFE), or polyurthane coating, or a combination of such coatings, i.e., amulti-layer coating. his coating or multi-ayer coating improves the properties of therflux tmatment device, such as its rsistance to wear.

[00404] h one embodiment the flux tmatment device comprises an

inflatable device expandable to an expanded state. In this case, the inflatable device is provided with an inlet port for a fluid and is adapted to be connected to a gastroscopic instrument his embodiment will now be described in detail with refernce to Igs. 47a47d.

[00405] An inflatable rflux tmatment device in its non-expanded state is shown in Hg. 47a. Iis essentially a balloon-like, deflated device 10 having an inlet port 10h In this state, the inflatable device has a diameter of a fewmillimeters at the most, allowing it to be inserted into the stomach through the esophagus of the patient by means of a gastroscopic, tube-ike instrument 600, depicted in figure 47b. The instrument comprises an outer sleeve 600a and an inner sleeve 600b which can be displaced longitudinally relatively to the outer sleeve. The inner sleeve is provided with a cutter in the form of a cutting edge 615 at the distal end thermof. This cutting edge can be used for cutting a hole in the stomach wall, as will be explained in detail in the following.

[00406] When the instrumentraches a stomach wall, see Hg. 47c, the inner sleeve is brought forward fim its position in the outer sleeve and into contact with the stomach wall 12a. The cutting edge 615 of the inner sleeve then cuts a hole in the stomach wall so as to allow subsequent insertion of therflux tmatment device 10 into and through this hole, see Hg. 47d. In order to push therflux tmatment device through the hole, a piston602 maybe provided in the instrument Thus, the instrument further comprises a piston 602 adapted for pushing a deflated rflux tmatment device 10 out from a position in the inner sleeve, this position being shown in Hg. 47b, to a position outside of the inner sleeve, this being shown inHg. 47d.

[00407] In order to protect the deflated flux tmatment device 10 fim the cutting edge 615 of the inner sleeve, a further protective sleeve (not shown) can be provided around therflux tmatment device.

[00408] An intraluminar method of invaginating arflux tmatment device 10 on the outside of the stomach wall 12a will now be described withrefernce to FIgs. 48ai. Initially, an instrument 600, preferably a gastroscopic instrument is inserted into the mouth of the patient see Hg. 48a. The instrument comprises an injection device 601, 602 for injecting either fluid or a device into the stomach of the patient The instrument 600 further comprises a control unit 606 adapted for controlling the operation of the instrument I this end, the control unit 606 comprises one or moe steering devices, in the embodiment shown in the figum in the form of two joysticks 603 and two control buttons 604. A display 605 is provided for displaying the image provided by a camera (not shown) arranged at the outer end of the elongated member 607, see Igs. 48ei. The camera may be assisted by a light sour e (not shown).

[00409] The instrument is further inserted into the esophagus and into the stomach of the patient see g. 48b. By means of the instrument600, a hole 12b is crated in the wall of the stomach 12. I this end, the instrument is provided with one or mor cutters 615 at the distal end therof, for example in the way describe d above with refernce to Igs. 47a-d. These cutters can of course be designed in different ways, such as a toothed drum cutter rotating about the center axis of the tube-ike instrument The instrument 600 is hollow providing a space for therflux tmatment device 10 in its deflated state.

[00410] After cutting a hole in the stomach wall, the distal end of the instrument 600 is inserted into and thmugh the hole 12b so that it ends up outside the stomach wall 12a. his is shown in Hg. 48c, showing a side view of the stomach 12, and Hg. 48d, which is a sectional view though the stomach ofHg. 48c taken along the lines Vd - Vd. The deflated rflux tmatment device 10 is then inserted in the abdominal ama.

[00411] The instrument600 is adapted to cmate a "pocket" or "pouch" on the outside of the stomach 12 around the hole 12b in the stomach wall. Such an instrument and the method of providing the pouch will now be described.

[00412] FIgs. 48e-i shows a gastmscopic or laparoscopic instrumentfor invaginating a rflux tmatment device 10 in the stomach wall 12a of the patient by crating a pouch of stomach wall 12a material in which the flux tmatment device is placed. The instrument generally designated 600, and which may comprise the features described above with refernce toIgs. 47a-d, comprises an elongated member 607 having a proximal end and a distal end, the elongated member 607 having a diameter less than that of the patient's esophagus and being flexible such as to allow introduction of the flexible elongated member 607 with its distal end first though the patient's that esophagus and into the stomach 12 to the stomach wall 12a.

[00413] The stomach penetration device or cutter 615 is provided on the elongated member 607 atthe distal en therof for penetrating the stomach wall 12a so as to cmate a hole in the stomach wall 12a, to allow introduction of the elongated member 607 through the hole. 'Ihe stomach penetration device 615 could be adapted to be operable forrmracting said stomach penetration device

615 after the stomachfundus wall 12a has been penetrated, for not further damaging issue within the body. The instrument further comprises a special holding device 609 provided on the elongated member 607 on the proximal side to the penetration device 615.

[00414] The elongated member further comprises an expandable member 611 which is adapted to be expanded after the elongated member has penetrated the stomach wall 12a and therby assist in the craion of a cavity or pouch adapted to hold the rflux tmatment device 610. The expandable member 611 may comprise an inflatable circular balloon provided ciurnmferntially around the distal end portion of the flexible elongated member 60 7.

[00415] The method steps when invaginating therflux tmatment device will now be described in detail. After the instrument 600 has been inserted into the stomach 12, the stomach penetration device 615 is placed into contact with the stomach wall 12a, see Hg. 48e. 'Ihe stomach penetration device or cutter 615 is thenbroughtto create the hole 12b inthe stomachwall, wheeafter atleast the expandable member 611 is brought thmugh the hole 12b in the stomach wall. The specialholding device 609 isinthis step broughtto a holding state whereinit expands radially so as to form an essentially cirular abutment surface to the stomach wall 12a, see Hg. 48f. In this way, the insertion of the stomach penetration device 615 and the expandable member 611 hmugh the hole 12a in the stomach wall is limite d to the po sition sho wn in Hg. 48f.

[00416] The expandable member 611 is then expanded. In the case the expandable member comprises a balloon or the like, air or other fluid is injected into it

[00417] The part of the elongated member 607 comprising the expandable member 611 is then miracted in the proximal direction, as indicated by the anw in

Hg. 48g, therby pulling the stomach wall 612 into a basketlike structum coated by the special holding device 609.

[00418] A suturing or stapling device 608 is further provided, either as a device connected to the elongated member 607 or as a separate instrument The suturing or stapling member comprises a subring or stapling end 613 which is adapted to close the cavity or pouch by means of stomach to stomach suturs or staples 14.

[00419] In a further step, illustrated in Hg. 48h, an inflatable rflux tmatment device 10 is placed in its deflated state in the basketlike structure. The rflux tmatment device 10 is then inflated to its inflated or expanded state, see Hg. 48i. his inflation of the rflux tmatment device 10 can be accomplished by injecting a fluid or a gel into the deflatedrflux tmatment device. It can also be accomplished by injecting a material which is allowed to cue, therby forming a solid device 10. hus, the flux tmatment device 10 shown in gs. 48h and 48i can illustrate either a balloon-like device which is subsequently filled with fluid or gel or alternatively a material which is simply injected into the basket like structure formed by the stomach wall 12a.

[00420] The fluid which is used to fill the rflux treatment device 10 could be any suitable fluid suitable to fill the inflatable device 10, such as a salt solution In another embodiment when this fluid is a fluid which is adapted to be transformed into solid state, the fluid could be liquid polyurethane.

[00421] In order to minimize or entirely eliminate leakage, the fluid is iso tonic, i.e., it has the same osmolarity as human body fluids. Another way of prventing diffusion is to provide a fluid which comprises large molecules, such as iodine molecules.

[00422] The stomach-o-stomach sutures or staples a preferably provided with fixation portions exhibiting a structure, such as a net like structure, adapted to be in contactwith the stomach wall to promote growth in of human tissue to secume the long term placement of the rflux tmatment device attached to the stomach wall.

[00423] After the inflatable device 10 has been inflated, partly orfully, the inlet port 10b (not shown in Figs. 48h and 48i) of the rflux treatment device 10, is sealed and the instrument 600 is miracted fim the hole 12b, which is subsequently closed in some suitable way, such as by means of the instrument600. The instrument is then removed fim the stomach 600 and the inflatable device 10 in its inflated or expanded state is invaginated by a stomach wall portion of the patient on the outside of the stomach wall. During one or mom of the above described steps, the stomach may be inflated with gas, preferably by means of the gastroscopic instrument

[00424] The rflux tmatment device 10 described above withreference to Figs. 48a-i has beendescribed as aninflatable flux tmatment device. Itwillbe appreciated that is also can be an elastic eflux tmatment device with an elasticity allowing compression so as to be inserted into a gastroscopic instrument and which expands to an expanded state after leaving the instrument

[00425] The apparatus for tmating rflux can have the additional functionality of tmating obesity. In such an embodiment therflux tmatment device may be a volume filling device that fills a volume of the stomach and therby crating satiety.

[00426] Ihe embodiment shown in fig. 49a shows an elongated movement restriction device 310 having a proximal part 310' and a distal part 310".The device 310 is invaginated in the stomach wall with its proximal part 310' close to and at least partially above the patient's cardia 14 when the patient is in a standing position and is fixed to a position above the caria ama 14c by a fixation, such as sutures or staples 22. Fbr example a director indirect fixation to the diaphragm muscle or other muscle tissue may be provided. As an altemaive a dimct or indirect fixation to the esophagus above and close to the angle o His can be provided. In this embodiment the proximal part of the device 310' rsts in a po sition against stomach wall of the fundus when implanted and which also fills a volume above the cardia ama 14c between the cardia and the diaphragm muscle so that the cardia is prvented fiom slipping up into the thorax cavity, whereby rflux disease is prvented. The distal part 310" stabilizes and holds the proximal part and has sufficientlength to exert the stabilizing effect The distal part 310" also has a sufficient volume to reduce the food cavity volume and therby the device obtains an additional functionality of tmating obesity.

[00427] In this prfered embodiment the apparatus for tmating rflux disease comprises two or mom movementrestriction device segments adapted to form the movement estriction device 310. In this embodiment there a a plurality of spherical movement restriction device segments in the form of small balls which am contained in a movementrestriction device segment in the form of an outer layer or shell, which preferably is elastic or flexible. In this way, the outer layer can be inserted into the stomach as a separate part, which subsequently is filled with a plurality of small, preferably spherical or polyhedral movement estriction device segments. his method will be explained below with reference to Figs. 117a-c.

[00428] By providing a movement restriction device 310 with a plurality of movement restriction device segments, the movement restriction device 310 easily adapts to the movement of the stomach into which it is invaginated.

[00429] In an alternative embodiment, the small movement estriction device segments am inserted or injected into a pouch pmviously heated by part of the stomach wall of the patient without any collecting outer layer or shell. Ihis embodimentis illustrated in g. 49b and consponds to the method described below with reference toIHg. 117a-c.

[00430] In onler to provide a movement estriction device which is mor stable in the proximal part 310', thispart can be made of a different configuration fim the distal part 310". Thus, in an embodiment shown in Hg. 49c, the proximal part 310', which is fixed to a position above the cardia ama 14c, comprises a larger ball shaped part or segment, while the distal part 310" comprises a plurality of small movement restriction device segments. This embodiment combines the advantages of a stable proximal part 310' used for prventing rflux with a mor adaptable distal part310" used as a volume filling device for tmating obesity. Generally, the proximal and distal parts can have different configurations and contents, independent of each other. This content can be a mixtum of solid and fluid content, such as fiction enhancing orreducing fluid.

[00431] Such a device 310 may be used for keeping electronics and/ or an energy source and/ or hydraulic fluid. Hydraulic fluid fim that device may be distributed to several smaller inflatable device amas to vary the stitching ama fim time to time avoiding any possible mom permanent stitching effect of the stomach wall. Even mechanically several stitching amas may be used.

[00432] In an alternative embodiment, which is shown in Hg. 50, the volume of an inflatable rflux tmatment device 310 may be in fluid connection with one or mo preferably smaller inflatable devices or chambe 1Ob. These chamber am adapted to communicate with fluid or air being moved between the chambe.

[00433] Thus, the large chamber 310 is adapted to, with its main volume to be arflux tmatment device for reducing the size of the food cavity and for tmating rflux disease and the one or several small chamber am adapted to function as the inflatable devices to tmat obesity, wherein the main chamber is adapted to communicate with fluid or air to the small chambers causing a stretching effect in the stomach wall thereby further tmating obesity.

[00434] Ig 51 show an embodiment with a combination of a volume filling device invaginated in the central or lower portion of the stomach and a stitching device invaginated in the upper portion or fundus of the patients stomach These two devices serve to trat obesity.

[00435] The volume filling device 399 fills a volume of the stomach crating satiety. The stitching device stitches the wall of the stomach This stitches the tissue setting off an endogenous signaling that crates satiety. This mimics the stitching effect of filling the stomach with food. Thus, in Ig. 51 there is shown an adjustable volume filling device 399, which is invaginated in the stomach wall of a patient's stomach 312. Additionally, an adjustable stitching device 350 with the previously described function is invaginated in the stomach fundus wall of the patient Itis prfered that the volume filling device 399 is substantially larger than the stitching device 350.

[00436] The volume filling device 399 and the stitching device 350 can be adapted to tmat flux. In one embodiment the volume filling device and the stretching device am positioned to prevent the cardia 14 frm slipping upwards trough the opening of the hernia 18a to a position above the diaphragm 18.

[00437] The volume filling device 399 and the stitching device 350 am in fluid communication with each other via a fistfluid tube 352, in which a pump 354 is provided. The pump 354 is under the control frm an energy transforming device 330, which is adapted to supply the pump 350 with energy via a power supply line 356. The energy transforming device 330 is also connected to a sensor 319 provided in the esophagus of the patient so that foo d intake can be detected.

[00438] The rflux tmatment device 10 and the stitching device 350 am also in fluid communication with each other via a second fluid tube 358, which preferably has a smaller crss-sectional ara than the fist fluid tube 352.

[00439] ihe operation of this arrangement is as follows.The volume filling device 399 functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12. Additionally, when the stitching device 350 is enlarged by pumping fluid fim the volume filling device 10 and to the stitching device 350 by means of the pump 354, the stomach fundus wall is strtched, crating a feeling of satiety for the patient ihus, for example when food intake is detected by means of the sensor 319, fluid is automatically pumped into the stitching device 350 to increase the feeling of satiety and thereby limitthe food intake.

[00440] When fluid has been injected into the stitching device 350, the intemal prssum therein is higher than the intemal pressum in therflux tmatment device 399. his difference in prssum will cmate a flow of fluid in the second, preferably narrwer tube 358 fim the stitching device 350 to the flux tmatment device 399. The flow rate will be determined by among other things the difference in prssum and the crss-sectional ama of the second tube 358. Itis prfered that the second tube is so dimensioned, that the pressure in the volume filing device 399 and the stitching device 350 willturn to equilibrium after 3 hours after fluid has been injected into the stretching device 350 to cmate the feeling of satiety.

[00441] In this embodiment the function of the second tube 358 is to allow fluid to mturnifm the stretching device 350 to the volume filling device 399. Itwill be appreciated thatthis function also can be performed by the pump 354 in the fist tube 352 and that the second tube 358 then can be omitted.

[00442] Ig. 51b illustrates an embodiment similar to the one illustrated in Ig. 51a. hus, there is provided an adjustable volume filling device 310, which is invaginated in the stomach wall of a patient's stomach 312. Additionally, an adjustable stitching device 350 with the pmviously described function is invaginated in the stomach fundus wall of the patient It is prfered that the volume filling device 310 is substantially larger than the stitching device 350.

[00443] The volume filling device 310 and the stitching device 350 am in fluid communication with each other via a fist fluid tube 352, and a second fluid tube, which preferably has a smaller cross-sectional ama than the fist tube. However, instead of a pump, there is provided a non-eturn valve 360 in the first fluid tube 352 instead of an energized pump. Ihis non-eturn valve 360 allows fluid to flow in the direction frm the volume filling device 310 and to the stretching device 10 butnotvice verse. Ihis means thatthis embodimentmay be entirly non energized. Instead, it operates according to the following principles.

[00444] When the food cavity of the stomach 312 is essentially empty, there is a state of equilibrium between the intemal prssum of the volume filling device 310 and the stitching device 350. In this state, the stretching device is in a non stoetch state, i.e., it does not stmtch a part of the stomach fundus wall and thus does notcmeate a feeling of satiety.

[00445] When the patient starts to eat food will enter the food cavity of the stomach 312. Ihis will cmate increased prssum on the stomach wall in which the volume filling device 310 is invaginated and the intemal prssue therin will increase. Also, the stomach wall muscles will begin to process the food in the food cavity by contraction, which also contributes to an increased intemal prssum in the volume filling device 310.

