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WO2003020182A1 - Orifice de stomie a reglage electrique - Google Patents

Orifice de stomie a reglage electrique Download PDF

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Publication number
WO2003020182A1
WO2003020182A1 PCT/SE2002/001575 SE0201575W WO03020182A1 WO 2003020182 A1 WO2003020182 A1 WO 2003020182A1 SE 0201575 W SE0201575 W SE 0201575W WO 03020182 A1 WO03020182 A1 WO 03020182A1
Authority
WO
WIPO (PCT)
Prior art keywords
constriction
adjustment device
patient
stomach
oesophagus
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2002/001575
Other languages
English (en)
Inventor
Peter Forsell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Potencia Medical AG
Original Assignee
Potencia Medical AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Potencia Medical AG filed Critical Potencia Medical AG
Priority to EP02765739A priority Critical patent/EP1435882A1/fr
Publication of WO2003020182A1 publication Critical patent/WO2003020182A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/005Gastric bands
    • A61F5/0066Closing devices for gastric bands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/132Tourniquets
    • A61B17/1322Tourniquets comprising a flexible encircling member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/005Gastric bands
    • A61F5/0053Gastric bands remotely adjustable

Definitions

  • the present invention relates to an apparatus for forming a stoma opening in the stomach or oesophagus of a patient, the apparatus comprising a constriction device adapted to be applied on the patient's stomach or oesophagus and including an elongate adjustable constriction member adapted to extend around and constrict the stomach or oesophagus to form the stoma opening therein and an electrically powered adjustment device that adjusts the constriction member to change the size of the stoma opening.
  • the apparatus further comprises an electric power supply implantable in the patient remote from the constriction device, and an insulated electric wire connecting the power supply and the electrically powered adjustment device.
  • the adjustment device typically comprises an inflatable cavity in the band and an injection port in fluid connection with the inflatable cavity.
  • the injection port is subcutaneousiy implanted to allow the addition of fluid to or withdrawal of fluid from the cavity by an injection needle penetrating the patient's skin and passing into the injection port.
  • the band is made of silicone, which is a material approved for implantation, and the fluid is a liquid such as an isotonic salt solution mixed with other conventional materials.
  • a mechanical apparatus for forming a restricted stoma opening may typically involve an electrically powered adjustment device connected to the elongate constriction member. Therefore, such an adjustment device is located at the patient's stomach or oesophagus.
  • the electric power supply for example a battery, necessary for powering the adjustment device with electric energy should be implanted subcutaneousiy, i.e. remote from the adjustment device, in order to permit easy access from outside the patient's body for service or replacement of the power supply. In consequence, it is necessary to implant a fairly long electric wire for connecting the power supply to the adjustment device.
  • the kind of apparatus presented initially has also been used for treating heartburn and reflux disease due to hiatal hernia, i.e. a portion of the stomach immediately below the gastric fundus slides upwardly through the esophageal hiatus. In consequence, stomach acids and foods are regurgitated into the oesophagus.
  • An operation technique, semi-fundoduplicatio is currently in use for treating heartburn and reflux disease.
  • a most common operation is Nissen semi-fundoduplicatio, in which one takes the fundus of the stomach and makes a three quarter of a turn around the oesophagus and sutures between the stomach and oesophagus. Although this operation works fairly well it has three main disadvantages.
  • the apparatus described above when treating heartburn and reflux disease the apparatus described above may be used as an artificial cardia or sphincter, which is adjusted daily, i. e. to open and close the oesophagus.
  • the object of the present invention is to provide a new reliable electrically adjustable apparatus for forming a stoma opening in the stomach or oesophagus of a patient.
  • the electric wire is resilient and extends helically between the electric power supply and the electrically powered adjustment device.
  • the resilient helically extending electric wire is capable of addressing the dynamic movements from the stomach and oesophagus, because it may easily be temporarily extended without risking breakage.
  • the electric wire should be designed to conduct a current in the order of milliamperes, which is needed for powering the adjustment device when adjusting the constriction member, so that the constriction member exerts a force strong enough to constrict the esophagus or stomach.
  • the electric wire should have a low resistance.
  • the apparatus may include an energy transforming device capable of transforming wireless energy transmitted from outside the patient's body into electric energy, whereby the need for regularly replacing the electric power supply, when it is depleted, is eliminated.
  • the adjustment device includes an electric motor connected to the electric power supply by means of the helical electrical wire.
  • the constriction device may include a hydraulic constriction device, in which the constriction member is inflatable by hydraulic fluid, and the adjustment device may include an electrically driven pump (for example driven by the electric motor) hydraulically connected to the hydraulic constriction device.
  • the constriction member is non-inflatable and mechanically adjustable.
  • the constriction member includes a main portion and two elongated end portions, and the adjustment device establishes longitudinal relative displacement between the end portions of the constriction member, such that the size of the stoma opening is adjusted.
