Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/005—Gastric bands
  • A61F5/0053—Gastric bands remotely adjustable
  • A61F5/0059—Gastric bands remotely adjustable with wireless means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/135—Tourniquets inflatable
  • A61B17/1355—Automated control means therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/005—Gastric bands
  • A61F5/0053—Gastric bands remotely adjustable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00212—Electrical control of surgical instruments using remote controls
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F2005/0016—Implantable devices or invasive measures comprising measuring means

Definitions

• the invention relates to a system for controlling a controllable gastric band, comprising a control unit, wherein the gastric band comprises a non-distensible back and a stoma side of the back arranged with a fluid-fillable chamber which communicates with a second chamber, and at least one sensor for detecting the Pressure on the stomach wall, and the sensor is connected to a device for wireless transmission of the detected pressure values to the control unit, and the control unit comprises means for receiving the transmitted pressure data of the at least one sensor of the gastric band and a housing.
• Controllable gastric bands in which a supply of liquid into the chamber or emptying of liquid from the chamber by piercing a subcutaneously fixed chamber, a so-called port, which is connected to the chamber of the gastric band via a corresponding line, is achieved by numerous companies in principle of the same design offered.
• a gastric band is a medical implant used to restrict food intake and thus to reduce weight, which is wrapped and closed around the uppermost part of the stomach.
• US Pat. No. 6,966,875 B1 describes a gastric band which is wrapped around the stomach in a belt-shaped manner and fastened. An adjustment of the constriction of the stoma is possible purely mechanically by narrowing the band.
• US Pat. No. 4,592,339 A describes a gastric band in which a chamber is arranged on the side of the band facing the stomach which can be filled with liquid. This allows the control of the stoma size. Through a subcutaneously sewn port, which is connected via a tube with the chamber of the gastric band, a liquid filling and emptying of the system can be performed.
• WO 2004/014245 A1 describes a controllable gastric band, wherein the displacement of the liquid from a port into the chamber mer of the gastric band remotely controlled from the outside can be made.
• WO 2005/009305 Al relates to a controllable gastric band, in the problems mentioned above are to be overcome by an autoregulative change in the size of the territory. They are based on the changes in ligament pressure associated with peristalsis of the esophagus during a meal. The bolus is pushed through peristaltic waves through the gastric band. This causes a rise in pressure in the chamber of the gastric band, which can be used to regulate the pressure of the gastric band.
• WO 01/12078 A1 shows a control system of the type in question, wherein the pressure values on the stomach wall are detected and transmitted to a control unit. When exceeding or falling below predefined values of the pressure, a corresponding change in the gastric band filling occurs. However, the current pressures on the gastric wall are not suitable for immediate adjustment of the gastric band width.
• No. 6,475,136 B1 describes a controllable gastric band in which an implanted pressure sensor determines the pressure on the stomach wall and uses it to regulate the band adjustment.
• X-ray examinations are also carried out after the administration of a contrast agent, which proceeds much faster than the in vivo measurement of the internal band pressure.
• these measurements are burdensome for the patient due to the X-rays and also very expensive.
• the object of the present invention is therefore to provide an abovementioned system for controlling a tax system. gastric ligament with which a simple and for the patient little stressful monitoring of the pressure in the gastric band is possible.
• the present invention is intended to remedy or reduce the problems previously encountered in gastric bands without autoregulative function.
• the object according to the invention is achieved by providing at least one memory for storing the determined pressure values and a device for processing the temporal profiles of the received pressure values.
• a system makes it possible to detect the pressure on the stomach wall during certain events, preferably during the meal or continuously, and to transmit it wirelessly to a control unit.
• the transmission of the detected pressure values can take place permanently or a specific number of data can be temporarily stored and transmitted wirelessly on request to a control unit.
• the patient does not have to go to outpatient treatment to record the pressure, but the important data is collected during the normal daily routine or even at night.
• the problems of currently used gastric bands without autoregulative function can be eliminated.
• the pressure with which the gastric band or the fluid-filled chamber presses against the stomach plays a key role in so-called gastric banding.
• the in-band pressures reflect the extent of drainage obstruction and in particular the retroactive effect of obstruction on esophageal motor function.
• the values can be buffered and transmitted on request for evaluation.
• Such a memory can also serve for buffering the pressure values in the event of a malfunction, so that no important information is lost. The results provide the patient or the attending physician or the like with important information.
• the system according to the invention achieves a control of physiological parameters which are of importance in connection with "gastric banding."
• the control system allows a simple monitoring of the motor function of the esophagus which is less stressful for the patient to pressure increases in the GENBAND.
• the peristaltic wave carries the bite through the band into the stomach. In the Stomapassage it comes to the mentioned pressure increase in the band system.