[00446] Since the intemal prssum in the stitching device 350 will rain essentially unchanged, because it is located in the upper part of the stomach312 where no food is exerting a prssure on the stomach wall, a fluid flow will be created though the first and second fluid tubes 352, 358 in the dimetion fim the volume filling device 310 and to the stitching device 350. Ihisinturnwill increase the volume of the stitching device 350, which, by stitching the stomach fundus wall, will provide a feeling of satiety to the patient

[00447] A fluid flow fim the stitching device 350 to the volume filling device 310 though the second tube 358 will mturn the prssum of these devices to equilibrium as described above with refernce toIHg. 51a

[00448] Similarly, Hg.51c illustrates an embodiment wherein the stitching device 350 can be actively rgulated by manually pressing an adjustmentrservoir which is provided subcutaneously below the patients skin. hus, argulation reservoir 317 for fluids is connected to the inflatable device by means of a conduit 318 in the form of a tube. The stitching device 350 is therby adapted to be regulated, non-invasively, by moving liquid or air fim the rgulation reservoir 317 to the chamber formed by the inflatable device. The rgulation of the stitching device 350 preferably comprises a reversed servo, i.e., a small volume is actuated for example by the patient's finger and this small volume is in connection with a larger volume.

[00449] The volume filling device 310 preferably has an essentially round shape to not damage the stomach wall. An example therof is shown in Hg. 51-3a, wherein the volume filling device is essentially egg-shaped. In another prfered embodiment the volume filling device is slightly bent such as the embodiment shown in Hg. 51-3b. However, since the stomach wall is strong many different shapes, forms, and dimensions may be used. In one embodiment the volume filling device has a diameter of about 40 millimeters and a length of about 120 millimeters, rsulting in a volume that is about half the volume of the patient's stomach However, it is pferned that the maximumcimrumfemence of the volume filling device is at least 30 millimeters, moe preferably at least 50millimeters, and even mom preferably atleast80 millimeters.

[00450] It is not necessary that the volume filling device is elongated. In the embo diment shown in Hg. 51-3c, the volume filling device 310 is essentially spherical or ball-shaped. In order to fill out the stomach, two or mom such volume filling devices may be combined to achieve the desired decrease of the food cavity of the patient's stomach

[00451] It has been mentioned that the volume filling device is secured by the stomach-o-stomach suturs or staples. In order to further improve the fixation, the volume filling device may be provided with a waist portion having smaller diameter that the maximum diameter of the volume filling device. Such volume filling device having a waist portion 10 a is shown inHg.51-3d.

[00452] The volume filling device 10 may consist of at least two intemronnectable portions so that each portion is easier to insertinto the stomach

and further hmugh a hole in the stomach wall. hus, Hg. 51-3e shows a volume filling device comprising two mom or less spherical sub-parts 310b, 310c interconnected by a portion with which preferably has smaller diameter. The portion with smaller diameter may comprise an interconnection means with areversible function allowing subsequent disconnection of the two interconnected sub-parts 310b, 310c. Such means may comprise a bayonet socket a scew connection or the like, designated 310 d in the figure. Altemaively, the portion with smaller diameter may comprise a fixed interconnection, such as rsilient locking hooks provided on one of the sub-parts 310b, 310c and engaging the rim of a hole provided in the other one of the sub-parts 310b, 310c.

[00453] The configuration of the volume filling device 10 is not limited to one waist portion 310 a. hus, inHg. 51-3f a volume filling device with two waist portions is shown

[00454] In order to facilitate positioning of the volume filling device, an attachmentmeans in the form of a handle or the like may be provided on the outer surface of the volume filling device. One example thereof is shown in Hg. 51-3g, wheein also a detail view of a handle 51-10e is shown In a pfeed embodiment the attachment means is provide at an end portion of the volume filling device 310. In order to avoid protruding portion on the surface of the volume filling device 310, the handle 310e is provided flush with the outer surface of the volume filling device 310 and a ecess 310f is arranged to allow a gripping tool or instrument(not shown in Hg. 51-3g) to achieve firm gripping around the handle 310e.

[00455] The volume filling device may comprise a tube for filling or emptying the volume filling device of a fluid or gel. By injecting fluid or gel into the volume filling device 310, the volume filling device is inflated to an inflated state, as will be described below. The size of the volume filling device can also be adjusted by moving fluid or gel thefiom to a differentrseivoir.

[00456] A volume filling device 310 adapted for this is shown in Hg. 51-3h. A tube 310g is fixedly attached to the volume filling device. his tube can be attached to a suitable instrument (not shown) or an injection port, which will be explained in detail below.

[00457] Instead of having a fixedly attached tube, the volume filling device 310 may comprise an inletport 10h adapted for connection of a separate tube (not shown in this figure).

[00458] It is important that the implanted volume filling device is firmly kept in place in the stomach wall in which it is invaginated. I this end, the volume filling device can be provided with one or mor through holes adapted forreceiving suturs or staples used for fixation of the invagination. Such an embodiment is shown in Hg. 51-3j, where the volume filling device 310 is provided with a row of holes 10i provided on a protruding flange-ike protrusion on the volume filling device. In this embodiment the row of holes extend along the longitudinal axis of the volume filling device.

Method for placing a reflux tmatment device on the inside of the stomach wall

[00459] In the following a method and an instrument for placing arflux tmatment device on the inside of the stomach wall will be described.

[00460] The invagination instrument described in Hg. 52a-1 generally designated 630, comprises an elongated tube member 632 similar to the elongated member 607 described above with refernce to Hgs. 48a-i. hus, it can be connected to a control unit 606, see Hg. 48a.The invagination instrument 630 further comprises a perforated suction portion 634, which preferably is elongated. The suction portion 634 exhibits a plumlity of small holes 636, into which air will be sucked by providing suction in the tube member 632. his suction effect will be used to cmate a "pocket" or "pouch" in a part of a stomach wall, generally designated 12a.

[00461] In other words, when the tip of the suction portion 634 is pressed against the stomach wall 12a, see Hg. 52a, a small ecess will be formed therin. When the suction portion 634 is further passed against the stomach wall 12a, see Hg. 52b, a largerrecess will be formed. The part of the stomach wall 12a that forms the recess will, due to the suction effect adhere to the suction portion 634 of the invagination instrument 630. As the suction portion 634 is further passed into the stomach wall 1 2 v see.Fig. 52c, a deeper recess will be formed until the entire suction portion 634 is embedded in the recess, see Fig. 18d.

[00462] The rim of the recess will at this stage be fixated by means of fixation elements 638 and the suction portion be removed from the instrument, see Fig. 52e. A compressed elastic reflux treatment device 10 will subsequently be inserted into the recess, see Fig. 52f, for example in the way described above with reference to Fig. 47d. This compressed reflux treatment device is then expanded to its final shape, see Fig. 52g, where after the pouch is sealed by suturing or stapling by means of the fixations elements, see Fig. 52h.

[00463] All the alternatives described above with reference to Figs. 1-51 are also applicable to the embodiment described with reference to Figs. 52a-h, i.e., to the embodiment where the reflux treatment device is invaginated on the inside of the stomach wall.

[00464] Figs 53 a-c show an instrument for creating an invagination of the wall of the stomach that can either be placed on the outside of the wall of the stomach or on the inside of the wall of the stomach depending if the reflux treatment device is place on the inside or the outside of the wall. The instrument uses vacuum to such a portion of the wall of the stomach into the cup of the instrument.

[00465] It has been described how the reflux treatment device 10 is invaginated in the stomach wall by means of a gastroscopic instrument. The gastroscopic instrument can be used for either placing the reflux treatment device on the outside of the wall of the stomach as shown in figure 1A or on the inside of the stomach as shown in figure 2A. In the latter case, the instruments will be used to make an incision in the wall of the stomach from the inside of the stomach.

[00466] It will be appreciated that abdominal operation methods can be used as well. Such methods will now be described in with reference to Figs. 54

RECTIFIED SHEET (RULE 91)

55.In figum 54 itis shown how the stomach is accessed by creating an incision 380 n the abdomen of the patient In figum 55 it is shown how an instrument381 is inserted into the abdomen of the patient Any of the instruments and methods described can be selected an adapted for this purpose. hus, for example, the rflux tmatment device can be placed on the outside of the stomach as shown in figure 1A or on the inside as shown in figum 2A. In the later case an incision is made in the wall of the stomach

Stimulation- detailed description

[00467] FIGURE 56 schematically shows an embodiment of the heartburn and rflux disease apparatus of the invention having some parts implanted in a patient and other parts located outside the patient s body. hus, inFIGURE 56 all parts placed to the right of the patient s skin 2x am implanted and all parts placed to the left of the skin 2x ar located outside the patient s body. The apparatus of FIGURE 56 comprises an implanted electric stimulation device 4, which engages the patient s cardia sphincter to prvide electric connection therto. An implanted control unit 6x controls the stimulation device 4x via a control line 8x. An extemal control unit 10x includes an extemal source of energy and a wireless rmote control transmitting a control signal generated by the extemal soure of energy. The control signal is received by a signalreceiver incorporated in the implanted control unit 6x, whereby the control unit 6x controls the implanted stimulation device 4x in response to the control signal. The implanted control unit 6x also uses electric energy drawn fim the control signal for powering the stimulation device 4x via a power supply line 12x.

[00468] FIGURE 57 shows an embo diment of the invention identical to that of FIGURE 56, except that an implanted intemal electric source of energy in the form of a battery 42x is substituted for the extemal souce of energy. hus, an extemal control unit 40x without any source of energy is used in this embodiment In response to a contl signal fim the extemal conrl unit 40x the implanted control unit 6x powers the simulation device 4x with energy fim the battery 42x.

[00469]

[00470] FIGURE 58 shows an embodiment of the invention comprising the stimulation device 4x, the extemal control unit 10x, and an implanted source of energy 236x and an implanted switch 238x. The switch 238x is operated by wireless energy released fim the extemal source of energy of the extemal control unit 6x to switch between an off mode, in which the implanted source of energy 236x is not in use, and an on mode, in which the implanted source of energy 236x supplies energy for the power of the simulation device 4x.

[00471] FIGURE 59 shows an embodiment of the invention identical to that of FIGURE 58, except that also the contml unit 6x is implanted, in order to receive a control signal from the wireless rmote conrl of the extemal conrl unit 10x. The switch 238x is operated by the wireless energy fm the extemal source of energy x to switch between an off mode, in which the implanted source of energy 236x and the wireless rmote control of the extemal control unit 10x am notin use, i.e. the control unit 6x is not capable ofreceiving the control signal, and a standby mode, in which the wireless rmote control is permitted to control the intemal soure of energy 236x, via the implanted control unit6x, to supply energy for the power of the stimulation device 4x.

[00472] FIGURE 60 shows an embodiment of the invention identical to that of FIGURE 59, except that an energy transforming device for transforming the wireless energy into storable energy is incorporated in the implanted control unit 6x and thatthe implanted source of energy 236x is of a type thatis capable of storing the storable energy. In this case, in response to a control signal fim the extemal conrl unit 10x, the implanted control unit 6 contmls the switch 238x to switch fim an off mode, in which the implanted source of energy 236x is not in use, to anon mode, in which the source of energy 36x supplies energy for the power of the stimulation device 59x.

[00473] FIGURE 61 shows an embodiment of the invention identical to that of FIGURE 60, except that an energy storage device 240x also is implanted in the patient for storing the storable energy transformied fim the wireless energy by the transforming device of the conrlunit 6x. In this case, the implanted conrl unit 6x conrls the energy storage device 240 to operate the switch 238x to switch between an off mode, in which the implanted source of energy 236x is notin use, and an on mode, in which the implanted soure of energy 236x supplies energy for the power of the simulation device 4x.

[00474] FIGURE 62 schematically shows conceivable combinations of implanted components of the apparatus for achieving various communication possibilities. Basically, there ae the implanted stimulation device 4x, the implanted conrl unit 6x and the extemal control unit 10x including the extemal source of energy and the wireless rmote contrl. As almady described above the emote conrl transmits a control signal generated by the extemal source of energy, and the contml signal is received by a signalreceiver incorporated in the implanted control unit 6x, whereby the control unit 6x controls the implanted simulation device 4x in response to the control signal.

[00475] A sensor 54x may be implanted in the patient for sensing a physical parameter of the patient such as the prssum in the esophagus. 'ihe control unit 6x, or alternatively the extemal control unit 1Ox, may control the stimulation device 4x in response to signals fim the sensor 54x. A transceiver may be combined with the sensor 54x for sending information on the sensed physical parameter to the extemal conrl unit 10x. The wireless rmote conrl of the extemal control unit 10x may comprise a signal transmitter or transceiver and the implanted control unit 6x may comprise a signal receiver or transceiver. Alternatively, the wireless rmote control of the extemal control unit 10x may comprise a signal receiver or transceiver and the implanted control unit 6x may comprise a signal transmitter or transceiver. The above transceives, transmittes and received may be used for sending information or data slated to the simulation device fominside the paient's body to the outside thereof. Fbr example, the battery 32x may be equipped with a transceiver for sending information on the charge condition of the battery.

[00476] Those skilled in the ait will realize that the above various embodiments according to FIGURE 56-61 could be combined in many different ways.

[00477] FIGURE 63 illustrates how any of the above-described embodiments of the heartburn and rflux disease treatment apparatus of the invention may be implanted in a patient Thus, an assembly of the apparatus implanted in the patient comprises a stimulation device in the form of a band 56x, which is wrapped around the cardia 58x. The band 58x is provided with conductOn that electrically contact the cardia sphincter and an operation device 60x for operating the simulation device 56x. An implanted control unit 60x is provided for controlling the supply of electricity to the band 56x. There is an implanted energy transforming device 62x for transforming wireless energy into electric energy. The transforming device 62x also includes a signal receiver. An extemal control unit 64x includes a signal transmitter for transmitting a control signal to the signal receiver of the implanted transforming device 62x. The transforming device 62x is capable of transforming signal energy fim the control signal into electric energy for powering the stimulation device 60x and for energizing other energy consuming implanted components of the apparatus.

[00478] FIGURE 64 shows the basic parts of a wireless rmote control of the apparatus of the invention including an implanted electric stimulation device 4x. In this case, the emote control is based on the transmission of electromagnetic wave signals, often of high frequencies in the order of 100 kHz - 1 gHz, through the skin 130x of the patient In FIGURE 64, all parts placed to the left of the skin 130x ar located outside the patient's body and all parts placed to the right of the skin 130x am implanted. Any suitable remote control system may be used.

[00479] An extemal signal transmitting antenna 132x is to be positioned close to a signal receiving antenna 134x implanted close to the skin 130x. As an alternative, the receiving antenna 134x may be placed for example inside the abdomen of the patient The receiving antenna 134x comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter, wound with a very thin wim and tuned with a capacitor to a specific high fmquency. A small coil is chosen if itis to be implanted under the skin of the patientand a large coil is chosen if itis

to be implanted in the abdomen of the patient 'Ihe transmitting antenna 132x comprises a coil having about the same size as the coil of thereceiving antenna 134x butwound with a thick wire thatcan handle the larger currents that's necessary. The coil of the transmitting antenna 132x is tuned to the same specific high fmquency as the coil of the receiving antenna 134x.

[00480] An extemal control unit 136x comprises a micrprocessor, a high fmrquency electromagnetic wave signal generator and a power amplifier. The microprocessor of the control unit 136x is adapted to switch the generator on/ off and to modulate signals generated by the generator to send digital information via the power amplifier and the antennas 132x,134x to an implanted control unit 138x. ' avoid that accidental random high frequency fields trigger control commands, digital signal codes am used. A conventional keypad placed on the extemal contml unit 136x is connected to the microprocessor therof. The keypad is used to order the microprocessor to send digital signals to either power or not power the stimulation device. The microprocessor starts a command by applying a high fmquency signal on the antenna 132x. After a short time, when the signal has energised the implanted parts of the control system, commands am sent to power the stimulation device. The commands am sent as digital packets in the form illustrated below.

Startpattem, 8 bits Command, 8 Count, 8 bits Checksum, 8 bits bits

[00481] The commands may be sent continuously during a rather long time period. When a new power or not power step is desired the Count byte is increased by one to allow the implanted control unit 138x to decode and understand that another step is demanded by the extemal control unit 136x. If any part of the digital packet is erroneous, its content is simply ignored.

[00482] Thmugh a line 140x, an implanted energizer unit 126x draws energy fim the high fmquency electromagnetic wave signals received by the receiving antenna 134x. The energizer unit 126 stores the energy in a power supply, such as a large capacitor, powers the control unit 138x and powers the electric stimulation device 4x via a line 142x.

[00483] The controlunit138x comprises a demodulator and a microprocessor. The demodulator demodulates digital signals sentfrom the extemal control unit 136x. The microprocessor of the control unit 138x receives the digital packet decodes it and, provided thatthe power supply of the energizer unit 126x has sufficient energy stord, powers the stimulation device 4x via a line 144x.

[00484] Altemaively, the energy stord in the power supply of the energizer unitmay only be used forpowering a switch, and the energy forpowering the stimulation device 4x may be obtained fm another implanted power source of relatively high capacity, for example a battery. In this case the switch is adapted to connect said battery to the control unit 138x in an on mode when the switch is powered by the power supply and to keep the battery disconnected fim the control unit in a standby mode when the switch is not powered.

Stoetching - detailed description

[00485] Here follows detailed description of two embodiments of the invention where tmatment of flux is combined with treatment of obesity. rst, embodiments showing a stitching device am shown

[00486] Invaginated in the stomach wall is to be understood as an object being placed inside of a cavity made of stomach wall material. The invagination enables stomach to stomach suurs or staples which enables the object of be enclosed by means of the human tissue healing.

