CN100556477C - Bariatric device and method - Google Patents

Bariatric device and method Download PDF

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Publication number
CN100556477C
CN100556477C CNB2005800396258A CN200580039625A CN100556477C CN 100556477 C CN100556477 C CN 100556477C CN B2005800396258 A CNB2005800396258 A CN B2005800396258A CN 200580039625 A CN200580039625 A CN 200580039625A CN 100556477 C CN100556477 C CN 100556477C
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bariatric device
wall
patient
radial pressure
main body
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CN101060880A (en
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R·S·贝克尔
P·R·肯密特
J·A·富特
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BFKW LLC
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BFKW LLC
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Abstract

The Bariatric device of generation satietion and method comprise in the patient provides the main body with the wall that defines the chamber.The customization wall make itself and patient's esophagus abdomen section and/or be positioned at esophageal-gastric junction and/or the shape of the nearly pars cardiaca of patient's stomach with big or small similar.Make wall suitable esophagus abdomen section and/or esophageal-gastric junction and/or proximal gastric or cardia generation radial pressure to the patient.This pressure influence is present in the neuro hormone feedback mechanism of esophagus far-end and cardia, thereby by strengthening the distension that causes by food and under the non-existent situation of food, stimulating distension to produce to the small part satietion.

Description

Bariatric device and method
Invention field
The present invention relates in the patient, to cause Bariatric device and method to the small part satietion.Especially, the present invention relates in the patient, cause Bariatric device and method to the small part satietion by Noninvasive or bottom line invasive technique.
Background of invention
Obesity is a huge and ever-increasing problem in the U.S. and world wide.With a big approximate number, in the period about period to 2000 from about the nineteen ninety year, the prevalence rate of overweight people (BMI is greater than 25) increases to 65% from U.S. adult's 56%, and fat adult's (BMI is greater than 30) prevalence rate increases to 30% from 23%.Equally, the prevalence rate of prevalence of overweight children and teenager (age 6-19 year) from about the nineteen ninety period 11% increase to 16% of left and right sides period in 2000.Ever-increasing overweight prevalence rate makes that problem is more serious when it is adult in child and the teenager.This problem is not limited to the U.S..European male overweight between 10% and 20%, the European women obesity between 10% and 25%.Many medical conditions comprise that type ii diabetes, apoplexy, gallbladder disease and various forms of cancer worsen because of obesity.According to estimates, die from the disease relevant with obesity in North America and annual about 500,000 people in West Europe, obesity worldwide influences and surpasses 1,000,000,000 adults according to estimates.Therefore, exist solving the urgent and unsatisfied needs of this popularity problem.
Become known in the patient, reducing the various technology of obesity.Known technology is tended to based on erstricted diet motion and/or alimentation.An example is the high invasive gastric bypass that the patient is carried out.The purpose of this operation is to accept the spatial volume of food from the part formation sack of stomach to reduce stomach.When patient's dietary intake, this sack is filled, and it stretches coat of the stomach and produces satietion.The difficulty that this method runs into is that it needs food to fill described sack to produce satietion.As a result, the effective operation for this sack needs dietary restrictions.These restrictions are included in during the dining limit fluid and take in avoiding food is gone out from bag.In addition, has sufficient caloric liquid inclination in not producing sufficient satietion by described sack.In addition, it is big that the sack opening of passing in time tends to become, thereby allow the satietion of more food by obtaining to reduce.Therefore, experience the common passage experience in time of the human patients weight increase gradually of this surgical technic.
The selectable apparatus and method that lose weight have been proposed.Yet these apparatus and method may be difficult to insert in patient's body, and its effect is unreliable, and can cause undesired side effect.
General introduction of the present invention
The present invention uses the new principle of implied satietion (implied satietion).The invention provides the Bariatric device and the method that cause producing satietion in the patient, described apparatus and method strengthen the natural response of health.This can use Noninvasive or the invasive method of bottom line to realize by with removable or absorbable device.In addition, can not disturb the mode of for example normal anti-stream mechanism of other body functions, the operation of bile duct, the absorption of medicine etc. to produce satietion.Implied satietion technique of the present invention does not rely on the restricted technology or the malabsorption technology of prior art.
According to aspects of the present invention, Bariatric device comprises the main body with the wall that defines the chamber.Customize described wall and make it similar greatly with size: i) esophagus abdomen section to the shape at one or more following positions; Ii) esophageal-gastric junction; And/or the iii) nearly pars cardiaca of stomach, be also referred to as cardia.Make wall be fit to one or more positions are produced radial pressure, described position is i) esophagus abdomen section; Ii) esophageal-gastric junction; And/or the nearly pars cardiaca of stomach.Like this, described Bariatric device influences patient's neuro hormone feedback mechanism, thereby produces the satietion to small part.This can be by strengthening the distension that is caused by food and stimulating distension to realize under the non-existent situation of food.