  • the adjustment device may include a movement transferring means in engagement with at least one of the end portions of the constriction member and operable by the electric motor to displace said one end portion relative to the other end portion of the constriction member.
  • the movement transferring means may include a gear wheel fixed to said other end portion of the constriction member and a gear rack formed on said one end portion of the constriction member, the gear wheel and the gear rack being in mesh with each other.
  • the adjustment device may further include a worm gear connected between the electric motor and the gear wheel.
  • the constriction device includes a housing containing the adjustment device, and the elongate constriction member and the housing are adapted to form a loop around the patient's stomach or oesophagus.
  • the apparatus includes a control device, suitably in the form of a wireless remote control, for controlling the adjustment device to adjust the constriction device to change the size of the stoma opening.
  • the control device may include an internal, preferably programmable, control unit implantable in the patient for controlling the adjustment device.
  • the control device may include an external control unit outside the patient's body, wherein the internal control unit is programmable by the external control unit.
  • the apparatus may include at least one implantable sensor for sensing at least one physical parameter of the patient.
  • the sensor may be a pressure sensor for directly or indirectly sensing the pressure against the constriction member.
  • the control device may suitably control the adjustment device in response to signals from the sensor. Where the control device includes an internal control unit, the internal control unit may control the adjustment device in response to signals from the sensor.
  • the apparatus may include a switch implantable in the patient for directly or indirectly switching the electric energy supplied by the electric power supply.
  • Figure 1 is a schematic view of an apparatus according to the present invention implanted in an obese patient
  • Figure 2 schematically illustrates an embodiment of a constriction device of the apparatus used in the apparatus of Figure 1.
  • Figure 1 shows an apparatus of the present invention for forming a stoma opening in the stomach 1 of an obese patient comprising a constriction device 2 applied on the stomach 1.
  • the constriction device 2 includes an elongate adjustable constriction member 3 extending in a loop around and constricting the stomach 1 to form an upper pouch 4 of the stomach 1 and a restricted stoma opening in the stomach 1.
  • An electrically powered adjustment device 5 that adjusts the constriction member 3 to change the size of the stoma opening is housed in an elongate housing 6, see Figure 2.
  • the constriction member 3 has a first end portion 9 releasably connected to the housing 6 and a second end portion 10 connected to the adjustment device 5.
  • the adjustment device 5 includes an electric motor 7 and a movement transferring means 8 in engagement with the end portion 10.
  • the electric motor 7 operates the movement transferring means 8 to displace the end portion 10 relative to portion 9 in the loop formed by the constriction member 3.
  • the movement transferring means 8 includes a gear wheel 11 fixed to the housing 6, a worm gear 12 connected between the electric motor 7 and the gear wheel 11, and a gear rack 13 formed on the end portion 10, wherein the gearwheel 11 and the gear rack 13 are in mesh with each other.
  • a rechargeable electric power supply 14 is subcutaneousiy implanted in the patient and fixed to the breastbone 15 (the sternum).
  • An external remote control 16 controls the adjustment device 5 and transmits signals that are received by a combined control and energy transforming unit 17 subcutaneousiy implanted in the patient.
  • the unit 17 is electrically connected to the electric power supply 14 and transforms the energy of the signals into an electric current that is used for charging the electric power supply 14.
  • the signals may include electromagnetic waves and the unit 17 may include an electric p-n junction element that transforms the wireless energy into an electric current.
  • a resilient insulated electric wire 18 connects the power supply 14 and the electric motor 7.
  • the electric wire 18 extends helically between the power supply 14 and housing 5 that contains the motor 7, in order to permit the electric wire 18 to be temporarily extended when dynamic movements of the stomach and oesophagus occur, so that the risk of breaking the electric wire 18 is eliminated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Surgery (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Prostheses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un appareil permettant de former un orifice de stomie dans l'estomac (1) ou l'oesophage d'un patient. Cet appareil comprend un dispositif d'étranglement (2) appliqué sur l'estomac ou l'oesophage du patient et comportant un élément d'étranglement allongé ajustable s'étendant autour de l'estomac ou de l'oesophage et réalisant un étranglement pour y former l'orifice de stomie, et un dispositif alimenté en énergie électrique qui règle l'élément d'étranglement pour changer la taille de l'orifice de stomie. Un bloc d'alimentation électrique (14) est implanté sous-cutané chez le patient à une certaine distance du dispositif d'étranglement et un fil électrique isolé (18) relie le bloc d'alimentation électrique et le dispositif de réglage alimenté en énergie électrique. Le fil électrique est élastique et s'étend en hélice entre le bloc d'alimentation en énergie électrique et le dispositif de réglage alimenté en énergie électrique. Par conséquent, le fil électrique (18) élastique s'étendant en hélice est capable d'adresser les mouvements dynamiques de l'estomac et de l'oesophage car il peut facilement s'étendre temporairement sans risque de rupture.
PCT/SE2002/001575 2001-09-06 2002-09-04 Orifice de stomie a reglage electrique Ceased WO2003020182A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP02765739A EP1435882A1 (fr) 2001-09-06 2002-09-04 Orifice de stomie a reglage electrique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US31716401P 2001-09-06 2001-09-06
US60/317,164 2001-09-06