[00487] Hg. 65 shows a fist embodiment of an obesity tmatment apparatus. The apparatus comprises a stitching device 10y implanted in a human patient In Hg. 65 the stitching device 10y is invaginated in the wall 12y of the patient's stomach 12y and the body of the stitching device 10y is shaped to rest against the wall 12y of the stomach 12y and further has an outer surface suitable to mest against this wall 12y. his means that the stitching device 1Oy preferably has an essentially round shape to not damage the stomach wall. However, the stomach wall 12y is strong so many different shapes and forms may be used.

[00488] The stitching device 1y can be fixed to the wall 12ay of the stomach 12y in a number of differmntways. In the embodiment shown in Hg. 65, the stretching device 10y is invaginated in the stomach wall 12ay. After in-vagination, a number of stomach-o-stomach suturs or staples 14y am applied to keep the in-vagination in the short term. 'Ihis allows growth of human tissue, keeping the in-vagination in the long term.

[00489] By enlarging the size of the stitching device, the stomach wall 12y surrounding the stitching device 10y is stitched since the cirumference of the stretching device 10y is increased. By this strtching, rceptorsin the stomach wall indicate that the stomach is full, thereby crating a feeling of satiety to the patient Corrspondingly, when the stitching device 10y is contracted, the rceptors indicate thatthe stomach is notfull, thereby rtuming the feeling of hunger.

[00490] The expansion and contraction of the stretching device 1Oy can be performed under direct control of the patient Altematively, the expansion and contraction can be performed according to a p-pgrammed schedule.

[00491] Retuming toIug. 65, this figum also shows a fluid operation device, i.e., a hydraulic or pneumatic operation device suited for operating the stitching device, which in the following will be described in detail.

[00492] The stitching device 1Oy forms a fluid chamber, in which fluid is allowed to flow. The stitching device 1Oy thus forms an expandable chamber that can change the volume it occupies in the stomach wall, thereby forming a hydraulically or pneumatically rgulated stitching device 1Oy.

[00493] A rgulation reservoir 16y for fluids is connected to the stitching device 10y by means of a conduit 18y in the form of a tube. The stitching device y is thereby adapted to be gulated, preferably non-invasively, by moving liquid or air fim the rgulation rservoir 16y to the chamber formed by the stitching device.

[00494] The rgulation rservoir 16y can be rgulated in several ways. In the embodiment shown in Ig. 65, the rgulation rservoir 16y isrgulated by manually pressing the rgulation reservoir 16y. In other words, the rgulation reservoir 16y is rgulated by moving a wall of the reservoir. It is then prfered that the rgulation reservoir 16y is placed subcutaneously and non-invasive rgulation is therby achieved.

[00495] When the rgulation reservoir 16y is pressed, the volume thermof decreases and hydraulic fluid is moved fim the reservoir to the chamber formed by the stitching device 1Oy via the conduit 18, enlarging or expanding the stitching device 1Oy. Fbr filling and calibrating the fluid level of the apparatus an injection 100ly portis furthermore provided. The injection portprmferably comprises self sealing membrane, such as a silicone membrane.

[00496] It will be appreciated thatinstead of hydraulic operation, pneumatic operation can be used, wherein air instead of hydraulic fluid is moved between the reservoir 16y and the chamber formed by the stitching device 1Oy. leferable the reservoir has a locking position to keep itin the desired position Ifthe patient compresses the reservoir 16y it prferably stays compressed andreleases after pressing again.

[00497] Any kind of hydraulic solution may be used for the stretching device. he hydraulic solution may be driven by both mechanically and be powered with any motor or pump as well as manually.

[00498] Ig.65 further shows a reversed servo system which comprises a regulation reservoir 16y and a servo reservoir 90y. The servo reservoir 90y hydraulically controls a stitching device 10y via a conduit 18y. The verse servo function is described in greater detail in figs. 97-100

[00499] Ig. 66a shows the apparatus according to another embodimentin which a motor 40y is adapted to move a wall of thergulationrservoir 16y. The powered rgulation reservoir 16y is then preferably placed in the abdomen of the patient In this embodiment, a wireless external rmote control unit 34by,cy and an external energy transmission device 34ay can be provided to perform non-invasive regulation of the motor via an energy transforming device 30y, which is adapted to supply an energy consuming operation device, in the present example the motor y, with energy.

[00500] The emote control may comprise a wireless energy transmitter, 34ay which also can act as argulation device for non-invasivelyrgulating the stretching device. When the rgulation is performed by means of a mmote control 34y an intemal power source 70y for powering the rgulating device is provided. The intemal energy source 70y can for example be a chargeable implanted battery or a capacitoror a device for receiving wireless energy transmitted fim outside the body of the patient Different ways of regulating the stitching device 1Oy will be described below with refernce to Figs. 77-100.

[00501] The apparatus as shown in fig. 66a further comprises a sensor 201y sensing a parameter of the patient or the apparatus preferably connected to the food intake of the patient The sensor is connected to a control assembly 42y by means of a sensor signal transferring member 202y. The sensor can be used to regulate said apparatus in a completely automatic way, i.e. the apparatus responds to a sensor signal connected to the food intake of the patient, therby affecting the control assembly to operate the stitching device 10y to strtch the stomach wall 12y and therby crating a feeling of satiety in the patient The sensor could be adapted to measum the food intake of the patientthrough any of temperatume, blood prssue, blood flow, heartbeats, breaking and prssum and can be placed in the stomach 12y, esophagus 203y or in connection with the cardia 204y.

According to one embodiment said sensor is a strain gauge measuring contraction and/ or mlaxation of the cardia 204y.

[00502] The apparatus as shown in fig. 66a further comprises a second conduit 222y for backflow of hydraulic fluid. The backflow is adapted to cmate the desired feeling of satiety for a prdetermined time wherafter the hydraulic fluid has flowed back in a quantity large enough for the stitching device not to stitch the stomach wall anymore and therby the feeling of hunger rtums to the patient A suitable time for the process is between 1 and 6 hours. According to other embodiments the backflow takes place in the main conduit 18y by means of a valve system connected to said conduit 18y.

[00503] Fbr filling and calibrating the fluid level of the apparatus an injection 100ly portis futheior provided. The injection port 100ly preferably comprises self sealing membrane, such as a silicone membrane.

[00504] Hg. 66b shows the apparatus according to the embodiment of fig. 66a, in a second state in which the stretching device 10y is expanded and thereby stitches the stomach wall 12y.

[00505] Hg. 67a shows an embodiment wherin two stitching devices "y ar provided. Both stitching devices 10'"y work according to the principles described above with reference to Hg. 65. They can be adapted to postoperatively and non-invasively be rgulated and adapted to fom time to time rgulate different stitching devices to at a fist time stretch a fist part of the stomach wall and at a second time stmtch a second part of the stomach wall.

[00506] Such a stitching device 1Oy maybe used for keeping electronics and/ or an energy source and/ or hydraulic fluid. Hydraulic fluid from that device may be distributed to several smaller stitching device amas to vary the stitching aa from time to time avoiding any possible mor permanent stitching effect of the stomach wall. Even mechanically several stretching amas may be used. The embodimentaccording to fig. 67a further comprises a hydraulic valve shifng device 54y, implanted in the patient for shifting between operating the first and the second stitching device 10'y. The alternating crates a mom sustainable device since the rceptors in the stomach wall is stimulated gets a longer time ofrecovery between the streches.

[00507] In fig. 67a the systems a manual system controlled by the patient as described before with refernce to fig. 65, whereas in fig. 67b the systems energized using wireless energy as described before with refernce to fig. 66a.

[00508] Hg. 68a-e shows different embodiments of the stitching device y adapted to be implanted in a patient The stitching device 10y comprises a surface adapted to be in contact with the stomach wall 12y when the device is invaginated in the stomach wall. Hg. 68b shows an embodiment of the stitching device in which the stitching device comprises a fixating member 206y for suturing or stapling the stitching device to the stomach wall. The fixating member206y could comprise holes for receiving said suurs or staples 14y, or the fixation device 206y could be penetraable such that the suurs or staples can penetrate the stomach wall and the fixation device 206y. 68c shows the stitching device 10y according to an embodimentin which the stretching device lOycomprises an inlet member 207y for filling said device with a fluid. Said inletmember is preferably connected to a hydraulic conduit 18y adapted to be invaginated in the stomach wall 12y. Hg. 68d shows the stretching device 10y according to an embodimentin which the stitching device 10y comprises a holding member 208 adapted to connect to an insertion device when said stitching device 1Oy is inserted into an invaginated pouch of the stomach wall 12y. Hg. 68e shows the stitching device y according to an embodimentin which the stitching device has a slightly oval or egg-shaped shape. Hg. 68e furhemior shows the hydraulic conduit18 attached to said stitching device 10y. Hg. 68f shows the stitching device 10y according to an embodimentin which the stitching device is inflatable by a fluid transported though the conduit 18y. According to one embodiment shown in fig. 68f the conduit comprises two sections 18ay, 18by wheein the fist section 18ay is used to pull the stitching device 10y into place, and to fill the device 10y with a suitable fluid, whereas the second section 18by is used for the operation of said device 1Oy. Hg. 68g shows the stitching device 10y according to the embodimentof fig. 68f in a deflated state. The stitching device 10y is inserted though a hole in the stomach wall 12y in its deflated state wherafter the device 10y is filled with a suitable fluid for operation Hg. 68h shows the stitching device 10y according to an embodimentin which the stitching device 10y comprises two movable wall portion 223ay, 223by, which am moveable by means of a bellows structure 209y made of a flexible material. Hg. 68i shows the stitching device according to an embodiment where the stitching device is expandable by means of four expandable sections 210y symmetrically placed on four places along the surface of the stitching device, as shown in the section image of fig. 68i. The expandable sections 210y ar made of a flexible material for allowing said sections 210y to expand when said stitching device 10y is filled with a hydraulic fluid.

Surface structum of implants

[00509] The general structum of any implanted device of the invention will now be described with refernce to figum 69 a-k The pesentinvention concerns an implant adapted to po st-operatively be adjustable and comprising at least one expandable section, wherein the implantis adapted to be adjustable between a fist collapsed state and a second expanded state. In the fist collapsed state the expandable section is collapsed, and in the second expanded state, the expandable section is expanded. The outer surface of said expandable section does at least partly comprise a surface structum having elevated amas alternating with lowered ameas. The expandable section is adapted to have, in at least one of said fist collapsed and second expanded states a fist distance between adjacent elevated ameas sufficiently extended to pmvent growth of fibroic issue fm dimectly interconnecting adjacent elevated amas to an extent that compromises the adjustability between a fist collapsed and a second expanded state of said implant The expandable section further comprising connecting amas between adjacent elevated and lowered amas, further adapted to have, in atleast one of said fist collapsed and second expanded states, a second distance between adjacent connecting amas sufficiently extended to pmvent growth of fibrotic issue fim diecty inteconnecting adjacent connecting amas to an extentthat compromises the adjustability between a fist collapsed and a second expanded state of said implant

[00510] According to one embodimentthe expandable section is hollow or comprises a hollow body.

[00511] According to another embodiment the implantis substantially completely hollow or comprises a hollow body extending along substantially the complete length and/ or complete volume of said implant

[00512] Fbrotic tissue can often have an extension or thickness of about 0,5 mm to about 1,5 mm and hence the distances between levant surfaces of the elements of the surface structum am suitably grater than about 3 mm, hence greater than about 2 x 1,5mm. But depending on the circumstances also distances grater than about1,0 mmto about3 mmmay be sufficient In cases where the fibrotic tissue can be expected to have an extension or thickness grater than about 1.5 mm the distances between levant surfaces of the elements of the surface structum am adapted in a suitable manner.

[00513] The surface structum may comprise elevated and lowered amas and it may be suitable that also a distance between the different planes of the elevated and lowered aas is bigger than a certain threshold to facilitate the collapsible and/ or expandable functionality of the implant If said distance is too small, the collapsible and/ or expandable functionality of the implant may be limited. A suitable interval for said distance is around 0,5 to 10 mm, mor suitable around2-8mmandmostsuiableaund 3-7 mmThe surface structum may comprise different geometrical elements or shapes and any combination of such elements or shapes as long as the above mentioned conditions for the distances can be met The surface structum may e.g. comprise ridges and grooves of different shapes. 'Ihe ridges and grooves may each have a cross-section thatis e.g. wedge shaped, polygonal, squam-fornied, pyramidal-shaped, truncated pyramidal-shaped or. Rher may the ridges and grooves have cross-sections of different shapes. The surface structum may as well in general comprise a bellows-shaped structum or a surface structum where geometrical objects of the same or differentkind(s) am placed on a surface. The geometrical objects may be practically randomly placed on the surface or according to some scheme.

[00514] One type of implants where this type of surface structum may be suitable, is implants where the implant should have the ability to change shape and/ or size substantially. Hence, this is a case where the presence of fibrotic tissue substantially could hinder or impede the function of the implant Butthe surface structum may be used by any implant where the characteristics of the surface structum would be advantageous for the implant

[00515] A fist distance 708a between two elevated amas 701, see fig. 69a, is long enough so as to pventgrowth of fibrotic tissue directly connecting two adjacent elevated amas 707. Ihat is, it may be possible that fibrotic tissue grows on the surface of the elevated and lowered amas 701, 702 and the connecting amas 704. However, thanks to the extension of the first distance 708a, fibrotic tissue is pmvented fim growing dimcty fim one elevated aea 701 to another adjacent elevated aea 701.

[00516] With the expression "growing directly fim one elevated ama 701 to another elevated aea 701" itis e.g. meant that fibroic issue grows fim one elevated aea 701 to another while not or only to a small extentgrowing on a connecting aea 704. As indicated at704a in fig. 69i, the first distance 708a may be measured within an interval 704a fim the level of an elevated aea 701. The expression "growing diecly fim one elevated aea 701 to another elevated ama 701" also includes the situation thatfibroic issue grows on adjacent amas, e.g. two adjacent connecting areas 704, with such a thickness that the fibroic issue fim each adjacent ama meet and bridge the distance or space between two elevated amas 701. In such a situation the space between two elevated amas 701 may be partly or completely filled with fibrotic tissue.

[00517] It maybe advantageous that also a second distance 708b cornsponding to the extension of a lowered aea 702 has an extension grat enough so as to pmvent fibrotic tissue fm growing dimctly fim one connecting ama 704 to another connecting aa 704. With the expression "growing dimcty fiom one connecting ama 704 to another connecting ama 704" it is meant that fibrotic tissue grows fim one connecting ama 704 to another while not or only to a small extentgrowing on a lowered aea 702.

[00518] In fig. 69i a surface structum comprising elevated and lowered amas has been shown, but apart fim elevated and lowered amas also many other geometrical structurs may be used where it is possible to fulfill the above mentioned pmvention of growth of fibrotic tissue. In particular, the above mentioned prvention of growth of fibrotic tissue between elevated amas and between connecting amas.

[00519] Some examples of such other geometrical structures a shown in figs. 69i-k Ina surface structum comprising ridges and grooves, the ridges and grooves may also have different sections, some examples am shown in figs. 69b-69e.

[00520] Referring mainly to Figs. 69a and b some expressions and aspects will now be explained. In this application the concept of a first distance 708a, 718a between adjacent elevated amas 701, 710 is used. With such a first distance 708a, 718a itis meanta distance that's measured substantially fim the edge 706, 714 of one elevated aea 701, 710 to the edge 706, 714 of an adjacent elevated aea 701, 710. Measued substantially fiomthe edge means that the measumment maybe done within firstinterval 704a fimthe level of an elevated aea 701, 710, the firstinterval 704a extending fiomthe level of an elevated aea 701, 710 towards the level of an adjacentloweed aea 702, 712.

[00521] In this application also the concept of a second distance 708b, 718b between adjacent connecting amas 704, 716 is used. With sucha second distance 708b, 718b it is meant a distance that is measured substantially fim the connection point between a connecting ama 704, 716 and a lowered ama 702, 712 to another connection pointinvolving an adjacent connecting ama 704, 716. Measued substantially fom the connection point means that the measurement may be done within a second interval 704b fom the level of a lowered aea 702, 712, the second interval 704b extending fOm the level of a lowered aa 702, towards the level of an adjacent elevated aea 701, 710.

[00522] With elevated and lowered aas it is meant amas that lie in differentplanes 703, 705, 720, 722 where the planes am separated by a distance 707, 724, 728.The planes may be parallel or substantially parallel but may also be non-parallel. Ifthe planes am parallel, defining a distance between them is trivial. If the planes am non-parallel (as in fig. 2a) a distance between the planes may be defined by a normal 724, 728 to one of the planes 720, 722 where the normal extend to a pointon an ama in another plane 722, 726 and the distance between the planes is equal to the extension of the normal 724, 728. As seen in fig. 2a the normal 724, 728 extends fim a plane 720, 722 to a point which is approximately equally distant fiom the edges of an ama. There a two possible ways to define the normal or distance between the planes. 'Lking normal 728 as example, one may define the normal as in 728a or in 728b. Itmay be suitable to define the distance between two planes as the extension of the longest normal, the distance between the planes 720 and 722 would then be equal to the extension of normal 728a. This definition will be used herafter.

[00523] The elevated and lowered amas may have different shapes, they may be plane or substantially plane but they may also have some kind of curved shape.

