WO2012089881A1 - Dispositif d'introduction gastrique - Google Patents

Dispositif d'introduction gastrique Download PDF

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Publication number
WO2012089881A1
WO2012089881A1 PCT/ES2011/070868 ES2011070868W WO2012089881A1 WO 2012089881 A1 WO2012089881 A1 WO 2012089881A1 ES 2011070868 W ES2011070868 W ES 2011070868W WO 2012089881 A1 WO2012089881 A1 WO 2012089881A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
guide tube
distal end
tube
introducer device
Prior art date
Application number
PCT/ES2011/070868
Other languages
English (en)
Spanish (es)
Inventor
Ramón ABAD BELANDO
Original Assignee
Abad Belando Ramon
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 Abad Belando Ramon filed Critical Abad Belando Ramon
Publication of WO2012089881A1 publication Critical patent/WO2012089881A1/fr

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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
    • A61F5/003—Implantable devices or invasive measures inflatable
    • 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
    • A61F5/0036—Intragastrical devices
    • A61F5/004—Intragastrical devices remotely adjustable
    • 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
    • A61F5/0089—Instruments for placement or removal

Definitions

  • the present invention refers to a gastric introducer device used for the treatment of obesity.
  • the present invention refers to a device comprising an inflatable balloon that is temporarily implanted in the stomach of obese patients and that helps achieve significant weight loss in a short period of time.
  • Said treatment comprises the use of a deflated inflatable balloon attached to the distal end of a balloon or feeding tube of the balloon that is blindly inserted through the patient's oral route and that passes through the esophageal route until it reaches the stomach.
  • the balloon inflation tube has to be long enough so that the proximal end of said inflation tube is arranged outside the patient.
  • a syringe is inserted through the orifice of the proximal end of said swelling tube that protrudes from the patient's mouth and a liquid or air is introduced that swells the balloon into the stomach.
  • the swelling tube is pulled outward causing the distal end of said tube with the balloon and automatic closure of the balloon by means of a unidirectional liquid inlet valve. Subsequently, said swelling tube is removed from inside the patient.
  • the process of placing the balloon is done by touch and blindly without being able to monitor where the balloon is connected to the inflation tube. In some cases, this technique has led to incorrect insertion of the balloon, often causing tracheal injuries. In some cases, in order to avoid the insertion of the balloon through the tracheal route, the patient was previously intuited through the tracheal route of said patient in order to have the airway secured and then the balloon attached to the swelling tube is inserted. However, the use of a respiratory probe, in addition to being annoying and requiring additional control to the control necessary for the insertion of said ball, does not ensure a correct insertion of the ball avoiding injuries.
  • the union of the distal end of the swelling tube with the balloon is a weak joint that facilitates the process of disunity once the balloon is inside the stomach. Any complication during the process of inserting the assembly formed by said inflation tube attached to said balloon that requires an urgent withdrawal of said assembly, could cause an early disunity of the distal end of said tube with the balloon, leaving the balloon released anywhere between the stomach and mouth of the patient.
  • Document US4485805 discloses a balloon insertion device comprising a balloon attached to a balloon inflation tube and a guide tube which comprises inside a nylon filament whose distal end is attached to said balloon, so that said guide tube allows the balloon to be guided to a patient's stomach.
  • this device does not allow to ensure the correct insertion of the guide tube that also requires a touch and blind placement process. Additionally, this document does not prevent the ball from being released before reaching the stomach.
  • a gastric balloon introducer device that allows to solve the aforementioned drawbacks. More particularly, it is an objective of the present invention to disclose a gastric balloon introducer device that ensures the correct insertion of the gastric balloon into the stomach, without erroneous insertions by tracheal route and without causing any type of injury. According to the present invention, this is achieved by a gastric balloon introducer device of the type comprising:
  • a guide tube comprising a distal end and a proximal end and comprising a through hole between said distal and proximal ends;
  • a balloon inflation tube defining a distal end and a proximal end
  • said inflatable balloon is connected by an end portion to the distal end of said swelling tube, characterized in that said device further comprises a filiform preguiding filament, comprising a distal end and a proximal end, adapted to be introduced by said hole through said guide tube and whose distal end is free, without any connection to said guide tube, said inflation tube or said balloon.