• the amplitude of the pressure increase in the gastric band depends on the amplitude of the peristaltic wave, the extent of the flow obstruction and the viscosity of the bite.
• the doctor can go to the limit of compatibility in the Bandeng ein and thus achieve the maximum therapy effect without compromising the motor activity of the esophagus to accept.
• pressure monitoring an optimal gastric band adjustment but also a self-control of the patient regarding the eating behavior can be achieved.
• the transmission device is preferably formed by a high-frequency transmitter and the receiving device by a high-frequency receiver.
• the performance of the co-implanted radio frequency transmitter is relatively low for achieving relatively low ranges, whereby the power consumption is also minimal and thus the lifetime of the implant is increased.
• the high-frequency transmitter by a passive transmitter and inductively couple the energy necessary for the transmission of the detected pressure values from the outside into the system.
• passive systems are already known in other implants.
• the transmission device in the gastric band and the receiving device in the control unit can be formed by a radio-frequency transponder, which performs both transmitting and receiving functions.
• At least one pressure sensor is formed by a piezoelectric sensor.
• the sensor can be arranged at any point in the gastric band, which is suitable for measuring the pressure acting on the stomach wall, that is, for example, in the chamber or on the chamber side disposed on the chamber side or the like.
• a memory for storing the determined pressure values in the gastric band, the values can be buffered and, if requested to the control unit, transmitted for evaluation.
• a memory in the gastric band can also be used for temporarily storing the pressure values in the event of a malfunction of the control unit, so that no important information is lost.
• a memory for storing the determined data on the one hand and any calculation formulas or programs on the other hand may be provided in the control unit.
• a display is preferably provided in the control unit, via which the data or data derived therefrom can be transmitted to the patient.
• the display may consist of simple light sources, via which certain states are visually displayed, or also by numeric displays for displaying the pressure values or values derived therefrom, up to screens via which the course of the pressure over time can be displayed graphically.
• the device for processing the received pressure values is preferably formed by a microprocessor.
• a time module can be provided in the control unit, as is usually the case with microprocessor applications.
• at least one operating element can be provided in the control unit.
• a signal generator may be provided in the control unit.
• Such a signal generator may be formed, for example, by a loudspeaker or a vibration generator.
• the latter has the advantage that, similar to the vibration of a mobile phone, the environment is not made aware of the signal from the signal generator.
• control unit preferably has an interface for transferring the data to, for example, a computer or the like.
• the patient transmits the data for evaluation to the clinic or the attending physician, for example via the Internet or the telephone network and not for a report to the clinic or the attending physician.
• the housing of the control unit is formed in the form of a wristwatch with a corresponding watch band.
• the patient with the implanted gastric band can constantly carry the control unit in a comfortable manner and is thus constantly informed about the condition of the gastric band.
• the data can be stored over a certain period of time, for example 24 hours, and thereafter the control unit can be transmitted to an evaluation device, for example the attending physician, where an analysis of the data takes place.
• a device for introducing or extracting the fluid into or out of the chamber of the gastric band can be provided so that the pressure in the chamber of the gastric band can be optimized on the basis of the detected and evaluated pressure values.
• an automatic or semi-automatic system can be created, which due to the detected pressure values the - Q -
• the device for introducing or extracting the fluid into or out of the chamber can likewise be formed by an implant, which receives the corresponding information wirelessly from the control unit.
• the means for introducing or extracting the fluid may be formed by a pump arranged in the connection between the chamber and the second chamber of the gastric band, which pump can convey the fluid from the chamber into the second chamber or vice versa.
• a sensor for measuring the swallowing activity which sensor is connected to a device for the wireless transmission of the detected sensor values to the control unit.
• a sip sensor may be formed, for example, by a microphone or a pressure transducer affixed to the neck of the patient.
• a line is provided for connecting the control unit to a communication device, in particular a computer or a telephone.
• a communication device in particular a computer or a telephone.
• the second chamber of the gastric band is usually formed in the subject gastric bands without autoregulative function, usually by a subcutaneous port to be placed, via which by means of a hypodermic the fluid can be introduced into the chamber of the gastric band or sucked out of it.
• the two chambers of the controllable gastric band or the chamber and the port are preferably connected to one another via a line, wherein at least one device for controlling the flow of the fluid can be arranged in the line.
• The- The flow control device may for example be formed by a valve or a pump, whereby an automatic regulation of the pressure in the chamber of the gastric band and thus on the stomach wall is made possible on the basis of the measured pressure values.
• the processing device is designed to determine the duration and speed of an eating process. Based on the determined parameters of the eating process, an optimization of the band setting by the doctor or can be done automatically or the patient important information about his eating behavior can be delivered.