[00524] The elevated amas 701, 710 connectto adjacentlowered amas 702, 712 by means of connecting areas 704, 716. The connection between elevated/ lowered amas and connecting amas 704, 716 may comprise a radius of different sizes, bigger or smaller radii. When the radius is very small there will substantially be an edge 706, 714 connecting the amas.

[00525] The expression "expandable section' implies that said section also is collapsible.

[00526] Suitably the implantable device 10 atleast partly comprises materials which have a high degre of biocompatibility, such materials may be called physiologically inert, biologically inert or biocompatible.

[00527] Refening in particular to figs.69a-b, in the surface structure 700 there may advantageously be a specified fist distance 708a, 718a between adjacent elevated amas 701, 710. The distance between adjacent elevated amas 701, 710 is chosen so thatfibtic tissue cannotbridge the firstdistance 708a, 718a between adjacent elevated amas 701, 710. Hence, the fist distance 708a,

718a between adjacent elevated amas 701, 710 is advantageously big enough to pmvent the formation of fibrotic tissue that bridges adjacent elevated amas 701, 710.

[00528] As mentioned before, there may advantageously be a specified second distance 708b, 718b between adjacent connecting amas 704, 716. The second distance 708b, 718b between adjacent connecting amas 704, 716 is chosen so thatfibrotic tissue cannotbridge the second distance 708b, 718b between adjacent connecting amas 704, 716. Hence, the second distance 708b, 718b between adjacent connecting amas 704, 716 is advantageously big enough to pmvent the formation of fibrotic tissue that bridges adjacent connecting amas 704,716.

[00529] It may also be advantageous that a third distance 707, 724, 728a between the differntplanes 703, 705, 720, 722, 726 of the elevated and lowered amas is bigger than a certain threshold to facilitate the collapsible and/ or expandable functionality of the implant Ifthe third distance 707, 724, 728a is too small the collapsible and/ or expandable functionality of the implant may be limited. A suitable interval for the thirddistance 707, 724, 728a is 0,5 to mm, mor suitable 2-8 mm and most suitable 3-7 mm . Also regarding the aspect that the fibrotic tissue should not impede the collapsible/ expandable functionality of the implantable device itis advantageous thatthe distance 707, 724, 728a is nottoo small, butsuitably in the interval/ s as mentioned pmviously.

[00530] The surface structum 700 may include objects or elements of different geometrical shapes, for example ridges of different shapes, embossments of different shapes and other objects which enable a surface structum as described herein The ama of the elevated amas 701, 710 may be very small while still rsulting in a surface structum that has the desired functionality. The ama of the elevated amas 701, 710 may even be almostzero, as exemplified in fig. 2d.

Whemeas figs. 1 and 2a-2d show crss sections of examples of surface structurs 700, figs. 69i-k show examples of different surface structurs 700 in perspective. The objects or elements in the surface structum 700 may be placed in rws, orderd in some other way, or may be mom or less randomly distributed over the surface of the implant Differnt types of objects may also be used together in the surface structum 700, e.g. a combination of pyramid shaped and cone shaped objects together with ridges o f some shape.

[00531] In figs. 69f-h an embodiment of an implant 10 is shown where a surface structum 700 is used, the implant 10 is not shown in full. Ig. 69f shows a longitudinal section of the implant 10 where 740 denotes the surface structum on the upper side of the implant 10 and 742 denotes the surface structum on the underside of the implant 10. As shown in fig. 69f the surface structum 742 on the underside may have a grater extension than the surface structum 740 on the upper side of the penile pro sthesis. his gives the implant 10 an up-bent po sition when the implant 10 is expanded. The surface structurs 140 and 142 am one example of a bending portion Ig. 69g shows a crss section of the implant10 where the implant 10 includes a waist portion 744, where the waist portion comprises waist surface structurs 746 and 748. The waist portion with the waist surface structurs 746 and 748 make the implant 10 expandable also in the radial direction The implant 10 may also have a crss section as shown in fig. 69g comprising a waistportion 744 having four waist surface structurs 750, 752, 754, 756 further facilitating the ability of the implant 10 to be expandable also in the radial direction 'he crss sections in figs. 69g and h are taken along the line Al A2 in fig. 69f.

Rather embodiments comparing a stoetching device.

[00532] Rulher embodiments of the inventions that disclose the treatment of obesity by stitching the stomach will now be described.

[00533] Hg. 70a illustrates a stitching device 1 0 y provided with an inlet port 18by. 'The stitching device 10 is invaginated in the stomach wall 12y and the inletport 18by is available for connection to a tube or the like fm the abdominal ama of the patient The tube or conduit18y can preferably be connected to the control unit 42y or an injection port 100ly.

[00534] Hg. 70b illustrates an invaginated stitching device 1Oy wherein, instead of an inlet port, a conduit 18y or electrical lead extends into the abdominal ama of the patient

[00535] Hg. 70c shows a section of the stitching device 10y and part of the stomach in which the stitching device 10 is invaginated. The conduit 18y or electric lead is invaginated in the stomach wall 12y by means of stomach to stomach suturs or staples 14y which crates an entirely sealed pouch of stomach wall tissue in which the stitching device 10y is placed. The conduit 18y or electric lead is therby tunneled in the stomach wall 12y between the inletport 18byand the volume filling device 10y.

[00536] Ithas been shown that the shape of the stitching device 10y can take many different forms. It will be appreciated that also the material of the stretching device 10y can vary. Itis prfered that the stitching device 10y is provided with a coating, such as a Paylene, polytetrafluoroethylene (P1E),or polyurethane coating, or a combination of such coatings, i.e., amulti-layer coating. Ihis coating or multi-layer coating improves the properties of the stitching device, such as its rsistance to wear.

[00537] In another embo diment shown in Hg. 71, the stitching device 110y works according to a different principle fom that described above with reference to Hgs. 65-70. The stitching device 110y here comprises a fistfixation portion 110 ay adapted to have a fist fixation at a fist po sition on the stomach wall

12y and a second fixation portion110by adapted to have a second fixation at a second position on the stomach wall 1 2 yThese fixation portions 110ay,by, which preferably have an essentially round shape and preferably am adapted to be invaginated in the stomach wall 12y, am attached to the distal end of arespective leg 21ly, which in turn ar attached at theirrspective proximal end to an operation device, such as a motor 40y. According to the embodiment shown in fig. 71 the motor is a hydraulic motor, comprising a hydraulic piston, which is connected to a manual operation device described pmviously with refernce to fig. 65. The hydraulic piston affects the legs through their connection with a joint 212y placed in the extomity of the leg. The stitching device 110y is enclosed in a housing 214y protecting the device fim the in growth of fibrotic tissue which potentially could damage the function of said device 110y. However itis equally conceivable that the motor is another hydraulic motor, a pneumatic motor or an electrical motor.

[00538] The stitching device 11Oy is adapted to increase the distance between the fist position and the second position on the stomach wall 12y, therby stretching the stomach wall 12y. The first and/ or second fixation portions 110ay, 110by am adapted to atleastpartly be invaginated in the stomach wall 12y with stomach-o-stomach suturs or staples 14y holding the fixation portions 110 ay, by in place in suspension in mlation to the stomach wall 12y.

[00539] Of course the fist and second positions may be sutued or fixated to the stomach wall in many possible ways and the invention cove all possibilities to distend the stomach wall by moving two portions of the stomach wall away fim each other and therby firstfixating the device to atleasttwo positions on the stomach wall. However, the soft suspended connection to the stomach wall 12y where fibrotic stomach-o-stomach tissue helps to give a long term stable position is to prefer.

[00540] Of course just expanding an in-vaginated part of the stomach also stitches away the stomach wall 12y which also may be achieved both mechanically, hydraulically, pneumatically and both being powered with a motor pump or by manual foree.

[00541] Any kind of mechanical construction may be used and the mechanical embodiment disclosed is one example. Any mechanical construction driven by mechanically or hydraulically or any pneumatic construction may be used. Any motor or any pump or moving material changing form when powered may be used to achieve the simple goal of stitching a part of the stomach wall by moving at least two portions of the stomach wall away fiom each other.

[00542] Ig. 72 shows the stitching device 11Oy according to an embodiment in which the stitching device is controlled fim an implantable control assembly 42y to which sensor input as described earlier, inreceived. The stitching device is then rgulated through the conduit 18y using a pump 44y, connected to at least one fluid reservoir 16y, 46y, and powered fm a energy transforming member 30y connected to an receiver of wireless energy 205y, placed under the skin 36y, or an implantable energy source 70y, such as arechargeable battery.

[00543] In a variant shown in Ig. 73a, the first and/ or second fixation portions 210ay, 210by, respectively, exhibit a structum adapted to be in contact with the stomach wall 12y to promote growth in of human tissue to secure the long term placement of the stitching device 110y attached to the stomach wall 12y. Ihis structum preferably comprises a net like structm 213y. The fixation portions 210ay, 210by may be adapted to keep the stitching device 110y in place by sutures or staples between the fixation portion and the stomach wall 12y to secume the shortterm placement of the stitching device 110y. In tuns of mechanical operation the stitching device 11Oy according to the embodiment shown in fig. 73a functions in accordance with the device described with refernce to fig. 71.

Hg. 9by shows a fixation device 23y comprising a netlike structum adapted to propagate the grwth-in of fibrotic tissue to fixate the two fixating portions to the stomach wall 12y.

[00544] Hg. 73c shows the stitching device according to the embodiment of fig. 73a in a second state, in which the two fixating portions have been separated frm each other and the stomach 12y has been stoetched.

[00545] Hg. 74a shows the stretching device according to an embodiment in which the stitching device is an electrical mechanical stitching device connected to a control assembly 42y though a power supply line 32'y. The power supply line 32y is connected to a power transforming device 30y in contactwith a receiver of wireless energy 205y, such as a coil, which receives energy frm a transmitter of wireless energy 34ay. The control assembly may furthermore comprise a battery 70y for storing energyreceived frm the wireless energy transmission device 34ay. The control assembly receives input frm a sensor 201y, which according to this embodiment is a strain gauge measuring the contraction and/ or mlaxation of the cardia 204y.

[00546] Hg. 74b shows the stitching device 10y in further detail. 'Ihe stretching device 10y comprises a housing having a bellows structum 209y made of a flexible material so as to enable the wall portions to move. Ihe power supply line 32y is connected to a stator 217y of an electrical motor, said motor further comprising a rotor 218y which comprises a thread that interacts with a displaceable member 219y comprising a cormsponding thread. The displacing member is rtatably fixated to a housing contacting member 220y which pushes against the housing for affecting the volume of the stitching device and therby stoetching the stomach 12y.

[00547] Hg. 74c shows the stitching device according to fig. 10by in a second state, in which the stitching device is expanded and therby stitches the stomach wall 12y.

[00548] Hg. 75a shows an embodimentin which a device adapted to tmat rflux disease is combined with the stitching device according to any of the embodiments above. Alter invagination of the device 410 in the fundus 416, a fixation consisting of a number of stomach-to-stomach suturs or staples 422a is applied to keep the invagination intact in the short term. Asecondfixation consisting of a number of sutures or staples 422b is provided to hold the device 410 in position above the cardia 414. The sutures or staples 422b am applied between the wall of the fundus 416 and the wall of the esophagus 424y. Additionally, a third fixation in the form of sutures or staples 422cy may be provided between the wall of the fundus 416 and the diaphragm 418, again, to hold the device 410 in po sition above the cardia 414.

[00549] In this fourth embo diment depicted in g. 75a, the size of the rflux disease tmatmentdevice 410 canbe egulated while being implanted. The rflux disease tmatmentdevice 410 is associated with subcutaneous hydraulic reservoir 452 connected to the rflux disease tmatmentdevice 410, by a lead 452b whereby a non-invasive rgulation can be performed by manually pressing the rservoir 452. Passing the rservoir 452 displaces hydraulic fluid frm the reservoir 452 to the smaller chambers 410b via the lead 452b.Therflux disease tmatment device 410 is, in tum, connected to one or mom smaller chambers 410b. In this manner, the patientmay adjustthe size of therflux tmatmentdevice 410 in a manner adapted to the tmatment

[00550] iRrhermor, the embodiment above may alternatively be used to also tmat obesity. The device may, in this embodiment be adapted to trat obesity by using the volume of the rflux disease body to contain a fluid, and further using one or several smaller chambers410b connected to the device body with a pump to be filled with fluid to expand and thereby stitch the fundus wall to cmate satiety. The small chambers 41Ob a also adapted to be invaginated to in the fundus stomach wall, and when filled with fluid, an expansion of the stomach occurs that results in human sensor feedback creating satiety. The subcutaneous hydraulic reservoir/ pump enables the patient to conveniently pump hydraulic fluid to fill the small chambers 410b to cate a feeling of satiety as he or she wishes.

[00551] An alternative embodiment is shown in figure 75b. his embodiment is substantially similar to the one shown in figum 75a but differs in how the rflux treatment device 410 and chambers 410b a controlled. Here, the chambers 410b a not controlled by a subcutaneous pump but a powered internal control unit 456. The intemal control unit 456 comprises means for the patient to control the device 410 in how it shall be usedregarding treatment of flux and/ or obesity. It may also comprise means of supplying power to the device.

[00552] The intemal controlunit456 may comprise a battery 470, an electric switch 472, a motor/ pump 444, a rservoir 452, and an injection port 1001. An energy transmission device 34 with a mmote control is adapted for controlling and powering the device. 'Ihe items being selected depending on the circumstances, e.g. if the device is electrically, hydraulically, pneumatically or mechanically operated.. The device 410 may be used for keeping electronics and/ or an energy source and/ or hydraulic fluid.

[00553] Ig. 76a shows an adjustable volume filling device 810y, which is invaginated in the stomach wall of a patient's stomach 12y. 'Ihe volume filling device 81Oy is adapted to take up space in the stomach and therby reduce the volume in which food can be placed. Additionally, an adjustable stretching device y according to any of the embodiments is invaginated in the stomach fundus wall of the patient It is pferned that the volume filling device 81Oy is substantially larger than the stitching device 1Oy.

[00554] The volume filling device 810y and the stitching device 10y ar in fluid communicaon with each other via a first fluid tube 52y, in which a pump 54y is provided. The pump 54y is under the control fom an energy transforming device y, which is adapted to supply the pump 54y with energy via a power supply line 56. ihe energy transforming device 30 is also connected to a sensor 201y provided in the esophagus of the patient so thatfood intake can be detected.

[00555] The volume filling device 81Oy and the stitching device 1Oy am also in fluid communication with each other via a second fluid tube 58y, which preferably has a smaller cross-sectional ama than the firstfluid tube 52y.

[00556] ihe operation of this arrangement is as follows. The volume filling device 810y functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patien's stomach 12y. Additionally, when the stretching device 1y is enlarged by pumping fluid fim the volume filling device 810y and to the stitching device 10yby means of the pump 54y, the stomach fundus wall is strtched, crating a feeling of satiety for the patient hus, for example when food intake is detected by means of the sensor 201y, fluid is automatically pumped into the stitching device 10y to increase the feeling of satiety and therby limit the food intake.

[00557] When fluid has been injected into the stitching device 1Oy, the intemal prssum therein is higher than the intemal pressum in the volume filling device 810y. his difference in prssur will crate a flow of fluid in the second, preferably nanmwer tube 58y fim the stitching device 10y to the volume filling device 810y. The flow rate will be determined by among otherthings the difference in prssum and the cross-sectional ama of the second tube 58y. It is pferned that the second tube is so dimensioned, that the prssures in the volume filling device 810y and the stitching device 10y will rturnto equilibrium after 3 hours after fluid has been injected into the stitching device 1Oy to cmate the feeling of safety.

[00558] In this embodiment the funcon of the second tube 58y is to allow fluid to turn fim the stitching device 10y to the volume filling device 810y. Itwill be appreciated thatthis function also can be performed by the pump 54y in the fist tube 52y and thatthe second tube 58y then can be omitted.

[00559] Yet an altemaive embodiment of an apparatus for tmating obesity willnow be described with refernce to Iug. 76b, which shows a stomach 12y of a patient who is tmated for obesity. The apparatus comprises a volume filling device 810y in the form of an inflatable device 10y which is invaginated in the wall 12ay of the patient's stomach 12y. However, in this case the invaginanion has been performed in the fundus, i.e., the upper portion of the stomach, where the number of receptorsin the stomach wall is large, and the inflatable device functions as a stretching device for part of the stomach fundus wall.

[00560] A rgulation reservoir for fluids is connected to the inflatable device by means of a conduit 18y in the form of a tube.The inflatable device 81Oy is therby adapted to be gulated, preferably non-invasively, by moving liquid or air fim the rgulation rservoir to the chamber formed by the inflatable device 810y. The rgulation of the inflatable device 81Oy preferably comprises a reversed servo, i.e., a small volume is actuated for example by the patient's finger and this small volume is in connection with a larger volume, i.e., thergulation mservoir.