The main body of Bariatric device can be elongated and is asymmetric in the vertical along the longitudinal axis.This main body can comprise being radially asymmetric part with respect to the longitudinal axis at least.The wall of customizable any above-mentioned Bariatric device makes it shape and the big or small broadly similar with the nearly pars cardiaca of the abdomen section of esophagus, esophageal-gastric junction stomach function regulating.The nearly pars cardiaca of the abdomen section stomach function regulating of esophagus produces radial pressure to make this wall be adapted at least.
Above shown in the main body of arbitrary Bariatric device can have first and second parts.First how much parts are normally columniform, and second how much parts are normally Frusto-conical.Above shown in the wall of any Bariatric device comprise the non-basically self expandable formula part that is fit to produce the self expandable formula part of radial pressure and is suitable for not producing radial pressure.This non-self expandable formula partly is fit to place the gastroesophageal sphincter place.
Can make the wall of each Bariatric device in the claim of front be fit to produce overall constant radial pressure or be fit to produce adjustable radial pressure.Can produce variable radial pressure by the chamber in the wall, the radial pressure that the many fluid regulation in the wherein said chamber are produced by wall.Such device can comprise the hole that external path is provided to cell.This device can comprise the controller of suitable control by the size of the radial pressure of wall generation.Described controller can be suitable for temporary transient size of regulating the radial pressure that is produced by wall.Like this, as an example, controller can make device that abdominal esophagus, stomach esophageal junction and/or cardia are produced radial pressure in the normal awake time, makes wall lax to reduce the pressure that produces significantly in the non-awake time when not needing satietion simultaneously.This controller has obtained useful results, comprises overcoming any potential tachyphylaxis (tachy phylaxis), and under this tachyphylaxis, passage in time, for the radial pressure of giving sizing, this device can obtain the recovery that reduces gradually of satietion.This can produce bigger radial pressure and ought be when not required by making wall during one day critical period, the interim adjustment that reduces radial pressure realizes.
Above shown in any Bariatric device can comprise the fixed system of the distal migration that be fit to stop main body.The metal anchors that this fixed system can comprise barb, V-arrangement adnexa, radially extend from main body, bail, suture etc.This fixed system can comprise inflatable bladder.Mechanism of ammonium fixation can comprise main body to small part, this part is suitable for promoting tissue ingrowth.This part can comprise series of openings in the part of main body.These openings can be the different opening of series or the dot matrix of littler opening.Fixed system can be positioned at the part of the wall that is suitable for being placed in esophageal-gastric junction.
Above shown in any Bariatric device can comprise prevention from the chamber effusive limiter.This limiter can be adjustable limiter.This adjustable limiter can comprise fluid reservoir, and this reservoir can be regulated by the fluid that changes in the reservoir.This adjustable limiter can be by being used for adding or regulating from the electronic-controlled installation that reservoir is removed fluidic via hole and/or is used to control the fluidic amount of reservoir.
Above shown in any Bariatric device can comprise the chamber of length less than 9cm.This chamber can have the length of scope between about 6cm and about 7cm.
According to aspects of the present invention, in the patient, cause comprising main body with the wall that defines the chamber and at least one position that this main body is placed following position are provided: i) esophagus abdomen section to the method for small part satietion; Ii) esophageal-gastric junction and/or the iii) nearly pars cardiaca of stomach.With wall at least one following position is produced radial pressure: i) esophagus abdomen section; Ii) esophageal-gastric junction and/or the iii) nearly pars cardiaca of stomach.Radial pressure influences patient's neuro hormone feedback mechanism.This is by strengthening the distension that is caused by food and stimulating distension to produce to the small part satietion under the non-existent situation of food.
Main body can place the nearly pars cardiaca of esophagus abdomen section, esophageal-gastric junction stomach function regulating, and by wall the nearly pars cardiaca of esophagus abdomen section stomach function regulating is at least produced radial pressure.Can fully lax part be provided and this part that fully relaxes is placed the interference of gastroesophageal sphincter with minimizing patient's anti-reflux mechanism to wall.
Above shown in any aspect can comprise main body is fixed to the patient to stop the distal migration of main body.This can comprise main body is fixed on esophageal-gastric junction.Should fixing can comprise and promote tissue inwardly to grow by the wall of main body.
In arbitrary method in the above, the radial pressure that is produced can comprise that producing overall constant radial pressure maybe can comprise the adjustable radial pressure of generation.Can be by regulating pressure by peritoneoscope or by for example Intraabdominal controller adjusting pressure produces adjustable radial pressure in patient's body with placing at least in part.Can for example regulate pressure according to the pressure of parameter adjusting at that time by between the sleep period of expection, reducing pressure.This has obtained useful results, comprises overcoming any potential tachyphylaxis, i.e. and passage in time, this tachyphylaxis can reduce from the satietion of the radial pressure acquisition of specified quantitative.Therefore, in some stage, for example when the patient wakes up, can apply bigger radial pressure, and between sleep period, when not needing satietion, can reduce pressure.In addition, pressure can change with the time that patient in a day has meal.
Above shown in arbitrary method can comprise the patient's that monitoring is caused by the generation of radial pressure satietion.This monitoring can comprise the satietion of monitoring main body patient during the intravital expansion of patient.Can select the function of radial pressure as this monitoring.Described monitoring can comprise the hypothalamic mobility of monitoring as the patient of the indicator of satietion, and described satietion is inductive in patient's body by the running of the nearly pars cardiaca neuro hormone feedback mechanism that is present in abdominal esophagus, esophageal-gastric junction and/or stomach.