• the processing device is preferably designed for evaluating the amplitude and duration of the determined pressure values during an eating process.
• the amplitude and duration of increases in pressure are important indicators of excessive esophageal load.
• the object according to the invention is also achieved by a method for controlling an implanted gastric band with a fluid-filled chamber, wherein the pressure on the stomach wall is measured and the amount of fluid in the chamber of the gastric band is adjusted on the basis of the determined pressure, the pressure values being continuous be measured and from the measured pressure values, the duration and the speed of a meal process is determined. Based on the determined parameters over the eating process, an optimization of the band setting by the doctor or automatically done or the patient important information about its eating behavior can be delivered.
• the amplitude and duration of the increases in the pressure values during a meal are evaluated for a conclusion on a change in the motor performance of the esophagus.
• the amplitude and duration of increases in pressure are important indicators of excessive esophageal load.
• the Adjustment of the fluid pressure in the chamber of the gastric band can be optimized accordingly.
• Fig. 1 is a schematic representation of a control system consisting of the gastric band with the sensor and the control unit;
• Figure 2 is a schematic representation of an implanted gastric band according to the invention with a control unit in the form of a wristwatch.
• FIG. 3 shows a schematic representation of the data transmission from a control unit, for example to a computer
• Figure 4 shows the time course of the detected pressure in the gastric band during several swallowing operations at different fillings of the chamber of the gastric band.
• Fig. 5 shows the time course of the pressure in the gastric band during a meal.
• Fig. 1 shows schematically a gastric band 1 together with a control unit 11, by means of which the pressure of the gastric band 1 can be monitored.
• the gastric band 1 has a non-stretchable back 4.
• On the side of the back 4 facing the stomach wall 3 there is at least one chamber 2 which can be filled with a liquid or a fluid.
• the chamber 2 is connected to a second chamber 5 via a line 6.
• the second chamber 5 can be designed as a so-called port arranged subcutaneously in the lower abdomen (see FIG.
• a corresponding device 10 for controlling the flow of the liquid can also be provided in the connecting line 6.
• This control device 10 may be formed for example by a valve or a pump be (not shown).
• at least one sensor 7 is provided for measuring the pressure acting on the stomach wall 3 or a variable proportional thereto, which sensor 7 is provided with a device 8 for wireless transmission of the detected pressure values to a control unit 11 is connected.
• a memory 9 For storing or temporarily storing the pressure values detected by the pressure sensor 7, a memory 9 may be provided.
• the implanted transmission device 8 can be powered by a battery with electrical energy, or be constructed completely passive, the energy required for the transmission of data from the outside, in particular from the receiver of the control unit 11, would be introduced.
• the transmission device 8 may also be formed by a transponder.
• the control unit 11 includes a device 13 for receiving the transmitted pressure data of the sensor 7 of the gastric band 1, which may also be designed as a transponder.
• a display 15 is preferably arranged in the housing 12 of the control unit 11. Via a device 16, the received pressure values are processed.
• This processing device 16 is preferably by a microprocessor, microcontroller or the like. educated. In order to be able to allocate the recorded and transmitted data temporally, a time module can be used
• a signal generator for example a loudspeaker 20 or a vibration generator 21 may be provided.
• the components of the control unit 11 are supplied with electrical energy by a voltage supply 19, which is preferably formed by a rechargeable battery.
• a voltage supply 19 which is preferably formed by a rechargeable battery.
• an interface 22 may be provided. Via such an interface 22, data can also be written to the processing device 16 or into the memory 14.
• the interface 22 may be formed, for example, by various standardized interfaces. Both wired and wireless (eg infrared or radio frequency) interfaces are used.
• Fig. 2 shows schematically an application of the gastric band 1 according to the invention with at least one pressure sensor 7, wherein the second chamber 5 is formed by a so-called subcutaneous port, which is connected to the chamber 2 of the gastric band 1 via a conduit 6, in which, for example a pump 25 may be arranged which controls the liquid transport from the chamber 2 to the chamber 5 or vice versa.
• the gastric band 1 surrounds the entrance of the stomach M of the patient P.
• the data of the pressure sensor 7 are transmitted to the control unit 11, which in the example illustrated is in the form of a wristwatch with a corresponding watchband (see FIG they are processed and stored or displayed.
• a sensor 26 for measuring the swallowing activity of the patient P can be connected to a corresponding device 27 for wireless transmission and these data can also be transmitted wirelessly to the control unit 11.