[00561] Thus, the inflatable device 81Oy is placed outside the stomach wall and is adapted to stitch a part of the stomach fundus wall, therby affecting the patient's appetite. By enlarging the size of the stitching device, the stomach fundus wall surrounding the inflatable stitching device 810y is stitched since the cimrumfernce of the inflatable stitching device 81Oy is increased. By this stretching, the recepton in the stomach wall indicate that the stomach is full, thereby crating a feeling of satiety to the patient Cormspondingly, when the stitching device 81Oy is contracted, the recepton indicate that the stomach is notfull, thereby rtuming the feeling of hunger. It will be appreciated that this embo diment combines the effects of both reducing the volume of the stomach food cavity and stitching part of the stomach wall 12y, therby increasing the tmatment effect

[00562] The expansion and contraction of the stitching device 81Oy can be performed under direct control of the patient Altematively, the expansion and contraction can be performed according to a p-programmed schedule.

[00563] In a prfered embodiment, shown in g. 76c, a sensor 20ly is provided at a suitable position, such as at the esophagus. The volume filling device 810y in the form of the inflatable stitching device is similar to the one shown in Hg. 76b. By providing one or mom senso, the apparatus for tmating obesity can be automated in that the size of the volume filling device 810y in the form of the inflatable stitching device is adjusted depending on the amount of food entering the food cavity of the stomach The fluid is thereby moved between the inflatable volume filling device 810y and a fluid reservoir.

System

[00564] A obesity tmatment system that can be combined with the above mentioned system for rating rflux, generally designated 28 and comprising a stretching device as described above will now be described withreference to Igs. 77-93. The system 28 can be combined with or be the same as the system 28 for treating rflux in figures 1-64.

[00565] The system of Hg. 77 comprises a stitching device 1Oy placed in the abdomen of the patient An intemal energy source in the form of an implanted energy transforming device 30 is adapted to supply energy consuming components of the obesity tratment system with energy via a power supply line 32. An extemal energy transmission device 34 includes a wireless rmote control transmitting a wireless signal, which is rceived by a signal rceiver, which may be incorporated in the implanted energy transforming device 30 or be separated themfiOm.'The implanted energy transforming device 30 transforms energy fim the signal into electric energy which is supplied via the power supply line 32.

[00566] The system of Hg. 77 is shown in a mom generalized block diagram formin g. 79, wherin the patient's skin 36, generally shown by a vertical line, separates the interior of the patient to the right of the line fim the exterior to the left of the line.

[00567] Hg. 77 shows a simplified block diagram showing the stitching device 10y, the energy transforming device 30 powering the stitching device via power supply line 32, and the extemal energy transmission device 34.

[00568] Hg. 78 shows an embodiment of the invention identical to thatof Hg. 81, exceptthata reversing device in the form of an electric switch 38 operable by polarized energy also is implanted in the patient for reversing the sttching device 10y. The wireless rmote control of the extemal energy transmission device 34 transmits a wireless signal that caries polarized energy and the implanted energy transforming device 30 transforms the wireless polarized energy into a polarized curentfor operating the electric switch 38. When the polarity of the current is shifted by the implanted energy transforming device 30 the electric switch 38 verses the function performed by the stitching device 1Oy.

[00569] Hg. 79 shows an embodimentof the invention identical to that of Hg. 78, exceptthatan operation device 40 implanted in the patientforrgulating the stitching device 10y is provided between the implanted energy transforming device 30 and the stitching device 1Oy. his operation device can be in the form of a motor 40, such as an electric servomotor. The motor 40 is powered with energy from the implanted energy transforming device 30, as the emote control of the extemal energy transmission device 34 transmits a wireless signal to the receiver of the implanted energy transforming device 30.

[00570] Ig. 80 shows an embodiment of the invention identical to that of Ig. 81, except that it also comprises an operation device is in the form of an assembly 42 including a motor/ pump unit 78 and a fluidreservoir 46 is implanted in the patient In this case the stitching device 10y is hydraulically operated, i.e. hydraulic fluid is pumped by the motor/ pump unit 44 fm the fluidreservoir 46 though a conduit48 to the stitching device 10y to operate the stitching device, and hydraulic fluid is pumped by the motor/ pump unit 44 back fim the stitching device 1Oy to the fluid reservoir 46 to turn the stretching device to a starting

position The implanted energy transforming device 30 transformis wireless energy into a current for example a polarized current for powering the motor/ pump unit 44 via an electric power supply line 50.

[00571] Instead of a hydraulically operated strtching device 10y, itis also envisaged that the operation device comprises a pneumatic operation device. In this case, pressurized air can be used for mgulaion and the fluidreservoir is placed by an air chamber and the fluid is placed by air.

[00572] In all of these embodiments the energy transforming device 30 may include a rechargeable accumulator like a battery or a capacitor to be charged by the wireless energy and supplies energy for any energy consuming part of the device.

[00573] The extemal energy transmission device 34 is preferably wireless and may include armotely conrolled control device for conrolling the device fim outside the human body.

[00574] Such a control device may include a wireless rmote control as well as a manual control of any implanted part to make contact with by the patient's hand mostlikely indimectfor example a button to prss placed under the skin

[00575] Ig. 81 shows an embodiment of the invention comprising the extemal energy transmission device 34 with its wireless rmote control, the strtching device 1Oy, in this case hydraulically operated, and the implanted energy transforming device 30, and further comprising a hydraulic fluid reservoir 52, a motor/ pump unit 44 and anreversing device in the form of a hydraulic valve shifting device 54, all implanted in the patient Of course the hydraulic operation could easily be performed by just changing the pumping direction and the hydraulic valve may therfor be omitted. The emote conrl may be a device separated fim the extemal energy transmission or included in the same. The motor of the motor/ pump unit 44 is an electric motor. In response to a control signal fim the

wireless rmote conrl of the extemal energy transmission device 34, the implanted energy transforming device 30 powers the motor/ pump unit 44 with energy fim the energy carried by the control signal, whereby the motor/ pump unit44 distributes hydraulic fluid between the hydraulic fluid reservoir 52 and the strtching device 10y. The emote control of the extemal energy transmission device 34 contrls the hydraulic valve shifting device 54 to shiftthe hydraulic fluid flow dimection between one direction in which the fluid is pumped by the motor/ pump unit44 fim the hydraulic fluid reservoir 52 to the stitching device 10y to operate the strtching device, and another opposite direction in which the fluid is pumped by the motor/ pump unit44 back fim the strtching device 10y to the hydraulic fluid reservoir 52 to turn the strtching device to a starting position

[00576] Hg. 82 shows an embodiment of the invention identical to that of Hg. 81, except that an intemal control unit56 contrlled by the wireless remote control of the extemal energy transmission device 34, an accumulator 58 and a capacitor 60 also am implanted in the patient 'Ihe intemal control unit 56 arranges storage of electric energyreceived fm the implanted energy transforming device in the accumulator 58, which supplies energy to the stitching device 1Oy. In response to a control signal fim the wireless rmote control of the extemal energy transmission device 34, the intemal control unit 56 eitherleases electric energy fim the accumulator 58 and transforms the released energy via power lines 62 and 64, or dimctly transformselectric energy fim the implanted energy transforming device 30 via a power line 66, the capacitor 60, which stabilizes the electric current a power line 68 and the power line 64, for the operation of the stoetching device 10y.

[00577] The intemal control unit is preferably programmable fim outside the patient's body. Ina prefered embodiment the intemal control unitis programmed to rgulate the stretching device 1Oy to stretch the stomach according to a p-programmed time-schedule or to input fim any sensor sensing any possible physical parameter of the patient or any functional parameter of the device.

[00578] In accordance with an alternative, the capacitor 60 in the embodiment ofHg. 18 may be omitted. In accordance with another alternative, the accumulator 58 in this embodimentmay be omitted.

[00579] Hg. 83 shows an embodiment of the invention identical to that of Hg. 77, exceptthat a battery 70 for supplying energy for the operation of the stretching device 10y and an electric switch 72 for switching the operation of the stretching device 1y also am implanted in the patient The electric switch 72 is operated by the energy supplied by the implanted energy transforming device 30 to switch fim an off mode, in which the battery 70 is not in use, to anon mode, in which the battery 70 supplies energy for the operation of the stitching device 10y.

[00580] Hg. 84 shows an embodiment of the invention identical to that of Hg. 83, except that an intemal control unit56 conrollable by the wireless rmote conrl of the extemal energy transmission device 34 also is implanted in the patient In this case, the electric switch 72 is operated by the energy supplied by the implanted energy transforming device 30 to switch fim an off mode, in which the wireless rmote control is pmvented fim conrolling the intemal conrl unit 56 and the battery is notin use, to a standby mode, in which the emote control is permitted to control the intemal conrl unit 56 to release electric energy fim the battery 70 for the operation of the stitching device 1Oy.

[00581] Hg. 85 shows an embodiment of the invention identical to that of Hg. 84, exceptthat an accumulator 58 is substituted for the battery 70 and the implanted components am interonnected differently. Inthis case, the accumulator 58 stores energy fim the implanted energy transforming device 30. In sponse to a control signal fim the wireless rmote control of the extemal energy transmission device 34, the intemal conrl unit 56 conrls the electric switch 72 to switch fim an off mode, in which the accumulator 58 is notin use, to an on mode, in which the accumulator 58 supplies energy for the operation of the strtching device 10y.

[00582] Hg. 86 shows an embodiment of the invention identical to that of Hg. 85, exceptthat a battery 70 also is implanted in the patientand the implanted components am interconnected differently. Inresponse to a control signal fim the wireless rmote conrl of the extemal energy transmission device 34, the intemal conrl unit 56 controls the accumulator 58 to deliver energy for operating the electric switch 72 to switch fim an off mode, in which the battery 70 is notin use, to an on mode, in which the battery 70 supplies electric energy for the operation of the stitching device 10y.

[00583] Altematively, the electric switch 72 may be operated by energy supplied by the accumulator 58 to switch fim an off mode, in which the wireless memote control is pmvented fim controlling the battery 70 to supply electric energy and is not in use, to a standby mode, in which the wireless mote control is permitted to contml the battery 70 to supply electric energy for the operation of the stoetching device 10y.

[00584] Itshould be understood that-the switch should be interpreted in its broadest embodiment Ihis means an IGA or a DA converter or any other electronic component or ciruit may switch power on and off preferably being controlled fim outside the body or by an intemal control unit

[00585] Hg. 87 shows an embodiment of the invention identical to that of Hg. 83, except that a motor 40, a mechanical reversing device in the form of a gear box 74, and an intemal control unit 56 for controlling the gear box 74 also ame implanted in the patient 'The intemal contml unit 56 controls the gear box 74 to reverse the function performed by the stitching device 10y (mechanically operated). Even simpler is to switch the direction of the motor electronically.

[00586] Hg. 88 shows an embodiment of the invention identical to that of Hg. 86 except-that-the implanted components ae interonnected differently. hus, inthis case the intemal controlunit56 is powered by the battery 70 whenthe accumulator 58, suitably a capacitor, activates the electric switch 72 to switch to an onmode. When the electric switch 72 is inits on mode the intemal control unit56 is permitted to control the battery 70 to supply, or not supply, energy for the operation of the stitching device 10y.

[00587] Hg. 89 schematically shows conceivable combinations of implanted components of the apparatus for achieving various communication options. Basically, there ae the stitching device 10yy, the intemal control unit 56, motor pump unit44, and the extemal energy transmission device 34 including the extemal wireless rmote conrl. As almady described above the wireless rmote control transmits a contml signal which is received by the intemal control unit 56, which in turn control the various implanted components of the apparatus.

[00588] A feedback device, preferably in the form of a sensor 76, may be implanted in the patient for sensing a physical parameter of the patient such as a contraction wave in the esophagus 203 informing the patient is eating. 'Ihe intemal conrl unit 56, or alternatively the extemal wireless rmote control of the extemal energy transmission device 34, may control the stitching device 10y in response to signals from the sensor 76. A transceiver may be combined with the sensor 76 for sending information on the sensed physical parameter to the extemal wireless memote conrl. The wireless rmote conrl may comprise a signal transmitter or transceiver and the intemal conrl unit 56 may comprise a signal rceiver or transceiver. Alternatively, the wireless rmote contml may comprise a signal rceiver or transceiver and the intemal control unit 56 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers may be used for sending information or data slated to the stretching device 1Oy fom inside the patients body to the outside therof.

[00589] Altematively, the sensor 76 may be arranged to sense a functional parameter of the strtching device 1Oy.

[00590] Where the motor/ pump unit44 and battery 70 for powering the motor/ pump unit 44 am implanted, the battery 70 may be equipped with a transceiver for sending information on the condition of the battery 70. b be mor precise, when charging a battery or accumulator with energy feedback information slated to said charging process is sent and the energy supply is changed accordingly.

[00591] Hg. 90 shows an altemaive embodiment wherein the sttching device 10y isrgulated from outside the paent's body. 'The obesity tmatment system28 comprises a stretching device 1Oy connected to a battery 70 via a subcutaneous switch 80. hus, the rgulaion of the stitching device 10y is performed non-invasively by manually pressing the subcutaneous switch, whereby the operation of the stitching device 10y is switched on and off. It will be appreciated thatthe shown embodimentis a simplification and thataddinional components, such as an intemal control unit or any other part disclosed in the present application can be added to the obesity tmatment system.

[00592] Hg. 91 shows an alternative embodiment, wheein the obesity imatment system 28 comprises a stitching device 1Oy in fluid connection with a hydraulic fluid reservoir 52. Non-invasive rgulation is performed by manually pressing the hydraulic rservoir connected to the stitching device 10y.

[00593] A further embodiment of a system according to the invention comprises a feedback device for sending information frm inside the patient's body to the outside therof to give feedback information slated to at least one functional parameter of the stitching device or system or a physical parameter of the patient therby optimizing the performance of the system.

[00594] One prfered functional parameter of the device is correlated to the transfer of energy for charging the intemal energy source.

[00595] In Hg. 92, an arrangement is schematically illustrated for supplying an accurate amount of energy to an obesity treatment system 28 implanted in a patient whose skin 36 is indicated by a vertical line. A stretching device 10y is connected to an implanted energy transforming device 30, likewise located inside the patient preferably just beneath the patient's skin 36. Generally speaking, the implanted energy transforming device 30 maybe placed in the abdomen, thorax, muscle fascia (e.g. in the abdominal wall), subcutaneously, or at any other suitable location 'he implanted energy transforming device 30 is adapted to receive wireless energy E transmitted fim an extemal energy source 34a provided in the extemal energy transmission device 34 located outside the patient's skin 36 in the vicinity of the implanted energy transforming device 30.

[00596] As is well known in the ar, the wireless energy E may generally be transferned by means of any suitable 'anscutaneous Ehergy '-ansfer (TEI device, such as a device including a primary coil arranged in the extemal energy source 34a and an adjacent secondary coil arranged in the implanted energy transforming device 30. When an electric current is fed through the primary coil, energy in the form of a voltage is induced in the secondary coil which can be used to operate a stretching device, e.g. after storing the incoming energy in an energy storing device or accumulator, such as a battery or a capacitor. However, the presentinvention is generally not limited to any particular energy transfer technique, 'IEl'devices or energy storing devices, and any kind of wireless energy may be used.

[00597] 'The amount of energy received inside the body to the device may be compared with the energy used by the device. The term used by the device is then understood to include also energy stord by the device. The amount of transfered energy can be rgulated by means of an extemal control unit 34b controlling the extemal energy source 34a based on the determined energy balance, as described above. In order to transfer the cornet amount of energy, the energy balance and the required amount of energy can be determined by means of an intemal control unit 56 connected to the stitching device 10y. The intemal control unit 56 may thus be arranged toreceive various measurements obtained by suitable sensors or the like, not shown, measuring certain characteristics of the stretching device 1Oy, somehow rflecting the required amount of energy needed for proper operation of the stitching device 1Oy. Moreover, the current condition of the patient may also be detected by means of suitable measuring devices or sensors, in order to provide parametersrflecting the patient's condition Hence, such characteristics and/ or parametersmay be slated to the current state of the stretching device 10y, such as power consumption, operational mode and temperatue, as well as the patient's condition rflected by, e.g., body temperatume, blood prssue, heartbeats and breaking.

[00598] iRrhermor, an energy storing device or accumulator 58 may optionally be connected to the implanted energy transforming device 30 for accumulating received energy for later use by the stitching device 10y. Altemaively or additionally, characteristics of such an accumulator, also reflecting the required amount of energy, may be measured as well. The accumulator may be replaced by a battery, and the measured characteristics may be slated to the current state of the battery, such as voltage, temperature, etc. In order to provide sufficientvoltage and curentto the stitching device 10y, and also to avoid excessive heating, itis clearly understood thatthe battery should be charged optimally by receiving a cormect amount of energy fim the implanted energy transforming device 30, i.e. not too little or too much he accumulator may also be a capacitor with corresponding characteristics.

[00599] Fbr example, battery characteristics may be measured on a regular basis to determine the current state of the battery, which then may be stord as state information in a suitable storage means in the intemal control unit 56. hus, whenever new measurements am made, the stored battery state information can be updated accordingly. In this way, the state of the battery can be "calibrated" by transferring a cormect amount of energy, so as to maintain the battery in an optimal condition

[00600] Thus, the intemal control unit 56 is adapted to determine the energy balance and/ or the currently required amount of energy, (either energy per time unit or accumulated energy) based on measurements made by the above-mentioned sensors or measuring devices on the stitching device 1Oy, or the patient or an energy storing device if used, or any combination thermof The intemal control unit 56 is further connected to an intemal signal transmitter 82, arranged to transmit a conrl signal rflecting the determined requird amount of energy, to an extemal signal receiver 34c connected to the external control unit 34b. The amount of energy transmitted from the extemal energy source 34a may then be rgulated in response to the mceived control signal.