Above shown in arbitrary method can comprise at least main body begin use antinanseant to the patient during launching.This is to feel sick in order to overcome cause when being launched in patient's body by main body at least at first any potential.Above shown in either side can comprise extraly to the patient and use nutritional supplement to guarantee in the patient, not cause patient's undernutrition to the generation of small part satietion.This nutritional supplement can comprise, as an example, and protein supplements.In arbitrary method in the above, can comprise fluoroscopic assist by location and this location that peritoneoscope carries out main body.
Therefore, the invention provides the machine-processed implied satietion device (implied satietor) of satietion and the method for implied satietion of producing of neuro hormone that does not need food but pass through main body as can be seen.This advantageously produces in the patient to the small part satietion under the non-existent situation of food, also increases the distension that is produced by food during ingesting.In addition, because satietion is not produced by food, so the patient do not need to accept dietary restrictions, for example fasting fluid or prohibit kitchenware sufficient caloric fluid is arranged during having meal.In addition, opposite with operation method, the invention provides the Bariatric device and the method that cause to the small part satietion, described apparatus and method are that bottom line is invasive and avoided for example many potential side effect of adjustable gastric bands etc. of gastric bypass and other operation methods.In addition, because the placement of device, so to for example not interference such as operation of bile duct of stomach function.The present invention also provides Bariatric device and the method that is induced to the small part satietion in the patient in addition, and described apparatus and method are not based on and cause the patient working on the basis of flu-like symptoms with the obstruction effort of attempting to induce the patient to eat (the medium generation of duodenum that for example can be by device being put into the patient) less.
The pouch that forms with gastric bypass is opposite in addition, and the present invention does not comprise passs in time and be easy to become big floss hole, is present in the source that the body weight among the patient who experiences gastric bypass increases gradually thereby eliminated at least one.
In addition, because it is the invasive method of Noninvasive or bottom line,, also can be used for obese patient, overweight patient, teenager and potential even child so the present invention not only can be used for MO patient.
Therefore, can see that invention provides Bariatric device and the method that comprises the main body with extensible wall, this wall can evoke the normal neuro hormone reaction relevant with distension or satietion.Described main wall applies by the one or more parts to patient's distal esophagus and/or cardia and is used for carrying out this function.The normal sensation of fullness of stomach obtains increasing and enlarging.
According to following description and accompanying drawing, these and other purposes of the present invention, favourable aspect and feature will become obvious.
Summary of drawings
Fig. 1 is the diagram of Bariatric device of the nearly pars cardiaca of the esophagus abdomen section that places the patient, esophageal-gastric junction stomach function regulating;
Fig. 2 is the perspective view of the selectable embodiment of the Bariatric device among Fig. 1;
Fig. 3 is the bottom plan view of the Bariatric device among Fig. 2;
Fig. 4 is the view with another alternate embodiment identical with Fig. 2;
Fig. 5 is the view that illustrates selectable control technology identical with Fig. 4;
Fig. 6 is the view of another the selectable embodiment identical with Fig. 2;
Fig. 7 is the view of the adjusting that illustrate restriction identical with Fig. 6;
Fig. 8 is the view of another the selectable embodiment identical with Fig. 2;
Fig. 9 is the view of another the selectable embodiment identical with Fig. 2;
Figure 10 is the view of another the selectable embodiment identical with Fig. 1;
Figure 11 is the view of another the selectable embodiment identical with Fig. 1;
Figure 12 is the view of another the selectable embodiment identical with Fig. 2;
Figure 13 is the view of another the selectable embodiment identical with Fig. 2;
Figure 14 is the view of another the selectable embodiment identical with Fig. 2; With
Figure 15 is the block diagram of technology that is used to select the level of the radial pressure that produced by main wall.
The description of preferred embodiment
Now in particular with reference to accompanying drawing, in Fig. 1 illustrated place the intravital illustrative embodiment described herein of patient, Bariatric device or implied satietion device 15, described device produces satietion by the nearly pars cardiaca effect to esophagus abdomen section and/or esophageal-gastric junction stomach function regulating.Device 15 comprises main body 16, but this main body has the wall 17 (defining interconnection or chamber 18 by main body by it) of radial dilatation.Design agents 16 makes the shape of the nearly pars cardiaca of itself and patient's esophagus abdomen section and/or esophageal-gastric junction stomach function regulating or cardia similar with size.Embody the present invention with various Bariatric devices.Described device can be removable, absorbable and/or nonvolatil.Described device can be by synthetic material or bioprosthetic material manufacturing.Although with the sieve wall the present invention is described, other configurations for example coil configurations etc. also are possible.The peritoneoscope that can use various technology for example to have fluoroscopic assist is placed art and is settled Bariatric device 15.