• the control unit 11 serves as a biofeedback instrument, which reflects its eating behavior. In addition to the duration of food intake, other factors, such as the rate of food intake and the extent of chewing, can be identified and displayed. A large eating speed as well as bad chewing leads to higher pressure increases in the gastric band. This makes pressure monitoring for the patient an instrument of self-control regarding eating behavior. In addition, system malfunctions, e.g. be immediately recognized by fluid loss due to leakage of the gastric band 1 and the patient P be reported back.
• the control unit 11 prepares the print data in a form readily comprehensible to the patient and gives him immediate feedback regarding his eating behavior as well as warnings in case of improper functioning of the gastric band 1 as well as signs of muscular exhaustion of the esophagus. He is then advised of the need for immediate medical supervision.
• the feedback to the patient P can be transmitted via visual information on a display 15 or by acoustic or tactile signal transmitters (see Fig. 1).
• FIG. 3 schematically shows a block diagram of the remote data transmission from the control unit 11, for example to a computer 31.
• the control unit 11 preferably via the interface 22 (see FIG. 1), is connected to a corresponding line 28 having a communication device, for example, a computer 29 connected.
• a communication device for example, a computer 29 connected.
• the data contained in the control unit 11 can be transmitted to the computer 29 and from this via a data network 30, in particular the Internet, to another computer 31.
• the patient can transfer the data of his control unit 11 in a convenient and time-saving manner to a computer 31 of the clinic or the attending physician, where they are evaluated accordingly.
• the optimization of the band adjustment is an important point to On the one hand to achieve maximum therapeutic success, and on the other hand to prevent damage to the esophagus by a too long residence of food in the esophagus (see above).
• the retention of portions of the esophagus in the esophagus stimulates the appearance of secondary peristaltic waves. This secondary peristalsis attempts to transport the bolus and cleanse the esophagus. If this does not succeed and food remains are constantly above the gastric band, this leads on the one hand to mucous membrane inflammation with corresponding pain over the course of days and weeks, on the other hand to a motor exhaustion and increasing expansion of the esophagus.
• Fig. 4 shows the time course of the pressure in the gastric band during several swallowing of 15 ml of water at three different band fillings, namely 6 ml, 6.5 ml and 7 ml.
• This time-pressure diagram shows the dependence of the secondary peristalsis on the extent of bottlenecking the band and thus the drainage obstruction.
• Each time the tape is filled the patient has to take a 15 ml water sip (arrow A).
• At 6 ml band filling shows only a single increase in pressure in the gastric band. This pressure increase corresponds to the primary peristaltic wave triggered by the act of swallowing (arrow B).
• the primary peristaltic wave is followed by five secondary peristaltic waves (area C) (not triggered by a swallow). This points to the already very pronounced outflow obstruction. With 7 ml filling volume, the tape is no longer consistent. This is expressed in the continued secondary peristalsis (area C) following the 15 ml water swallow.
• the optimum band filling in this case is in the range between 6 and 6.5 ml.
• Fig. 5 shows the time course of the detected pressure in a gastric band during a meal composed of soup and dill potatoes.
• the subject begins to eat the soup, at time t 2 with the meal of the potato.
• the arrow labeled t3 marks the end of the meal.
• the pressure waves derived inside the band reflect the duration of the meal. After the end of the meal, depending on the degree of flow restriction in the interior of the band, pressure waves can still be dissipated for a different time.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Vascular Medicine (AREA)
• Public Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Obesity (AREA)
• Nursing (AREA)
• Surgery (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Child & Adolescent Psychology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Molecular Biology (AREA)
• Computer Networks & Wireless Communication (AREA)
• Medical Informatics (AREA)
• Reproductive Health (AREA)
• Hematology (AREA)
• Biophysics (AREA)
• Surgical Instruments (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

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Cited By (11)

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• 2005
  • 2005-12-22 AT AT0205805A patent/AT502985B1/de not_active IP Right Cessation
• 2006
  • 2006-12-21 RU RU2008130100/14A patent/RU2442549C2/ru not_active IP Right Cessation
  • 2006-12-21 JP JP2008546021A patent/JP2009520517A/ja active Pending
  • 2006-12-21 WO PCT/AT2006/000529 patent/WO2007070906A2/de not_active Ceased
  • 2006-12-21 AT AT10164256T patent/ATE550001T1/de active
  • 2006-12-21 EP EP10164256A patent/EP2218427B1/de not_active Not-in-force
  • 2006-12-21 ES ES06817495T patent/ES2398534T3/es active Active
  • 2006-12-21 CN CN2006800483941A patent/CN101340868B/zh not_active Expired - Fee Related
  • 2006-12-21 US US12/085,538 patent/US8622888B2/en not_active Expired - Fee Related
  • 2006-12-21 EP EP06817495A patent/EP1962742B1/de not_active Not-in-force

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