[00601] Altematively, sensor measurements can be transmitted dimcty to the extemal control unit 34b wherein the energy balance and/ or the curenyrequimed amount of energy can be determined by the extemal control unit 34b, thus integrating the above-described function of the internal control unit 56 in the extemal control unit 34b. In that case, the intemal contml unit 56 can be omitted and the sensor measurements am supplied dimcty to the intemal signal transmitter 82 which sends the measumments over to the external signal rceiver 34c and the extemal control unit 34b. The energy balance and the curenty equied amount of energy can then be determined by the external control unit 34b based on those sensor measurements.

[00602] Hence, the present solution employs the feedback of information indicating the required energy, which is mom efficient than previous solutions because itis based on the actualuse of energy that's compared to the mceived energy, e.g. with respect to the amount of energy, the energy difference, or the energy receiving rate as compared to the energy rate used by the stretching device. The strtching device may use the mceived energy either for consuming or for storing the energy in an energy storage device or the like. 'Ihe different parameters discussed above would thus be used if relevant and needed and then as a tool for determining the actual energy balance. However, such parameters may also be needed per se for any actions taken internally to specifically operate the stitching device.

[00603] The internal signal transmitter 82 and the extemal signal receiver 34c may be implemented as separate units using suitable signal transfer means, such as radio, IR(Infirad) or ultrasonic signals. Alternatively, the internal signal transmitter 82 and the extemal signal receiver 34c may be integrated in the implanted energy transforming device 30 and the extemal energy source 34a, respectively, so as to convey control signals in a verse dietion mlative to the energy transfer, basically using the same transmission technique. The control signals may be modulated with respect to frequency, phase or amplitude.

[00604] ' conclude, the energy supply arrangementillustrated in IFg. 28 may operate basically in the following manner. The energy balance is first determined by the intemal control unit 56. A control signalrflecting the requimed amount of energy is also coated by the internal control unit 56, and the contml signal is transmitted fim the intemal signal transmitter 82 to the extemal signal receiver 34c. Alternatively, the energy balance can be determined by the extemal control unit 34b instead depending on the implementation, as mentioned above. In that case, the control signal may carry measurmentresults fim various sensors. The amount of energy emitted fim the extemal energy source 34a can then be regulated by the extemal contfrlunit34b, based on the determined energy balance, e.g. in response to the mceived control signal. his process may be repeated intermittently at certain intervals during ongoing energy transfer, or may be executed on a mom or less continuous basis during the energy transfer.

[00605] The amount of transferred energy can generally be rgulated by adjusting various transmission parameters in the extemal energy source 34a, such as voltage, current amplitude, wave fmquency and pulse characteristics.

[00606] A method is thus provided for controlling transmission of wireless energy supplied to an electrically operable stitching device implanted in a patient The wireless energy E is transmitted fim an extemal energy soure located outside the patient and isreceived by an intemal energyreceiver located inside the patient, the intemal energyreceiver being connected to the stitching device for dimctly or indimecty supplying received energy therto. An energy balance is determined between the energy received by the intemal energy receiver and the energy used for the stitching device. The transmission of wireless energy E from the extemal energy source is then controlled based on the determined energy balance.

[00607] A system is also provided for controlling transmission of wireless energy supplied to an electrically operable stitching device implanted in a patient The system is adapted to transmit the wireless energy E fim an extemal energy source located outside the patient which is received by an implanted energy transforming device located inside the patient the implanted energy transforming device being connected to the stitching device for dimcty or indimectly supplying received energy thereto. The systemis further adapted to determine an energy balance between the energyreceived by the implanted energy transforming device and the energy used for the stitching device, and control the transmission of wireless energy E fim the extemal energy source, based on the determined energy balance.

[00608] The functional parameter of the device is cornelated to the transfer of energy for charging the intemal energy source.

[00609] In yet an alternative embodiment the extemal source of energy is controlled fim outside the patient's body to release electromagnetic wireless energy, and released electromagnetic wireless energy is used for operating the stretching device.

[00610] In another embodiment the extemal souce of energy is conrolling fim outside the paient's body to release non-magneic wireless energy, and released non-magneic wireless energy is used for operating the stitching device.

[00611] Those skilled in the ait will ralize that the above various embodiments according to Figs. 17-29 could be combined in many diffemntways. Fbr example, the electric switch 38 operated polarized energy could be incorporated in any of the embodiments of Hgs. 11, 18-24, the hydraulic valve shifTing device 54 could be incorporated in the embodiment of Hg. 16, and the gearbox 74 could be incorporated in the embodiment ofHg. 15. Rease observe that the switch simply could mean any elecronic circuit or component

[00612] Wireless transfer of energy for operating the stitching device has been described to enable non-invasive operation It will be appreciated that the stretching device can be operated with wir bound energy as well. One such example is shown in Hg. 93, wherein an extemal switch 84 is interconnected between the extemal energy source 34a and an operation device, such as an electric motor rgulating the stitching device 10y, by means of power lines 86 and 88. An extemal control unit 34b control the operation of the extemal switch to effect prper operation of the stitching device 1Oy.

Hydraulic or pneumatic powering

[00613] Hgs. 94-97 show in mor detail block diagrams of four different ways of hydraulically or pneumatically powering an apparatus for tmating obesity according to the invention

[00614] Hg. 94 shows an apparatus for tmating obesity as described above with reference to any ofHgs. 65-70. The apparatus comprises a stitching device y and further a separate rgulation rservoir 16, a one way pump 44 and an altemate valve 54.

[00615] Hg. 95 shows the stitching device 10y and a fluidreservoir 16. By moving the wall of the gulation reservoir or changing the size of the same in any other different way, the adjustment of the stitching device may be performed without any valve, just fee passage of fluid any time by moving therservoir wall.

[00616] Hg. 96 shows the stitching device 10y, a two way pump 44 and the rgulation rservoir 16.

[00617] Hg. 97 shows a block diagram of areversed servo system with a fist closed system contrlling a second closed system.'Ihe servo system comprises a regulation rservoir 16 and a servo mservoir 90. The servo mservoir 90 mechanically controls a stitching device 10y via a mechanical interconnection 94, the stitching device having an expandable/ contactable cavity. his cavity is preferably expanded or contracted by supplying hydraulic fluid fim the larger adjustable rservoir 92 in fluid connection with the stitching device 10y. Alternatively, the cavity contains compressible gas, which can be compressed and expanded under the control of the servo mservoir 90.

[00618] The servo mservoir 90 can also be part of the stitching device itself.

[00619] In one embodiment the rgulation rservoir is placed subcutaneous under the patient's skin 36 and is operated by pushing the outer surface therof by means of a finger. his obesity treatment system is illustrated in Hgs 98a-c. In Hg. 98a, a flexible subcutaneous rgulation rservoir 16 is shown connected to a bulge shaped servo rservoir 90 by means of a conduit18. his bellow shaped servo rservoir 90 is comprised in a flexible stitching device 10y. In the state shown in Hg. 98a, the servo rservoir 90 contains a minimum of fluid andmostfluid is found in the rgulation rservoir 16. Due to the mechanical interonnection between the servo rservoir 90 and the stitching device 10y, the outer shape of the stitching device 10y is contracted, i.e., it occupies less than its maximum volume. his maximum volume is shown with dashed lines in the figure.

[00620] Hg. 98b shows a state whemein a user, such as the patientin with the stitching device is implanted, passes the rgulation rservoir 16 so that fluid contained therin is brought to flow though the conduit 18 and into the servo reservoir 90, which, thanks to its bellow shape, expands longitudinally. his expansion in turn expands the stitching device 10y so thatit occupies its maximum volume, therby stitching the stomach wall (not shown) which it contacts.

[00621] The rgulation rservoir 16 is preferably provided with means for keeping its shape after compression his means, which is schematically shown as 16a in the figure, will thus keep the stitching device 10y in a stitched position also when the user releases the rgulation reservoir. In this way, the regulation rservoir essentially operates as an on/ off switch for the obesity tmatment system.

[00622] An alternative embodiment of hydraulic or pneumatic operation will now be described with reference toIgs. 99 and 100a-c. The block diagram shown in Hg. 99 comprises with a fist closed system controlling a second clo sed system. The fist system comprises a rgulation rservoir 16 and a servo rservoir 90. The servo reservoir 90 mechanically controls a larger adjustable rservoir 92 via a mechanical interconnection 94. A sretching device 10y having an expandable/ contactable cavity is in turn controlled by the larger adjustable rservoir 92 by supply of hydraulic fluid fim the larger adjustable rservoir 92 in fluid connection with the stitching device 10y.

[00623] An example of this embodiment will now be described with refernce toIHg. 100a-c. like in the pmvious embo diment the rgulation rservoir is placed subcutaneous under the patient's skin and is operated by pushing the outer surface therof by means of a finger. The rgulation rservoir 16 is in fluid connection with a bellow shaped servo rservoir 90 by means of a conduit18. In the fist closed system16, 18, 90 shown in Fig. 34a, the servo rservoir 90 contains a minimum of fluid and mostfluid is found in thergulation reservoir 16.

[00624] The servo rservoir 90 is mechanically connected to a larger adjustable reservoir 92, in this example also having a bellow shape butwith a larger diameter than the servo rservoir 90. The larger adjustable rservoir 92 is in fluid connection with the stitching device 10y. Ihis means that when a user pushes the rgulation rservoir 16, therby displacing fluid fim the rgulation rservoir 16 to the servo reservoir 90, the expansion of the servo rservoir 90 will displace a larger volume of fluid fim the larger adjustable rservoir 92 to the stitching device 1Oy. In other words, in this reversed servo, a small volume in the regulation reservoir is compressed with a higher force and this crates a movement of a larger total ama with less force per aea unit

[00625] like in the previous embodiment described above withrefernce to Figs. 98a-c, the rgulation rservoir 16 is preferably provided with means for keeping its shape after compression. Ihis means, which is schematically shown as 16a in the figure, will thus keep the stitching device 10y in a stitched position also when the userreleases the rgulation reservoir. In this way, the rgulation rservoir essentially operates as an on/ off switch for the obesity tmatment system.

Method for the surgical treatment of a patient suffering fitim flux and obesity

[00626] A method for surgically tmating an obese patient that also suffers fim rmflux, the method comprising the steps of cutting an opening in the abdominal wall of the patient dissecting an area around the stomach, placing an apparatus for tmating to a part of the stomach wall of the patient and suturing the stomach wall.

[00627] The apparatus for tmating obesity and rflux is preferably placed in a paientvia a laparoscopic abdominal approach, comprising the steps of: inserting a needle or a tube like instrumentinto the abdomen of the paiens body, using the needle or a tube like instrumentto fill the paiens abdomen with gas thereby expanding the paienes abdominal cavity, placing atleasttwo laparoscopic rocars in the paienes body, inserting a camera through one of the laparoscopic rocars into the paienfs abdomen, inserting atleast one dissecting tool through one of said atleast two laparoscopic rocan and dissecting an intended placement ama of the patient and placing an apparatus for tmating obesity in connection with the stomach wall.

[00628] The methods could further comprise the step of postoperatively regulating the atleast one stitching device to: stretch a part;of the stomach wall and rgulate the stitching device fim outside the patient s body to affect the appetite of the patient

INSTIIJUEN'IS

[00629] An intraluminar method of invaginating a strtching device 10 on the outside of the stomach wall 12 will now be described withreference toIgs. 101ai. Initially, an instrument 600, prferably a gastroscopic instrument is inserted into the mouth of the patient see Hg. 10la. 'Ihe instrument comprises an injection device 601, 602 for injecting either fluid or a device into the stomach of the patient The instrument 600 further comprises a control unit 606 adapted for conrolling the operation of the instrument I this end, the control unit 606 comprises one or moe steering devices, in the embodiment shown in the figum in the form of two joysticks 603 and two control buttons 604. A display 605 is provided for displaying the image provided by an optical device for viewing inside the stomach, such as a camera (not shown) arranged atthe outer end of the elongated member 607, see Igs. 101ei. The camera, which may comprise connecting electrical wires extending along the elongated member, may be assisted by a light source (not shown) placed dismally on the elongated member for illuminating the inside of the stomach The optical device may also comprise optical fibers placed along the elongated member and leading out fim the patient's body for extemal viewing of the inside of the stomach

[00630] The instrument is further inserted into the esophagus and into the stomach of the patient see g. 101b. By means of the instrument 600, a hole 12by is heated in the wall of the stomach 12y. I this end, the instrument is provided with one or mom cutters 615 at the distal end therof. These cutters can of course be designed in different ways, such as a toothed drum cutterrotating about the center axis of the tube-like instrument

[00631] After cutting a hole in the stomach wall, the distal end of the instrument 600 is inserted into and through the hole 2by so that it ends up outside the stomach wall 12ay. his is shown in Hg. 101c, showing a side view of the stomach 12y, and Hg. 101d, which is a sectional view through the stomach of fig. 101c taken along the lines Vd - Vd.

[00632] The instrument600 is adapted to cmate a "caviy" or "pouch" on the outside of the stomach around the hole 12by in the stomach wall 12y. Such an instrument and the method of providing the pouch will now be described.

[00633] Hgs. 101e-i show a gastroscopic orlaparoscopic instrumentfor invaginating a stitching device 10 in the stomach wall 12 of the patient by crating a pouch of stomach wall 12 material in which the stitching device 10 is placed. The instrument generally designated 600, comprises an elongated member 607 having a proximal end and a distal end, the elongated member 607 having a diameter less than that of the patient's esophagus and being flexible such as to allow introduction of the flexible elongated member 607 with its distal end fist through the paien's throat esophagus and into the stomach 12 to the stomach wall 12a.

[00634] The stomach penetraion device or cutter 615 is provided on the elongate d member 607 at the distal en therof for penetrating the stomach wall 12a so as to cmate a hole in the stomach wall 12a, to allow introduction of the elongated member 607 through the hole. 'Ihe stomach penetration device 615 could be adapted to be operable forrmracting said stomach penetration device 615 after the stomach fundus wall 12a has been penetrated, for not further damaging tissue within the body. The instrument further comprises a special holding device 609 provided on the elongated member 607 on the proximal side to the penetration device 615.

[00635] The elongated member further comprises an expandable member 611 which is adapted to be expanded after the elongated member has penetrated the stomach wall 12a and therby assist in the craion of a cavity or pouch adapted to hold the volume filling device 610. The expandable member 611 may comprise an inflatable cirular balloon provided ciurnmferntially around the distal end portion of the flexible elongated member 60 7.

[00636] The method steps when invaginating the volume filling device will now be described in detail. After the instrument 600 has been inserted into the stomach 12, the stomach penetration device 615 is placed into contactwith the stomachwall 12, see fig. 101e. The stomach penetration device orcutter615 is thenbroughtto create the hole 12b inthe stomachwall, wheeafter atleast the expandable member 611 is brought hmugh the hole 12b in the stomach wall. The specialholding device 609 isinthis step broughtto a holding state whereinit expands radially so as to form an essentially circular abutment surface to the stomach wall 12, see Ig. 101f. In this way, the insertion of the stomach penetration device 615 and the expandable member 611 though the hole 12 in the stomach wall is limited to the position shown in fig. 101f.

[00637] The expandable member 611 is then expanded. In the case the expandable member comprises a balloon or the like, air or other fluid is injected into it

[00638] The part of the elongated member 607 comprising the expandable member 611 is then miracted in the proximal direction, as indicated by the anw in Hg. 101g, therby pulling the stomach wall 612 into a basket or cup like structum coated by the special holding device 609.

[00639] A suturing or stapling device 608 is further provided, either as a device connected to the elongated member 607 or as a separate instrument The suturing or stapling member comprises a suturing or stapling end 613 which is adapted to close the cavity or pouch by means of stomach to stomach suturs or

staples 14.

[00640] In a further step, illustrated in]Hg. 101h, aninflatable stitching device 10 is placed in its deflated state in the cup like structure. 'ihe stitching device 10 is theninflated to its inflated orexpanded state, see Hg. 101i. Ihis inflation of the stitching device 10 can be accomplished by injecting a fluid or a gel into the deflated stitching device. It can also be accomplished by injecting a material which is allowed to cue, therby forming a solid device 10. hus, the stitching device 10 shown in gs. 101h and 10 li can illustrate either a balloon like device which is subsequently filled with fluid or gel or alternatively a material which is simply injected into the cup like structum formed by the stomach wall 12.

[00641] The fluid which is used to fill the stitching device 10 could be any suitable fluid suitable to fill the stretching device 10, such as a salt solution In another embodiment when this fluid is a fluid which is adapted to be transformied into solid state, the fluid could be liquid polyurethane.

[00642] In order to minimize or entirly eliminate leakage, the fluid is iso tonic, i.e., ithas the same osmolarity as human body fluids. Another way of pmventing diffusion is to provide a fluid which comprises large molecules, such as iodine molecules.

[00643] The stomach-o-stomach suturs or staples 14 are preferably provided with fixation portions exhibiting a structure, such as a net like structure, adapted to be in contactwith the stomach wall 12 to promote growth in of human tissue to secum the long term placement of the stitching device attached to the stomach wall.