The configuration of moulding wall 17 makes its esophagus abdomen section the patient, esophageal-gastric junction and/or cardia produce radial pressure.This can be by for example moulding wall to make it to have close end 17a to produce and the interference fit of esophagus abdomen section and/or through moulding to produce and the middle body 17b of the interference fit of esophageal-gastric junction and/or through moulding the distal portions 17c with the interference fit of generation and patient's cardia.The pressure influence that produces by wall part 17a, 17b and/or 17c is present in the neuro hormone feedback mechanism in esophagus and/or the stomach, thereby produces the satietion to small part.As be described in greater detail below, the pressure that produces by distensible wall constant or adjustable.The pressure that influences the neuro hormone feedback mechanism of the pars cardiaca that is present in esophagus abdomen section, esophageal-gastric junction and/or stomach tends to constant relatively in as far as possible suitably big zone.The pressure that is produced by the wall of Bariatric device it is believed that and activated the stretch receptor that is arranged in esophagus abdomen section, esophagus connecting portion and/or cardia.Opposite with the device of the hormone feedback mechanism that affects the nerves with the previously mentioned patient's of needs dietary intake, Bariatric device 15 stimulates distension lacking under the situation of food.It also strengthens the distension that is caused by food.
This interference fit can be by the wall generation of stretching, extension or self expandable certainly.Selectively, it can be by for example balloon expandable formula wall generation of distensible wall.The diameter of the wall of selection expansion is so that its diameter than the conduit of wherein having placed it (being esophagus abdomen section, esophageal-gastric junction and/or cardia) is big slightly.Self expandable formula wall can be, as an example, and from the laser cut of nitinol sheet, or can be by the material manufacture of self expandable formula SC.Selectively, can radially wall be expanded outwardly to the position of withstanding conduit (wherein having inserted main body) wall massively by sacculus or liquid expansion reservoir and expand wall.This expansion can by peritoneoscope with blunt pin or with will be below in greater detail controller finish.
As seeing in Fig. 1, with respect to the central longitudinal axis of being determined along patient's esophagus stomach function regulating travel direction by food " L ", wall 17 is asymmetric in the vertical.Especially, when when axle L moves, the cross sectional configuration of wall 17 changes from near-end to far-end.For example, wall part 17a and 17b are normally columniform in shape, and the shape of wall part 17c is a conical butt, and the outside flare of the far-end of wall part 17b is opened.Make wall part 17c bending at angle to coincide with cardiac incisure.This longitudinal axis of phase DIYU " L ", wall 17 also can be radially asymmetric.Especially, some part of wall 17 is compared with the part of wall that is positioned at around the diverse location of axle L, be in bigger from the diameter of axle to distance.For example, wall part 17c enlarges its turning for example, more bottom extend to cardia 19.The part 19 of this expansion makes wall 17 be radially asymmetric with respect to axle " L ".
Narrow of chamber 18 (being generally the part in patient's the esophagus) can have the radial pressure that no longer needs to provide enough to produce the length of satietion.In illustrational embodiment, the narrow portion in chamber 18 is shorter than 9cm on length.In certain embodiments, in the scope of the length of the narrow portion in chamber 18 between 6cm and 7cm.Thereby when producing radial pressure produce satietion on competent surface area, this reduces food and is captured into the trend in chamber and has reduced interference to esophageal peristalsis.
In the embodiment of Fig. 1 illustrated, in the patient, cause the Bariatric device 15 of satietion and corresponding method to comprise the part 20 that middle at least wall part 17b is provided, described part 20 does not produce tangible radial pressure or power.This part can be for example non-from expanding material manufacture by lax material.Place described device like this so that described slack 20 covers gastroesophageal sphincter.This can make the anti-reflux mechanism operation normally usually of stomach esophageal junction, because the wall of part 20 does not produce any tangible radial pressure to sphincter.This embodiment makes patient belch, vomiting etc. when anti-reflux.In Bariatric device 15, proximal end wall part 17a be self expandable and usually in shape for cylindrical, thereby it is similar with size with the shape of esophagus abdomen section, and distal end wall part 17c be the self expandable formula and usually in shape for conical butt, thereby the shape of the nearly pars cardiaca of stomach function regulating and big or small similar.
Bariatric device 15 can comprise fixed system 21, and this fixed system can stop the far-end of this device to move.Fixed system 21 can comprise series of anchors 22, illustrates described anchor with the adnexa of the wall 117 of serial direction V-arrangement down.Selectively, described anchor can direction down barb or the shape of hook, the metal anchors of radially extending from described main body etc. exist.These arrangements provide the fixing of anti-distal migration, allow this device easily to shift out from the patient simultaneously, because described anchor provides near-end motion less resistance.In the embodiment of Fig. 1 illustrated, described anchor is placed near esophageal-gastric junction or its, for example near the distal portions 17c of wall.This location of anchor has utilized such fact, and promptly esophageal-gastric junction is thicker, thereby stronger on this position.