  • Said filament is previously introduced by the esophageal route to the stomach so as to guide said guide tube to the stomach.
  • said preguiding filament has a length greater than said guide tube.
  • distal end of said preguiding filament is free, without any attachment to said guide tube, said inflation tube or said balloon, since said distal end is the part of the preguided filament that first reaches the stomach.
  • the distal end of said preguiding filament is more flexible than the proximal end of said preguiding filament, in this way a better insertion of the filament through the esophageal route to the stomach is achieved avoiding damaging the walls of said esophageal route.
  • said guide tube and said inflation tube are joined in parallel and adjacent position by at least one first connecting element. More preferably, said first joint element wraps part of the surfaces of said guide tube and said swelling tube in contact. In this way, we managed to optimize the process of inserting the device by inserting the guide and the swelling tube at the same time.
  • said preferably deflated balloon is directly connected to said guide tube by at least a second connecting element.
  • the distal end of said guide has a conical shape.
  • the conical shape of said end allows a more optimal insertion of the gastric introducer device allowing esophageal dilation.
  • an end portion of said balloon opposite said portion attached to the distal end of said inflation tube makes contact with the distal end of said guide.
  • the balloon arranged next to the distal end of said guide it allows to ensure the placement of said balloon in the stomach once the distal end of said guide has reached the stomach.
  • said second connecting element involves part of said balloon and part of the surface of said guide tube. More preferably, said second connecting element wraps the distal end conically finished of said guide tube and an end portion of said balloon. This union allows to give a more conical shape to said union making possible a more optimal insertion of the gastric introducer device through the esophageal pathway of the patient.
  • said balloon is wrapped by a wrap.
  • said wrapper that surrounds said balloon is directly attached to said guide tube by at least a second connecting element. More preferably, said second joint element wraps part of said envelope and part of the surface of said guide tube in contact with said envelope.
  • said second connecting element is breakable.
  • the joint between the proximal end of said inflation tube and said balloon is separable.
  • said balloon comprises a self-return valve.
  • said guide and said inflation tube are flexible elastic type.
  • Figure 1 shows a perspective view of a gastric balloon introducer device according to the present invention.
  • Figure 2 shows an enlarged perspective view of a part of the gastric balloon introducer device according to the present invention.
  • Figures 3 to 10 show different perspective views of a method of using the gastric balloon introducer device according to the present invention.
  • Figure 1 shows an embodiment of the invention of a device -1- gastric balloon introducer comprising a guide tube -2- such as, for example, a semi-flexible probe of PVC plastic or other similar material.
  • Said guide tube -2- comprises a distal end -22- and a proximal end -21-.
  • said guide tube -2- comprises a through hole between said distal ends -22- and proximal -21- adapted to comprise inside said through hole a pre-guided filament -4- filiform, such that said guide tube - 2- can carry out translation movements with respect to said preguiding filament -4-.
  • Said filament -4- is introduced into the through hole of said guide tube -2- through the distal end -22- and protrudes through the proximal end -21- thereof.
  • Said filament -4- comprises a diameter, approximately 4-5 mm, equal to the internal diameter of the through hole of said guide tube -2-, so that a position of said guide tube -2- can be maintained with respect to said filament -4-.
  • the length of the filament -4- approximately 3-4 m, is greater than the length of the guide tube -2-, approximately 100 cm.
  • Said device -1- gastric balloon introducer also comprises a tube -3- of flexible type adapted for the inflation of an inflatable balloon -5-.
  • Said tube -3- comprises a proximal end -31- through which an irrigating element -6- such as a syringe and a distal end -32- is connected which is coupled to an end part of said inflatable balloon -5- which It is previously deflated.
  • Said guide tube -2- and inflation tube -3- are connected in parallel and adjacent to each other by means of at least one connecting element -7-.
  • Said connecting element -7- is of the envelope type such as for example a plastic tape or other similar material that wraps part of the surfaces of said guide tube -2- and swelling tube -3- in contact.