[00644] Thereby, the inflatable stitching device 10 will be in its inflated or expanded state invaginated by a stomach wall portion of the patient on the outside of the stomach wall 12.

[00645] During one or mom of the above described steps, the stomach may be inflated with gas, preferably by means of the gastroscopic instrument

[00646] The stitching device 10 described above withrefernce to Figs. 101a-i has been described as an inflatable stitching device. It will be appreciated that it also can be an elastic stitching device with an elasticity allowing compression so as to be inserted into a gastroscopic instrument and which expands to an expanded state after leaving the instrument

[00647] In one embodiment the stitching device 10 comprises an inflatable stitching device 10 expandable to an expanded state. In this case, the inflatable stitching device 10 is provided with an inlet port 18b for a fluid and is adapted to be connected to a gastroscopic instrument Ihis embodimentwill now be described in detail with eference toIgs. 102a-102d.

[00648] An inflatable stitching device in its non-expanded state is shown in Hg. 102a. Itis essentially a balloon-like, deflated stitching device 10 having an inletport 18b. In this state, the inflatable stretching device 10 has a diameter of a few millimeter at the most, allowing it to be inserted into the stomach through the esophagus of the patiently means of a gastroscopic, tube-ike instument600, or through a laparoscopic trocarin an abdominal laparoscopic method using a tube like instrument 600 depicted in figum 102b. The instrument comprises an outer sleeve 600a and an inner sleeve 600b which can be displaced longitudinally relatively to the outer sleeve. The inner sleeve is provided with a cutter in the form of a cutting edge 615 at the distal end thereof. Ihis cutting edge can be used for cutting a hole in the stomach wall, as will be explained in detail in the following.

[00649] When the instrumentreaches a stomach wall, fim the inside or outside thereof, see Hg. 102c, the inner sleeve is boughtforward fimits position in the outer sleeve and into contact with the stomach wall 12a. The cutting edge 615 of the inner sleeve then cuts a hole in the stomach wall so as to allow subsequentinsertion of the volume filling device 10 into and through this hole, see Hg. 102d. In order to push the stitching device through the hole, a piston 602 may be provided in the instrument hus, the instrument further comprises a piston 602 adapted for pushing a deflated stitching device 10 outfim a position in the inner sleeve, this position being shown in Hg. 102b, to a position outside of the inner sleeve, this being shown in Hg. 102 d.

[00650] Inorderto potect-the deflated stitching device 10 fiomthe cutting edge 615 of the innersleeve, a further protective sleeve (notshown) canbe provided around the stretching device.

[00651] Hg. 102aj shows an instrument for use in a method of engaging a stitching device 10 to the stomach wall 12 of a patient'The instruments adapted to be inserted through a nar-w tube shaped object such as a gastroscope, used in an intmluminar procedure, or a laparoscopic irocar used in a laparoscopic procedure. The instrument comprises an elongated member 650 which is adapted to be flexible by means of a construction comprising multiple ing shaped members, however itis equally conceivable that said elongated member 650 is adapted to be flexible by means of said elongated member 650 being made of a flexible or adjustable material. The elongated member 650 is inserted into the body and placed in proximity to the stomach wall 12 of the patient fim the outside or inside therof. The elongated member 650 has a special holding device 651 adapted to hold the stomach by means of mechanical grabbing members or vacuum. The special holding device 651 comprises a fistjoint652 and a second joint 653, which enables the special holding device 651 be operable in relation to the elongated member 650 and therby place the part of the holding device 651 comprising the mechanical grabbing members or vacuum elements in contact with the stomach wall 12 of the patient Hg. 102b shows the special holding device 651 when placed in contact with the stomach wall 12 of the human patient after which the special holding member 651 connects to the stomach wall 12, for holding the stomach wall 12. Hg. 102c shows the instrumentwhen the step of advancing a pushing rod 654 fim the elongated member 650 is performed. The pushing rod 654 pushes the stomach wall 12 to cmate a cavity or pouch therof. Hg. 102d shows the instrumenttued 900in relation to figs. 102a-c. his view shows the special holding members 651a,b operably attached to two sides of the elongated member 650 and being in contactwith the stomach wall 12, holding the stomach wall 12 as the pushing rod 654 pushes to cmate a cavity or pouch When the pushing rod 654 has pushed the stomach wall 12 to a desired position the special holding devices 651a,b moves towards the pushing rod 654 and therby closes the cavity or pouch

[00652] After the cavity or pouch has been crated it needs to be sealed. Ig. 103f shows the advancement of a suturing or stapling device 655 fim the elongated member 650. The suturing or stapling device 655 is positioned in connection with the stomach wall after which the suturing or stapling device commences with the suturing or stapling of the stomach wall 12, crating a seal of stomach to stomach sutures or staples 14. The instrument is moved along the stomach wall 12 of the patient and therby a cavity or pouch is created and sealed using the instrument as shown in fig. 103g and 103h When a cavity or pouch or desired size has been heated and sealed an inserting member 656 is advanced fim the elongated member 650. The inserting member 656 is adapted to insert;a stitching device 10 being inflatable, as described earlier inthis application After the inserting member 656 has been positioned in the cavity or pouch the stitching device 10 is inserted through the inserting member 656 and into the cavity or pouch by means of a pressurized fluid or gas, or a mechanical advancement member pushing said inflatable stitching device 10 into the cavity or pouch The insertion member then inflates the inflatable stitching device with a fluid or gas and seals of the final section of the pouch using stomach to stomach sutures or staples 14. The embodimentdescribed explains the process of inserting an inflatable stitching device, however it is equally conceivable that the stretching device 10 is expandable by means of the stitching device 10 being made of an elastic material.

[00653] Ig. 104a-f shows an instrumentfor use in a method of engaging a stitching device 10 to the stomach wall 12 of a patient The instruments adapted to be inserted through a nar-w tube shaped object such as a gastroscope, used in an intraluminar procedure, or a laparoscopic irocar used in a laparoscopic procedure. The instrument comprises an elongated member 660 which is adapted to be flexible by means of a construction comprising muliple ring shaped members, however itis equally conceivable that said elongated member 660 is adapted to be flexible by means of said elongated member 660 being made of a flexible or adjustable material. The elongated member 660 is inserted into the body and placed in proximity to the stomach wall 12 of the patient fim the outside or inside therof. The elongated member 660 has multiple special holding devices 661 adapted to hold the stomach by means of mechanical grabbing members or vacuum. The special holding devices 661 am locked in a position alongside the elongated member 660 by means of a locking ring 662. The special holding devices am made of a flexible material end pm-bentto expand into a funnel-shaped device when said locking ring 662 isremoved. The special holding device in its funnel shaped expandable state is shown in fig. 104b. Hg. 104b further shows the special holding device 661 when placed in contact with the stomach wall 12 of the human patient after which the special holding member 661 connects to the stomach wall 12, for holding the stomach wall 12. Hg. 104c shows the instrument when the step of advancing a pushing rod 664 fim the elongated member 660 is performed. The pushing rod 664 pushes the stomach wall 12 to cmate a cavity or pouch thereof. When the pushing rod 664 has pushed the stomach wall 12 to a desired position the special holding devices 661 moves towards the pushing rod 664 and therby closes the cavity or pouch

[00654] After the cavity or pouch has been crated it needs to be sealed. Hg. 104d shows the advancement of a suturing or stapling device 665 fim the elongated member 660. The suturing or stapling device 665 is positioned in connection with the stomach wall 12 after which the suturing or stapling device 665 commences with the suturing or stapling of the stomach wall 12, crating a seal of stomach to stomach sutures or staples 14. Thereafter an inserting member 666 is advanced fim the elongated member 660 and the special holding devices 661 am retracted. The inserting member 666 is adapted to inserta stoetching device 10 being inflatable, as described earlier in this application After the inserting member 666 has been positioned in the cavity or pouch the stitching device 10 is inserted though the inserting member 666 and into the cavity or pouch by means of a pressurized fluid or gas, or a mechanical advancement member pushing said inflatable stitching device 10 into the cavity or pouch The insertion member 656 then inflates the inflatable stitching device with a fluid or gas and seals of the final section of the pouch using stomach to stomach suturs or staples 14. The embodimentdescribed explains the process of inserting an inflatable stitching device 10, however itis equally conceivable that the stretching device 10 is expandable by means of the stitching device 10 being made of an elastic material. Ig. 40 f shows the stitching device 10 as the stitching device 10 is invaginated in the stomach wall 12, in a cavity or pouch sealed with stomach to stomach suturs or staples 14.

[00655] Ig. 105a shows an instrumentused in a method of engaging the stretching device according to any of the embodiments of the application to the stomach wall 12. The instrument comprises an elongated member 670 which is adapted to be flexible by means of a construction comprising multiple ring shaped members, however itis equally conceivable that said elongated member 670 is adapted to be flexible by means of said elongated member 670 being made of a flexible or adjustable material. The elongated member 670 is inserted into the body and placed in proximity to the stomach wall 12 of the patient fim the inside therof. A stomach penetrating member 672 is placed in the distal end of the elongated member 670, miractably fixated to a protective sleeve 673 adapted to protect the tissue of the body fim the sharp penetrating member 672 or cutter 672 after the cutting operation has been performed.

[00656] Hg. 105b shows the instrumentcomprising the elongated member 670 after the cutting operation has been performed and the stomachpenetraing member or cutter 672 has been miracted into the protective sleeve 673. A guiding wim 671 is pushed through the elongated member 670, though the hole made in the stomach wall 12 and out though the abdomen and placed on the inside of the patients skin, which is penetrated fim the outside to enable the guiding wire 671 to exit the abdomen The guiding wie 671 can then be used to guide a conduit 18 or a lead attached to the stitching device 10 being placed in the stomach fim the inside therof. The stitching device 10 with the conduit 18 or electrical lead being a stitching device 10 according to any of the embodiments of this application The guiding of the conduit 18 or electrical lead enables the attachment of the conduit 18 or electrical lead to a control unit 42 placed subcutaneously in the patient fim the outside of the abdomen

[00657] Hg. 106 shows a flowchart describing the steps needed in an intraluminar metho d of inserting an apparatus for stitching a portion of the stomach wall, the method comprises the steps of inserting an instrumentinto the esophagus 203 of the patient step la, inserting an apparatus into the stomach of the patient through the esophagus 203 using the instrument step 2a, placing the apparatus 10 in contact with the stomach wall 12, step 3a, fixating the apparatus to the stomach wall 12 such that the apparatus can stretch a part of the stomach wall 12.The method described could further comprise the step of non-invasively rgulating the device after the placing of the apparatus has been completed.

[00658] Hg. 107 shows a flowchart describing the steps needed in an abdominal method of inserting an apparatus for stitching a portion of the stomach wall, the method comprises the steps of cutting a hole in the abdominal wall of said patient step 1b, dissecting an aa around the stomach, step 2b, placing said apparatus in contact with the stomach, step 3b and fixating dimct or indirect through invagination of the stomach wall the apparatus to the stomach wall such that the apparatus can stitch a portion of said stomach wall, step 4b. The method described could further comprise the steps of closing the hole in the abdomen using suturs or staples 14 and non-invasively rgulating the device after the placing of the apparatus has been completed.

[00659] Hg. 108 shows an embodiment of an apparatus according to the invention Hg 108 shows the segments of a movementrestriction device to be assembled before implantation in a patientin the need of tmatment for arflux disease. The movement restriction device segments include a com part 560 and four outer parts 561a-561d. The generally cylindrical com partis provided with an upper part560' and is provided with four slits 562a-562d which ar symmetrically distributed end extend along the peripheral outside of the com part, 'he outer parts 561a-561s ar shown as generally being a pait of sphere having an inner and outer surface and each partis provided with a protruding flange 563a-563d extending along the inner surface. 'Ihe flanges 563a-563d matches the slits 562a 562d in the depicted embodiment butcan be arranged with loose fits between flanges and slits so the assembled movementrestriction device sufficiently is assembled atits implanted target position above the cardia. If the movement estriction device inadvertently is displaced fim this position to the stomach cavity, a loose fit arrangement contributes to a mom rapid disassembly its segments. The com paitis connected to a guiding wir 564 which extends through first channel 565 in the co pait through a cormsponding channel565a between two neighboring orifices in the prtrusion 563a in the first outer pait 561a. W hen operating on the guiding wir 564 by displacing it away fim the com partupper surface 560' the fist outer pait 561a will be displaced towards the com part and the flange 563a meets the slit562a so the fist outer parties assembled to the com pait560. As demonstrated in Hg. 109, this performance is mpeated with the second outerpart, now by the guiding wire 564 thoughthe second channel566 connected to a cormsponding channel in the flange 563b of second outer part 561b. Hg. 110 shows thisperfomance again for assembling the third outer part 561c and third channel567 connecting the guiding wire 564 to flange 563c. Hg. 111 shows the fourth and last outer part561d being assembled through flange 563d and channel 568. Hg. 112 shows the finally assembled movementrestriction device. Hg. 113a is a mor detailed view of the com partshowing the system of channels forthe guiding wire. Hg. 113b to 113d am crssectional views of planes I-,-I 111-111 and IV-IV, respectively each atthe level for four channels.

[00660] The guiding wir is made of a biodegradable material that's degraded so the segments madily become disassembled if the movementrestriction device accidently becomes displaced fimits implanted position The segments depicted are made fim a biocompatible solid material and am each of size and shape so they madily passthough the gastrointestinal systemif the movement restriction device is disassembled. When implanting the so assembled movement estriction device any of the pmviously described methods will be suitable.

[00661] Hg. 114 shows an embodiment of the movementrestriction device to be assembled. The outline of the com pait and the segments is identical as has been shown in Hg. 108, but the flanges of the segments 563a-d a provided with mecesses 563'a-d thatmatch protrusions 562'a-d of the slits 562a-d of the com pait so the assembled movement device becomes locked along two different planes. In this embodiment these planes am perpendiculary arranged. Hg. 115 shows another embodimentof the movement estriction device according toIHg. 114 without any guiding wire and without any features for the guiding wir in the segments. his embodiment requies thatmatching elementlocking elements am adapted to assist with the disassembly if the movementrestriction device inadvertently becomes displaced fim its implanted position

[00662] A method of injecting or inserting a plurality of movementrestricion device segments into a pouch formed by a part of a stomach wall will now be described with reference to Igs. 116a-d. In this example, a movementrestriction device as described above with reference to Igs. 50 will be used. A tube-ike instrument, generally designated 600, such as the one also depicted in figum 4b, comprises a sleeve 600a having a cross-sectional diameter and shape so as to allow the passage of the com part560 and the four outer parts 561a-561d. A piston 602 is provided to displace the movement estriction device segments through the sleeve 600a and into a space, wherein the movementrestriction device segments am to be assembled into or form a movementrestriction device. As shown in Ig. 116a, in this example the instrument 600 is used to insert or inject the movement restriction device segments through a hole 12a in a stomach wall portion 12 of a patient

[00663] As shown in Hg. 116b, the guiding wir 564 foes the outer parts 561a-d to take a respective positionlike petals to allow the com part560 to take a

position allowing the outerparts 561a-d and the com part560 to assemble into an essentially spherical movement estriction device 10. By pulling the guiding wire 564, see Hg. 116c, the outerparts 561a-d am moved into engagement with the com part560, being keptin position by means of the interocking flanges 563a-d.

[00664] After being fully assembled, see Ig. 116d, the essentially spherical movement restriction device 10 is invaginated inpartof the stomachwall 12 by means of sutures or staples 14. The limited space of the pouch formed by the stomach wall prevents the movement restriction device 10 fim falling apart; even after the biodegradable guiding wir 564 has been degraded. However, in the event that movement restriction device 10 comes loose, such as by the suturs or staples 14 breaking, the movement estriction device 10 falls apart so thatthe different segments, each being smaller than the assembled movement restriction device 10, can pass through the gastrointestinal system

[00665] Itis evident fim the general description and the appended claims that many of other ways designing the movement estriction device is possible without departing fim the inventive concept One such way is to let a plurality of relatively small movement estriction device segments form a movement restriction device, which will now be described with reference toIgs. 117a-c.

[00666] Ihis method of injecting or inserting movementrestriction device segments into a pouch is similar to the one described above withrefernce to Igs. 47a-d, after a pouch has beencreated in the stomach wall. hus, Hg. 117a illustrates a stomach wall portion 12a after suturs or staples 14 have been applied to crate a pouch in the stomach wall. The pouch can be provided by using the method described above with refernce to Figs. 48a-i.

[00667] Movement estriction device segments 10 am inserted or injected into the pouch by means of a gastroscopic or laparoscopic, tube-ike instrument 600, such as the one also depicted in figure 47b. The instrument comprises an outer sleeve and an inner sleeve, see Hg. 47b, which can be displaced longitudinally relatively to the outer sleeve. The inner sleeve is provided with a cutter in the form of a cutting edge 615 at the distal end therof. Ihis cutting edge can be used for cutting a hole in the stomach wall, as will be explained in detail in the following.

[00668] When the instrument aches a stomach wall, the inner sleeve is brought forward fim its position in the outer sleeve and into contactwith the stomach wall 12a. The cutting edge 615 of the inner sleeve then cuts a hole in the stomach wall so as to allow subsequent insertion of the movement restriction devices into and through this hole, see Hg. 117b. In order to push the movement estriction device through the hole, a piston 602 may be provided in the instrument

Thus, the instrument further comprises a piston 602 adapted for pushing a plurality of movement restriction devices 10 out fom a position in the inner sleeve, this position being shown in Hg. 117a, to a position outside of the inner sleeve, this being shownin]Hg. 117b.