Bariatric device 115 comprises wall 117, wall 117 have to esophagus abdomen section apply radial pressure proximal end wall part 117a, the nearly pars cardiaca of stomach is applied the distal portions 117c of radial pressure and places the mid portion 117b (Fig. 2) of esophageal-gastric junction.For Bariatric device 15, in Bariatric device 115, mid portion 117b is by for example flaccid material 120 manufacturings of on-expansible material.In addition, distal portions 117c comprises and extends to for example enlarged 119 at its turning of the darker bottom of cardia.Flaccid material 120 comprises the ingrown opening 123 of permission material.Opening 123 to small part has defined fixed system 121.Fixed system 121 can comprise that being used for grappling Bariatric device 115 allows tissue by opening 123 ingrown second or interim element simultaneously.These second fixed systems can comprise suture, bail etc.Opening 123 can appropriately be customized so that it accepts these sutures or bail.Described suture can be soluble or undissolved.Opening 123 can lack to for example 5 openings in flaccid material part 120.Selectively, it can be the aperture dot matrix that allows tissue ingrowth.The purposes of tissue ingrowth utilize health to the reaction of Bariatric device 115 to help fixing described device, stop distal migration.Although can produce the stimulation of some mucosas when removing Bariatric device 115, this stimulation should be relatively little and recovery from illness easily.For all fixed systems described herein, fixed system 121 can with other fixed systems for example fixed system 21 grades use together.
Selectable Bariatric device 215 comprises the main body 216 (Figure 4 and 5) with expandable wall 217.Expandable wall 217 has defined the proximal part 217a, the mid portion 217b that run through wall 217 and the inner room 24 to small part of distal portions 217c.Chamber 24 can be that the single single chamber that extends to the length of wall 217 maybe can be the chamber of interconnective or separated series of separate.For example, the chamber can be located at around the close end 217a of wall 217, customizing this close end 217a makes its size and shape be fit to be positioned at patient's abdominal esophagus, with can be positioned at distal portion 217c, customizing this distal portion 217c makes its size and shape be fit to be positioned at patient's cardia, but the chamber is not present in whole or part 217b in, customize this part 27b and make its configuration size be fit to be positioned at patient's esophageal-gastric junction.Like this, wall 217 will not expanded basically at the gastroesophageal sphincter place, thereby as previously described, has reduced the interference to this sphincteral normal operation.
As seeing in Fig. 4, can be chamber 24 provides hole 25 can enter with the pin 26 that allows to insert intravital device 27 connections of patient by peritoneoscope, and this hole also is used for to chamber 24 adding fluids or from wherein removing fluid.Like this, can change or regulate the size of the radial pressure that produces by wall 217.By this mode, for example, bigger radial force can be used for the morbid obesity patient, for example surpass 40 pounds of overweight patients, and littler radial pressure can be used for the patient of overweight or slight obesity, for example 30 to 40 pounds of overweight patients.The fixed system that exists in order to the form of anchor 22 illustrates Bariatric device 25, although can use previously described other fixed systems.In addition, with respect to the device the longitudinal axis " L ", distal portions 217c can be radial symmetric maybe can be asymmetric, asymmetric be because its comprise the enlarged of previously described distal end wall part 217c.
As Fig. 5 illustrated, selectively, the reservoir 24 of Bariatric device 215 can be positioned at the intravital fluid reservoir 28 of patient and be connected and comprise controller 29, mould described controller and make it be adapted at that selectivity shifts between fluid reservoir 24 in the Bariatric device and the intravital fluid reservoir 28 of patient.Like this, the fluidic amount in the controller 29 may command fluid reservoirs 24, thus regulate by the size of the wall 217 that installs the radial force of its localized conduit generation.The optional exercisable controller 31 of patient can be provided, and this controller and internal controller 29 interconnect, and for example connect by radio frequency connector 32, change the size of the pressure that is produced by wall 217 to allow patient or medical personnel.
Controller 29 can provide the interim adjusting to the size of the radial pressure of patient's distal esophagus and/or proximal gastric that is produced by Bariatric device 215.As an example, controller 29 can comprise algorithm, the size of the radial pressure that this algorithm is produced by wall 217 in the general awake time that is increased in the patient at the fluid reservoir 24 that makes when wanting satietion fluid be transferred to device 215 from stream reservoir 30.Also can programme so that it is transferred to reservoir 30 with liquid from reservoir 24 when the expection patient will sleep and not need satietion to controller 29.Selectively, patient's controller 31 allows the radial force size of manual adjustment by wall 214 generations of device 215.For example, when patient's h.d. at night, the patient can operate customer controller 31 and with instruction control unit 29 fluid is transferred to fluid reservoir 30 from reservoir 24, thereby reduces the pressure that is produced by wall 217.When the patient woke up, the patient then can use customer controller 31 so that controller 29 increases the size of the radial pressure that is produced by wall 217.This interim control of the size of the power that is produced by wall 217 should overcome any potential tachyphylaxis, the reaction that this tachyphylaxis can make patient's neurohormonal system that the radial force generation that is produced by wall 217 is reduced gradually.Selectively, in due course, the time that can have meal according to the patient etc. is used the size of interim regulating and controlling radial force.Selectively, but the time of some hormonal readiness of controller 29 monitored patient to determine that patient's expection will be had meal, itself in addition can be to learn by oneself control system to grasp patient's change of hormone contents.