  • said deflated balloon -5- that is attached to the distal end -32- of said tube -3- is also attached to a part of said guide tube -2- by at least one connecting element -8-.
  • Said connecting element -8- is also of the envelope type so that it can wrap part of the surface of the balloon -5- and part of the distal end -22- of said guide tube -2-.
  • said connecting element -8- is of the breakable type so that as the balloon swells inside the stomach, said connecting element -8- yields until it breaks leaving the balloon -5- free of its union with said guide tube -2-.
  • Figure 2 shows an enlarged view of the set of main elements that form the device -1- gastric balloon introducer.
  • the conical shape of the distal end -22- of said guide tube -2- can be observed. Said conical shape helps to expand the esophageal pathway during insertion of said device -1- through filament -4-.
  • at least one connecting element -8- wraps the end portion -51- of said deflated balloon -5- with a part of said distal end -22- of said guide tube -2-.
  • Preferably, only one connecting element -8- wraps the distal end -51- of the deflated balloon -5- with the distal end -22- of the guide tube -2-.
  • an endoscopic apparatus comprising a proximal end and a distal end, is introduced through the patient's mouth until reaching the stomach -100- so that the distal end of said endoscopic apparatus is disposed within the stomach -100- and the proximal end thereof is outside the patient's mouth.
  • Said endoscopic apparatus allows to verify that there is no counterproductive anomaly.
  • Said endoscopic apparatus may comprise at least one channel through which said preguiding filament -4- is introduced until reaching the stomach -100-, so as to obtain the distal end -42- of said preguiding filament -4- within the stomach - 100- and the proximal end -41- thereof outside the patient.
  • the endoscopic apparatus serves as a guide for said preguiding element -4- to the stomach -100-, ensuring correct insertion.
  • the end part that ends at the distal end -42- of said preguiding filament -4- is more flexible than the opposite end part that ends at the proximal end -41- thereof. Therefore, since the distal end -42- of said preguiding filament -4- is the end that is inserted first through the channel of the endoscopic apparatus, it is necessary for said distal end -42- to have one more degree high flexibility to adapt to the curvatures from the pharynx -101-, passing through the esophageal route -102- until reaching the stomach -100-.
  • the endoscopic apparatus is removed leaving the preguided filament -4- with the proximal end -41- on the outside of the patient and the distal end -42- inside the stomach -100-, as shown in Figure 3
  • said preguiding filament -4- must be of a suitable soft material such as, for example, nititol to avoid damaging the esophageal and stomach mucus.
  • the assembly preferably formed by the union of said guide tube -2- and said balloon inflation tube -3- is inserted by matching the distal end -22- of the guide tube -2- with the proximal end -41- of the preguiding filament -4- that is outside the patient.
  • said assembly formed by the union of said guide tube -2- and said balloon inflation tube -3- slides towards the pharynx -101-, the esophagus -102- and finally the stomach -100- of the patient allowing the entrance of the preguiding filament -4- through the through hole of said guide tube -2-.
  • the esophageal route -102- may be slightly closed, so it is necessary to help expand said route -102- by means of the assembly formed by the union of said guide tube -2- and said tube of bloated -3-. That is why the distal end -22- of said guide tube -2- has a conical shape. Additionally, being the distal end -51- of the deflated balloon -5- adhered to the distal end -22- of said guide tube, allows said joint to take an approximately conical shape to facilitate the insertion of the device -1- by the esophageal route of the patient.
  • a connecting element -8- is used that joins part of said distal end -22- of said guide tube -2- with the distal end of the balloon -5- in a deflated state.
  • the preguiding filament -4- guides the assembly formed by the union of said guide tube -2- and said balloon inflation tube -3-, ensuring the correct entry of said assembly directly into the stomach -100 -, avoiding the possibility that said set is directed by the tracheal route -103-.
  • a liquid is injected such as, for example, a saline solution through said swelling tube -3- by means of a syringe -6- connected to the proximal end -31- of said tube -3- that is outside the patient.
  • Said liquid injection crosses the through hole of the tube -3- until it reaches and fills the inside of the balloon -5-.
  • Said balloon -5- comprises a valve -51- unidirectional liquid inlet that only allows liquid to enter the ball -5-.
  • the assembly formed by the union of said guide tube -2- and said swelling tube -3- are first removed by stretching said assembly outwards and maintaining the position of said preguiding filament -4-, as shown in figure 9. Finally, the preguiding filament -4- is gently pulled out of it towards the outside of the patient, as shown in figure 10.