[00669] Inorderto protectthe deflated movementrestriction device 10 fim the cutting edge 615 of the innersleeve, a further protective sleeve (notshown) can be provided around the movementrestriction device.

[00670] The tube-ike instrument600 isinthe shown embodiment provided with a cup-shaped extension keeping the pouch in place during the insertion of the movement estriction device segments 10 into the pouch By gradually withdrawing the tube-ike instrument 600 during this process, see Hg. 117b, the pouch can be filled with movement restriction device segments 10 in a controlled way.

[00671] After the pouch has been filled with movement restriction device segments to a desired degree, see Hg. 117c, the hole 12b cutin the stomach wall 12a by means of the tube-shaped instrument600 is permanently closed by means of suturing or stapling, for example.

[00672] In the embo diment shown in gs. 117a-c, the tube-like instrument 600 comprises a piston 602 adapted to push or displace the movement restriction device segments 10 along the sleeve 600b. Alternatively, as shown in Hg. 118, pmessum exerted by fluid can be used to push or displace the movementrestriction device segments 10.

[00673] The movement restriction device segments 10 can take many different shapes. In the embodiments shown in gs. 117a-c and 118, they am essentially spherical. However, in alternative embodiments, they exhibit one or a plurality of flat or essentially flat surfaces. Preferably, they then take the shape of polyhedrons, such as tetrahedrons, hexahedrons, octahedrons, dodecahedrons or ico sahedrons, i.e., regular polyhedrons with four, six, eight, twelve, and twenty flat surfaces, respecively. These examples of movement restriction device segments am shownin]Hgs. 119a-e.

[00674] The movement restriction devices can additionally be kept in their mutual mlationship by means of additional measums. Fbr example, the surfaces of the movement restriction device segments can be provided with fricion enhancing agent or material to minimize slipping of the movementrestricion device segments. The friction enhancing agent can be some kind of glue or the like. Alternatively or additionally, the surface or surfaces of the movementrestriction device segments can be given a rugged textue to increase the friction between adjacentmovement restriction device segments.

[00675] As mentioned above, the movement restriction device 10 may be inflated with a gel or fluid supplied into a chamber defined by the movement estriction device 10, see Hg. 120.

[00676] Insertion or injection of a plurality of movement restriction device segments 10 into a natuml pouch provided by a stomach wall portion 12 has been described above with refernce toIHgs. 117a-d. However, in an alternative embodiment of an apparatus for tmating obesity shown in Hg. 121, the movement restriction device segments can also comprise a movementrestriction device segment for collecting two or moe other movementrestriction device segments, which am of a differentkind. hus, the apparatus comprises an expandable second movement restriction device segment 10' for collecting two or mo first movement restriction device segments 10 different from the second movementrestriction device segment, wherein the second movement restriction device segment and the fist movement restriction device segments together form the movementrestriction device. It is prfered that the second movement restriction device segment is flexible or stoetchable.

[00677] In an altemaive embodiment to allow shaping of the movement restriction device, there may be a fricion reducing fluid to reduce the fricion between adjacent movementmrstriction device segments. In g. 122, itis shown how a plurality of movement estriction device segments 10 a provided in a pouch heated by part of a stomach wall 12 and a fluid has been injected into this pouch, which allows mutual movement between adjacent first movement restriction device segments so that the shape of the movement estriction device adapts to stomach wall movements, when said movement estriction device is invaginated in a stomach wall.

[00678] The embodiments of g. 121 and Hg. 122 may be combined, so thatan outer movement estriction device segment 10' encloses both a plurality of different in this case spherical, movement restriction device segments 10 as well as a fluid, which reduces the fricion between the different movement estricion device segments.

[00679] The fluid described above may, instead ofreducing the friction between adjacent movement estriction device segments, enhance the friction between adjacent movement estriction device segments, thus making the movement restriction device moe stable. The friction enhancing material may also be a glue or an adhesive, i.e., a solidifying liquid.

[00680] Movementmstriction device segments adapted to be used in a plurality to form a movement estriction device have been described above with reference toIgs. 116a-c and 119a-e. Itwill be appreciated thatthese movement restriction device segments can be given the same properties as the movement restriction devices described earlier mgarding materials, properties etc.

[00681] Itis evident frm the general description and the appended claims that many of other ways designing the movementrestriction device is possible without departing frm this concept

[00682] Rease note that all the embodiments or features of an embodiment as well as any method or step of a method could be combined in any way if such combination is notclearly contradictory. Rease also note thatthe description in general should be seen as describing both an apparatus and a device adapted to perform a method as well as this method in itself.

[00683] A method or part of method to be used in any combination and using any apparatus or part of apparatus or any featum in any combination where the following method steps is applicable , whemein said method may comprise one or mom of the following operational method steps:

• introducing said instrumentinto the th at

• passing down the esophagus,

• placing an anvil or unit for delivery of fixating members in the esophagus

between the cardia and the diaphragmlevel, for engaging in the fixation of the esophagus to the stomach tissue,

• passing down the esophagus and additionally further down into the

stomach,

• filling the stomach with gas to expand the stomach,

• sucking fluid frm the stomach,

• looking at a guiding vision when said instrument comprising a camera,

• engaging the instrument with the stomach,

• crating and suturing atleast one pouch of the stomach wall,

two or mom volume filling devices,

• passing through the stomach wall with said instrument

• passing through the stomach wall with said instrument for the placement of a volume filling device on the outside of the stomach wall,

• passing through the stomach wall with said instrument for the placement of a tube allowing placement of a subcutaneous injection port;

• placing an subcutaneous injection port;

• suturing or stapling the stomach wall fim the inside therof to the

esophagus,

• suturing or stapling the stomach wall to stomach wall fim the inside of the

stomach,

• engaging the instrument with the esophagus,

• suturing or stapling one layer of stomach tissue to one layer of esophageal

tissue,

• suturing or stapling two layer of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling there layers of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling four layers of stomach tissue to one layer of esophageal tissue,

• suturing or stapling one or mom layers of stomach tissue to two or more positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in elation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a fist point along a fist esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance fim said fist esophagus surface length axis, radially inrlation to said esophagus center axis,

• delivering fixating members by a unit placed on said instrument,

• placing said fixating members above the gastro-esophagealjunction for

crating a tunnel between the esophagus and stomach above said junction,

• placing an esophagus part in the esophagus and a stomach part in the

stomach,

• placing the fixating member substantially between the stomach and

esophagus part,

• inserting said instrument into the main stomach cavity through the cardia

and adapted to dimectthe instrumentin cranial direction to reach a position of said unit above said junction, allowing the tunnel a substantially unestricted contraction and release of the cardia closing sphincter muscle placed in said junction, when such a tunnel has beencreated.

[00684] A method or part of method to be used in any combination and using any apparatus or part of apparatus or any featum in any combination where the following method steps is applicable , wherein said method comprises one or mom of the following operational method steps:

• cutting the skin of a patient

• crating an opening in the abdominal wall of the patient

• Introducing said instrument into the abdominal cavity through said opening

in the abdominal wall,

• engaging the instrument with the stomach,

• pulling down into the stomach wall for creating atleast one pr-shaped

pouch of the stomach wall,

• clamping the stomach wall for creating atleast one pr-shaped pouch of

the stomach wall,

• suturing or stapling at least one pouch in the stomach wall,

two or mom volume filling devices,

stomach tissue through a tubular member,

• passing through the stomach wall into the stomach with said instrument,

• passing through the stomach wall with said instrument for the placement of

a volume filling device on the inside of the stomach wall,

• passing through the stomach wall with said instrument for suturing the

stomach wall to the esophagus wall,

• placing a volume filling device on the outside of the stomach wall,

• invaginating said volume filling device in the stomach wall

• placing a subcutaneous injection port

• suturing or stapling the stomach wall to stomach wall fiom the outside of

the stomach,

• suturing or stapling the stomach wall to stomach wall fim the outside of

the stomach without penetrating the mucosa,

• engaging the instrument with the esophagus,

• clamping the on both sides of the esophagus for fixating one layer of

esophageal wall to stomach tissue,

• clamping the on both sides of the esophagus and the stomach fundus wall

• introducing a tube or a gastroscopic instrumentinto the esophagus

comprising an anvil member or a fixating delivery member involving in the fixation of the esophagus to the stomach,

• coordinating the position of the anvil member or a fixating delivery

member inside the esophagus to said instrument clamping around the esophagus,

• sutuing or stapling one layer of stomach tissue to one layer of esophageal

tissue,

• suturing or stapling there layers of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling four layers of stomach tissue to one layer of

esophageal tissue,

a stapler row,

• stapling stomach to esophagus with one fist stapler depth and stapling stomach to stomach with a second smaller stapler depth,

• stapling a pouch with stomach to stomach suturs in a staplerrow, further

• suturing or stapling one or mom layers of stomach tissue to two or mor

positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in relation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a fist point along a fist esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance fim said fist esophagus surface length axis, radially in elation to said esophagus center axis,

• delivering fixating members by a unit placed on said instrument,

• placing said fixating members above the gastro-esophagealjunction for

crating a tunnel between the esophagus and stomach above said junction,

• allowing the tunnel a substantially unestricted contraction and release of

• placing an esophagus part in the esophagus and a stomach part in the

stomach via an introduction into the stomach cavity,

• placing the fixating member substantially between the stomach and

esophagus part,

• inserting said instrument into the main stomach cavity below said junction

and adapted to direct the instrumentin cranial direction to mach a position of said unit above said junction,

• operating a joint comprised in said instrument, for enabling said

instrument to be inserted into the main stomach cavity bending said jointin a direction to mach a position of said part of the unitin the esophagus above said junction.

[00685] A method or part of method to be used in any combination and using any apparatus or part of apparatus or any featum in any combination when the following method steps is applicable, whemin said method comprises one or mom of the following lapanscopic operational method steps:

• cutting the skin of a patient

• intrducing a tube though the abdominal wall,

• filling a fluid or gas into the abdominal cavity,

• intducing two or mom tocarsm into the abdominal cavity,

• intrducing a camera into the abdominal cavity though one of the cas,

• intrducing said instrumentinto the abdominal cavity though a car,

• engaging the instrument with the stomach,

• pulling down into the stomach wall for creating atleast one pm-shaped

pouch of the stomach wall,

• clamping the stomach wall for cmating atleastone pm-shaped pouch of the stomach wall,

• suturing or stapling at least one pouch in the stomach wall,

or two or mom volume filling devices,

stomach tissue though a tubular member,

• passing though the stomach wall into the stomach with said instrument,

• passing through the stomach wall with said instrument for the placement of

a volume filling device on the inside of the stomach wall,

• passing through the stomach wall with said instrument for suturing the

stomach wall to the esophagus wall,

• placing a volume filling device on the outside of the stomach wall,

• invaginating said volume filling device in the stomach wall

• placing a subcutaneous injection port;

• suturing or stapling the stomach wall to stomach wall fim the outside of

the stomach,

• suturing or stapling two layers of stomach wall to one or two layers of

stomach wall,

• suturing or stapling the stomach wall to stomach wall fim the outside of the stomach without penetrating the mucosa,

• engaging the instrument with the esophagus,

• clamping the on both sides of the esophagus for fixating one layer of

esophageal wall to stomach tissue,

• clamping the on both sides of the esophagus and the stomach fundus wall

• introducing a tube or a gastroscopic instrumentinto the esophagus

• suturing or stapling one layer of stomach tissue to one layer of esophageal

tissue,

• suturing or stapling there layers of stomach tissue to one layer of

esophageal tissue,

• suturing or stapling four layers of stomach tissue to one layer of

esophageal tissue,

a stapler row,

• stapling a pouch with stomach to stomach suturs in a staplerrow, further

• suturing or stapling one or mom layers of stomach tissue to two or mor

positions on the esophageal tissue, the esophagus having an esophagus center axis, the esophagus further having an inner and outer substantially cylindrical surface extending radially in relation to the esophagus center axis and wherein the stomach tissue is attached to esophageal tissue both at a fist point along a first esophagus surface length axis, substantially parallel to said esophagus center axis and at a second point along a second esophagus surface length axis, substantially parallel to said esophagus center axis, at a distance fim said fist esophagus surface length axis, radially in elation to said esophagus center axis,

• delivering fixating members by a unit placed on said instrument,

• placing said fixating members above the gastro-esophagealjunction for

crating a tunnel between the esophagus and stomach above said junction,

• allowing the tunnel a substantially unestricted contraction and release of

• placing an esophagus part in the esophagus and a stomach part in the

stomach via an introduction into the stomach cavity,

• placing the fixating member substantially between the stomach and

esophagus part;

• inserting said instrument into the main stomach cavity below said junction

• operating a joint comprised in said instrument, for enabling said

Please note that any embodiment or part of embodiment as well as any

method or part of method or any apparatus or part of apparatus or any feature or part of

feature or any system or part of system could be combined in any applicable way. All

examples herein should be seen as part of the general description and therefore possible to

combine in any way in general terms.

While specific embodiments of the invention have been illustrated and

described herein, it is realized that numerous other embodiments may be envisaged and that

numerous additional advantages, modifications and changes will readily occur to those

skilled in the art without departing from the spirit and scope of the invention. Therefore, the

invention in its broader aspects is not limited to the specific details, representative devices

and illustrated examples shown and described herein. Accordingly, various modifications

may be made without departing from the spirit or scope of the general inventive concept as

defined by the appended claims and their equivalents. It is therefore to be understood that

the appended claims are intended to cover all such modifications and changes as fall within

a true spirit and scope of the invention. Numerous other embodiments may be envisaged

without departing from the spirit and scope of the invention.

The present application is divided from Australian Patent No. 2018267675, the content of

which is incorporated herein in its entirety by reference.

Claims

1. An intraluminar method of treating a reflux disease in a patient by implanting a device

comprising an implantable movement restriction device that, when implanted in a patient,

restricts the movement of the cardiac notch in relation to the diaphragm muscle, preventing the

cardia from sliding through the esophageal hiatus, the implantable movement restriction device

comprising at least two segments, the intraluminar method comprising:

introducing an instrument through the esophagus and into the stomach of the patient,

introducing the implantable movement restriction device through the esophagus using

said instrument;

invaginating the implantable movement restriction device by a portion of the fundus wall,

such that an outer surface of the movement restriction device rests against a surface of the fundus

wall; and

affixing the invaginated movement restriction device to the fundus wall, thereby

preventing the cardia from sliding through the esophageal hiatus and thus reducing reflux

disease.

2. The method according to claim 1, further comprising;

creating, using a surgical instrument, a pouch in a portion of the stomach fundus wall on

the outside of the stomach cavity, and

invaginating the implantable movement restriction device in the pouch.

3. The method according to claim 2, further comprising:

creating a hole in the stomach wall of the patient, using said instrument.

4. The method according to claim 1, further comprising;

the inside of the stomach cavity, and

invaginating the implantable movement restriction device in the pouch.

5. The method according to claim 1, further comprising inflating the implantable

movement restriction device to its filling volume.

6. The method according to claim 1, wherein the step of affixing the implantable

movement restriction device to the fundus wall comprises affixing the movement restriction

device using sutures or staples.

7. The method according to claim 1, further comprising affixing the fundus wall to the

lower part of the patient's esophagus.

8. The method according to claim 7, wherein the step of affixing the fundus wall to the

lower part of the patient's esophagus comprises affixing the fundus wall to the lower part of the

patient's esophagus by providing sutures or staples.

9. The method according to claim 1, further comprising affixing the fundus wall to the

patient's diaphragm muscle or associated muscles.

10. The method according to claim 9, wherein the step of affixing the fundus wall to the

patient's diaphragm muscle or associated muscles comprises affixing the stomach fundus wall to

the patient's diaphragm muscle or associated muscles by providing sutures or staples.

11. The method according to claim 1, further comprising providing an apparatus for

regulating the movement restriction device from the outside of the patient's body.

12. The method according to claim 11, wherein the step of providing an apparatus for

regulating the movement restriction device from the outside of the patient's body comprises

providing an injection port configured to allow the volume of the movement restriction device to

be regulated by percutaneous injections.

13. The method according to claim 12, wherein the step of providing an injection port

further comprises fixating said injection subcutaneously in the patient's body.

14. The method according to claim 1, further comprising the step of pushing the fundus

and cardia into its correct position below the diaphragm, using an instrument placed in the

patient's esophagus.

15. The method according to claim 4, wherein creating a pouch in a portion of the

stomach fundus wall comprises creating a pouch having a volume of more than 15 millilitres.

16. The method according to claim 4, wherein creating a pouch in a portion of the

17. The method according to claim 4, further comprising affixing the pouch to the lower

part of the patient's esophagus.

18. The method according to claim 4, further comprising affixing the pouch to the

patient's diaphragm muscle or associated muscles.

19. The method according to claim 1, wherein the implantable movement restriction

device comprises a fixation member, and wherein the step of affixing the movement restriction

device to the fundus wall comprises affixing the fixation member to the fundus wall.

20. The method according to claim 1, wherein the implantable movement restriction

device comprises a fluid conduit, and wherein the method further comprising tunneling the fluid

conduit in the stomach wall.