Selectable Bariatric device 315 also can comprise the limiter assembly 33 (Fig. 6) that erstricted diet is discharged from chamber 18.The form of the chamber 34 that limiter assembly 33 can extend at the intracavity of main body 316 exists.In illustrational embodiment, the distal portion 317c of limiter assembly 33 and wall 317 is adjacent, but can be in other positions of arranging along wall 317.Can use various technology for example to add or extract fluid out for example gas or liquid increase or reduce the volume of chamber 34 by blunt pin 26 (Fig. 7).Other known devices, for example external electronic device that communicates with the intravital controller (not shown) of patient and the pump/fluid reservoir size that can be used for regulating limiter assembly 33.Because this configuration, peripheral control unit can be by the internal controller primer pump to increase and to reduce the size of chamber 24.Selectively, can programme to regulate to internal controller.The cross section of chamber 28 restricted room 18.This restriction stops from the outflow in the chamber 18 of wall 16, continues dietary intake by device 318 thereby stop.This can be used for tending to continue the patient that diet surpasses satietion.
Fig. 8 for example understands selectable Bariatric device 415 with main body 416, and described main body 416 has the limiter assembly that the form with inflatable reservoir or chamber 134 exists, and described limiter assembly is around the distal portions 418a in chamber 418.Reservoir 134 provides adjustable restriction, wherein, when when chamber 134 adds extra fluid, the volumetrical increase in chamber has limited the diameter in chamber 418, regulate prevention thus from the effusive ability in the chamber of Bariatric device 418, thereby the variable restriction to food intake is provided.Chamber 134 also can increase the outer dia of device wall 417c, thereby at the cardia of patient's stomach stretch receptor has been applied extra pressure.
Selectable Bariatric device 515 can comprise the main body 516 with wall 517, and described wall comprises anti-reflux assembly 35 (Fig. 9).Anti-reflux assembly 35 can one-way valve form exist to stop anti-stream from stomach to esophagus.As best seen in Fig. 9, the form in the chamber 518 that anti-reflux assembly 35 can tubulose extends exists, and 518 expansions of described chamber can reduce anti-stream to allow the distal movement of food but shrink.
Selectable Bariatric device 615 comprises the main body 616 with wall 617, and this wall is a self expandable on proximal part 617a, middle part 617b and distal portions 617c, the latter is fashioned into patient's cardiac incisure (Figure 10).Bariatric device 615 comprises fixed system 21 in patient's esophageal-gastric junction, and for example series of anchors 22.The whole surface of wall 617 is made by the self expandable material.
Selectable Bariatric device 715 illustrated in fig. 11 has main body 716, in described main body, comes out from the intestinal that is positioned at the patient or near the discharge unit 40 of the device it from the effluent in chamber 718.This by walking around the patient basically stomach and drain into intestinal other losing weight be provided.A series of perforation 36 that device 715 can be included in discharge portion 40 will be distributing from the effluent in chamber 718 small intestinal along the patient.Use Bariatric device 715 may need dietary restrictions to collect in the chamber of elongation to avoid food.
Anchor can be placed along the diverse location of the wall appearance of device.For example, illustrate selectable Bariatric device 815 with the main body 816 with wall 817 in Figure 12, wall 817 has anchor, for example V-type appurtenance, barb or the hook that distributes along the outer wall of main body.The form that fixed system also can define the balloon expandable wall 817c of chamber 37 exists, and described balloon expandable wall imposes enough pressure to stop the distal migration of this device to the conduit that holds this device.The wall of expansible this device of air bag is to produce fixing and can exit to allow this device to be removed.Figure 13 illustrates selectable Bariatric device 815 with main body 816, and main body 816 has the wall 817 that defines chamber 818 but do not have the chamber.Other fixed systems for example suture, bail etc. can be tangible to those skilled in the art.
The selectable Bariatric device 915 of Figure 14 illustrated comprises the main body 916 with wall 917, and main body 916 is in fact by the whole gastric that places the patient.Customization wall 917 makes cardia part, the cardia of its size and shape stomach function regulating similar, and the structure wall makes it to produce the radial pressure to cardia.Device 915 comprises the fixed system 922 that connects cardia or esophageal-gastric junction.
Can use different delivery systems to send among the Bariatric device 15-915 any to the patient.This delivery system can comprise the tube (not shown), and Bariatric device is compressed in this tube.This tube can be hard or flexible pipe and the size and shape all be fit to easily be installed in patient's the esophagus.This delivery system comprises the deployment mechanism (not shown) so that Bariatric device is regained from pipe.When Bariatric device was shifted out from pipe, it presented expanded form.If use the self expandable wall, when shifting out from pipe, Bariatric device will be certainly produces radial pressure to patient's distal esophagus and/or cardia.If use distensible wall, for example air bag gives airbag aeration to produce radial pressure.Can use the wall of Bariatric device various labellings for example fluorescent labeling to allow use fluorescence when placing this device.