Landscapes

  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif d'introduction de ballon gastrique du type qui comprend un guide possédant une extrémité distale et une extrémité proximale; un tube pour gonfler un ballon qui définit une extrémité distale et une extrémité proximale; un ballon gonflable uni à l'extrémité proximale dudit tube de gonflage, caractérisé en ce que le guide présente un orifice passant entre lesdites extrémités distale et proximale.
PCT/ES2011/070868 2010-12-29 2011-12-15 Dispositif d'introduction gastrique WO2012089881A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201032000A ES2356655B1 (es) 2010-12-29 2010-12-29 Dispositivo introductor gástrico.
ESP201032000 2010-12-29

Publications (1)

Publication Number Publication Date
WO2012089881A1 true WO2012089881A1 (fr) 2012-07-05

Family

ID=43797487

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2011/070868 WO2012089881A1 (fr) 2010-12-29 2011-12-15 Dispositif d'introduction gastrique

Country Status (2)

Country Link
ES (1) ES2356655B1 (fr)
WO (1) WO2012089881A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2525771A1 (es) * 2014-09-26 2014-12-29 Ramón ABAD BELANDO Dispositivo introductor de balón hinchable
WO2023073262A1 (fr) 2021-10-25 2023-05-04 Ramon Abad Belando Dispositif d'introduction de ballon intragastrique gonflable

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4485805A (en) * 1982-08-24 1984-12-04 Gunther Pacific Limited Of Hong Kong Weight loss device and method
US4723547A (en) * 1985-05-07 1988-02-09 C. R. Bard, Inc. Anti-obesity balloon placement system
US4899747A (en) * 1981-12-10 1990-02-13 Garren Lloyd R Method and appartus for treating obesity
US4925446A (en) * 1988-07-06 1990-05-15 Transpharm Group Inc. Removable inflatable intragastrointestinal device for delivering beneficial agents
US5391158A (en) * 1994-02-24 1995-02-21 Peters; Michael J. Nasogastric tube
US5868141A (en) * 1997-05-14 1999-02-09 Ellias; Yakub A. Endoscopic stomach insert for treating obesity and method for use

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4899747A (en) * 1981-12-10 1990-02-13 Garren Lloyd R Method and appartus for treating obesity
US4485805A (en) * 1982-08-24 1984-12-04 Gunther Pacific Limited Of Hong Kong Weight loss device and method
US4723547A (en) * 1985-05-07 1988-02-09 C. R. Bard, Inc. Anti-obesity balloon placement system
US4925446A (en) * 1988-07-06 1990-05-15 Transpharm Group Inc. Removable inflatable intragastrointestinal device for delivering beneficial agents
US5391158A (en) * 1994-02-24 1995-02-21 Peters; Michael J. Nasogastric tube
US5868141A (en) * 1997-05-14 1999-02-09 Ellias; Yakub A. Endoscopic stomach insert for treating obesity and method for use

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2525771A1 (es) * 2014-09-26 2014-12-29 Ramón ABAD BELANDO Dispositivo introductor de balón hinchable
WO2016046427A1 (fr) 2014-09-26 2016-03-31 Ramon Abad Belando Dispositif d'introduction d'un ballon gonflable
US10537457B2 (en) 2014-09-26 2020-01-21 Ramon Abad Belando Device for inserting an inflatable balloon
WO2023073262A1 (fr) 2021-10-25 2023-05-04 Ramon Abad Belando Dispositif d'introduction de ballon intragastrique gonflable

Also Published As

Publication number Publication date
ES2356655A1 (es) 2011-04-12
ES2356655B1 (es) 2011-11-22

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