Publications (1)

Publication Number Publication Date
WO2003020182A1 true WO2003020182A1 (fr) 2003-03-13

Family

ID=23232394

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2002/001575 Ceased WO2003020182A1 (fr) 2001-09-06 2002-09-04 Orifice de stomie a reglage electrique

Country Status (2)

Country Link
EP (1) EP1435882A1 (fr)
WO (1) WO2003020182A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006107901A1 (fr) * 2005-04-04 2006-10-12 Micardia Corporation Renforcement dynamique du sphincter oesophagien inferieur
US20110230961A1 (en) * 2010-01-05 2011-09-22 Micardia Corporation Dynamically adjustable annuloplasty ring and papillary muscle repositioning suture
US8870742B2 (en) 2006-04-06 2014-10-28 Ethicon Endo-Surgery, Inc. GUI for an implantable restriction device and a data logger
US20240082035A1 (en) * 2008-10-10 2024-03-14 Peter Forsell Device, system and method for treating obesity

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001047575A2 (fr) * 2000-02-11 2001-07-05 Obtech Medical Ag Appareil restreignant l'absorption de nourriture avec application d'energie sans fil commandee
WO2001049245A2 (fr) * 2000-02-10 2001-07-12 Obtech Medical Ag Appareil destine a traiter les aigreurs et les reflux

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4000745A (en) * 1968-08-05 1977-01-04 Goldberg Edward M Electrical leads for cardiac stimulators and related methods and means
US5935465A (en) * 1996-11-05 1999-08-10 Intermedics Inc. Method of making implantable lead including laser wire stripping
US6235990B1 (en) * 1998-08-17 2001-05-22 Telephone Products, Inc. Modular retractile telephone cords

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049245A2 (fr) * 2000-02-10 2001-07-12 Obtech Medical Ag Appareil destine a traiter les aigreurs et les reflux
WO2001047575A2 (fr) * 2000-02-11 2001-07-05 Obtech Medical Ag Appareil restreignant l'absorption de nourriture avec application d'energie sans fil commandee

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006107901A1 (fr) * 2005-04-04 2006-10-12 Micardia Corporation Renforcement dynamique du sphincter oesophagien inferieur
US8870742B2 (en) 2006-04-06 2014-10-28 Ethicon Endo-Surgery, Inc. GUI for an implantable restriction device and a data logger
US20240082035A1 (en) * 2008-10-10 2024-03-14 Peter Forsell Device, system and method for treating obesity
US20110230961A1 (en) * 2010-01-05 2011-09-22 Micardia Corporation Dynamically adjustable annuloplasty ring and papillary muscle repositioning suture

Also Published As

Publication number Publication date
EP1435882A1 (fr) 2004-07-14

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