If can be provided for monitoring and want, regulate the degree methods 50 (Figure 15) of the satietion that produces by Bariatric device and method.In method 50, Bariatric device 15-915 is inserted the patient 52, apply level of radial pressure by the device main body wall.By for example 54 usefulness for example the hypothalamus of positron emission tomography (P.E.T.) scanning monitored patient monitor the level of satietion.P.E.T. scanning produces the hypothalamus vision figure that changes color with the amount of hypothalamus mobility.By the hypothalamic color of P.E.T. scanning, can on 56, determine whether to obtain suitable satietion level.If obtain, then carry out this method 58.
If determine not obtain suitable satietion level 56, so this process is turned back to 52, herein can be by the varying level of main body level of radial pressure.The adjusting of pressure can be by using chamber 24 to add in the Bariatric device with expandable wall or extracting fluidic form out and carry out.Selectively, the device that the adjusting of radial pressure can launch different sizes or feature carries out, described device be self expandable and by the self expandable wall patient is applied different power.Degree for different patient's satietion can be different.For example, overweight patient can need specific level of radial pressure, and fatter, for example MO patient may need higher levels of satietion.Equally, child or teenager may need the radial pressure of varying level.Acquisition to the ability of feedback immediately of satietion intensity allow to set up upon deployment system effect rather than with regard to body weight alleviate monitored patient and the patient deducted too much or very little weight after adjust it.
Can be with any is used as multidisciplinary synthesis section purpose part among the Bariatric device 15-915.This can comprise adjusts Drug therapy when patient experience loses weight.For example, for the patient who takes diabetes medicament, when alleviating, weight in patients can need insulin still less.In addition, when alleviating, weight in patients can adjust Cardura thing and other drug.
Because Bariatric device 15-915 produces the ability of satietion, in some patient, patient may need nutritional supplement for example the absorption of protein liquid take in as albumen to guarantee enough nutritional needs.In addition, can give patient's anti-nausea pill, particularly in the beginning arranging device.This is because according to the present invention, Bariatric device can produce when settling beginning feels sick.
For reduce food be captured into the chamber may with in order to make interference reduction to the natural wriggling of esophagus to minimum, make the length in chamber keep below 9cm usually.In most of embodiments, the length in chamber is in the scope of the extremely about 7cm of about 6cm.The part of the broadening of main body for example distal portion 17c-917c is not considered to be used for determine the cavity segment of cavity length.Distensible wall, no matter be self expandable or balloon expandable, should on big as far as possible area, provide consistent pressure inducing enough satietion, this and make great efforts to make the chamber to keep lacking as far as possible consistent.
Therefore, can find out that the present invention has introduced the technology that loses weight of newtype: implied satietion.The stretch receptor that the present invention advantageously uses stretch receptor for example to be positioned at the pars cardiaca of patient's esophagus abdomen section and/or esophageal-gastric junction and/or stomach causes satietion.Opposite with gastric bypass and adjustable gastric bands, the present invention does not need surgical operation.Just see on this aspect, the invention provides the invasive selection of Noninvasive or bottom line.Yet the present invention can for example gastric bypass and adjustable gastric bands be used the weight reduction with further help patient together with known restricted and/or malabsorption technology.Advantageously, the present invention can be used for the patient that avoids performing the operation, the patient who for example has the camber obesity and may have risk to operation.In addition, the present invention is used among the MO patient and obtains enough losing weight and will carry out the patient of gastric bypass with stable.In addition, the present invention be can change rightly and child and teenager made it to be applicable to.Therefore, the invention provides and be used for solving teenager and child and adult's epiphytotics Noninvasive of ever-increasing obesity or bottom line invasive technique.
The present invention also comprises the implied satietion device, the self expandable wall that this implied satietion device can be by for example suitable size or produce radial pressure by the mechanism that is used to expand outwardly described wall on patient's esophagus abdomen section, esophageal-gastric junction surface and/or cardia.This machine-processed example can be a bladder mechanism, and its mesospore can produce variable radial pressure.The present invention also has the ability of supporting to reduce esophageal leakage.This can further increase for example purposes of combination such as gastric bypass, esophageal neoplasm of the present invention and other technologies.Except influence was present in esophagus abdomen section neuro hormone feedback mechanism, originally returning bright can the prevention from the chamber of satiety device flowed out.This by suppress its surpass satietion still the ability of dietary intake extra benefit is provided for some patient.Because device can insert by the peritoneoscope that fluoroscopic assist is arranged, so described device can be rightly and accurately is positioned at patient's esophagus, esophageal-gastric junction and/or the i-card position of wanting and on request satiety device regulated.In addition, if desired, can in patient's body, take out this device subsequently.The use of various fixed systems allows described equipment to be positioned near esophagus abdomen section, esophageal-gastric junction and/or cardia or its.In addition, the use of this fixed system can make satiety device easily take out in patient's body.
By its principle being transformed into practice and finding that it causes losing weight, and can find out the evidence of vitality of the present invention in 8 patient.Never fat patient to the morbid obesity scope is settling in one or two periods in week of described device usually, and decreased average is about 7 pounds weekly.Some feeling sick when beginning of patient experience.They report satietion in the whole process that device is laid.When device no longer existed, it is hungry that the patient recovers.
Comprise what doctrine of equivalents was explained as principle, change in the embodiment that can clearly describe and variation and do not deviate from principle of the present invention, described change and change the restriction that only is subjected to the claims scope according to Patent Law.
As give a definition wherein claimed proprietary characteristic or embodiment of the present invention of privilege.

Claims (26)

1. Bariatric device, it comprises:
Main body with the wall that defines the chamber, the configuration of moulding described wall makes it similar with size with the shape that is selected from following at least a position: i) the abdomen section of esophagus; Ii) esophageal-gastric junction; Iii) the nearly pars cardiaca of stomach is transformed described wall and is made it produce radial pressure to following at least a structure: i) the abdomen section of esophagus; Ii) esophageal-gastric junction; The iii) nearly pars cardiaca of stomach, thus the neuro hormone feedback mechanism that influences the patient is with by strengthening the distension that is caused by food and stimulating distension to produce to the small part satietion under the non-existent situation of food.
2. the Bariatric device of claim 1, wherein said main body is along longitudinal axis elongation and wherein with respect to the described longitudinal axis, described main body is asymmetric in the vertical.
3. the Bariatric device of claim 2, wherein with respect to the described main body of the described longitudinal axis to small part be non-radial symmetric.
4. the Bariatric device of claim 1 wherein customizes described wall and makes its size with the nearly pars cardiaca of esophagus abdomen section, esophageal-gastric junction stomach function regulating similar with shape, and transforms described wall and make it produce radial pressure to the nearly pars cardiaca of esophagus abdomen section stomach function regulating at least.
5. the Bariatric device of claim 1, wherein said main body have parts first and second how much, and described first how much parts be cylindric, and described second how much is frusto-conical partly.
6. each Bariatric device among the claim 1-5, wherein said wall comprise and are suitable for the part that produces the self expandable part of radial pressure and be suitable for not producing the non-self expandable of radial pressure.
7. the Bariatric device of claim 6, wherein said non-self expandable partly is fit to place the gastroesophageal sphincter place.
8. each Bariatric device among the claim 1-5, wherein said wall are fit to produce constant radial pressure.
9. each Bariatric device in the claim 1 to 5, wherein said wall are fit to produce adjustable radial pressure.
10. the Bariatric device of claim 9, wherein said wall defines the chamber, and the fluidic amount in the wherein said chamber is regulated the radial pressure that is produced by described wall.
11. the Bariatric device of claim 10, it comprises the hole that external path is provided to described chamber.
12. the Bariatric device of claim 9, it comprises controller, and described controller is fit to the size of control by the radial pressure of described wall generation.
13. the Bariatric device of claim 10 or 11, it comprises controller, and described controller is fit to the size of control by the radial pressure of described wall generation.
14. the Bariatric device of claim 12, wherein said controller are fit to interim size of regulating the radial pressure that is produced by described wall.
15. each Bariatric device among the claim 1-5, it comprises at least one mechanism of ammonium fixation of the distal migration that is fit to the described main body of prevention.
16. comprising, the Bariatric device of claim 15, wherein said mechanism of ammonium fixation be selected from barb, V-type adnexa, from metal anchors, bail and suture that described main body is radially extended at least one.
17. the Bariatric device of claim 15, wherein said mechanism of ammonium fixation comprise inflatable anchor air bag.
18. the Bariatric device of claim 15, wherein said mechanism of ammonium fixation comprise at least a portion of the described main body that is fit to the promotion tissue ingrowth.
19. the Bariatric device of claim 15, wherein said mechanism of ammonium fixation is on the part of the described wall that is fit to place esophageal-gastric junction.
20. the Bariatric device of claim 16 or 17, wherein said mechanism of ammonium fixation is on the part of the described wall that is fit to place esophageal-gastric junction.
21. each Bariatric device among the claim 1-5, it comprises the effusive limiter of prevention from described chamber.
22. the Bariatric device of claim 21, wherein said limiter comprises adjustable limiter.
23. the Bariatric device of claim 22, wherein said adjustable limiter comprises fluid reservoir, and described adjustable limiter is conditioned by the fluid that changes in the described reservoir.
24. the Bariatric device of claim 23 wherein can be used for adding or shifting out enterable hole, fluidic outside from it and (b) be used for controlling a kind of in the control electronics of the fluidic amount of described reservoir and regulate described adjustable limiter to described reservoir by being selected from (a).
25. each Bariatric device among the claim 1-5, wherein said chamber has the length that is shorter than 9cm.
26. the Bariatric device of claim 25, wherein said chamber have the length in the scope between 6cm and 7cm.
CNB2005800396258A 2004-10-15 2005-10-13 Bariatric device and method Active CN100556477C (en)

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US9149383B2 (en) * 2012-01-23 2015-10-06 Apollo Endosurgery, Inc. Endolumenal esophageal restriction device
CN105266935B (en) * 2015-11-23 2017-10-13 孙思予 A kind of antireflux film omasum courage anastomosis bracket

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US6572627B2 (en) * 2001-01-08 2003-06-03 Shlomo Gabbay System to inhibit and/or control expansion of anatomical features

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