[go: up one dir, main page]

WO2011041864A1 - Device and method for treatment of obesity by an intragastric balloon - Google Patents

Device and method for treatment of obesity by an intragastric balloon Download PDF

Info

Publication number
WO2011041864A1
WO2011041864A1 PCT/BR2010/000331 BR2010000331W WO2011041864A1 WO 2011041864 A1 WO2011041864 A1 WO 2011041864A1 BR 2010000331 W BR2010000331 W BR 2010000331W WO 2011041864 A1 WO2011041864 A1 WO 2011041864A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
tube
nozzle
distal end
interior
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/BR2010/000331
Other languages
French (fr)
Inventor
Elias Pereira de MAGALHÃES
Kiyoshi Hashiba
Pablo Rodrigo Siqueira
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.)
Hp Bioproteses Ltda
Original Assignee
Hp Bioproteses Ltda
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
Priority claimed from BRPI1001214-1A external-priority patent/BRPI1001214A2/en
Application filed by Hp Bioproteses Ltda filed Critical Hp Bioproteses Ltda
Publication of WO2011041864A1 publication Critical patent/WO2011041864A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1054—Balloon catheters with special features or adapted for special applications having detachable or disposable balloons

Definitions

  • the present invention refers to a device and a method to be used in the treatment of obesity, by introducing an inflatable balloon into the patient's stomach, further allowing the balloon to be controllably filled and deflated while remaining in the interior of the gastric cavity, and also withdrawn from the patient.
  • a balloon which can be preferably filled with gases or X-ray opaque liquid substances, for example, saline and a contrast liquid.
  • gases or X-ray opaque liquid substances for example, saline and a contrast liquid.
  • these balloons are constructed with materials very similar to those of saline inflatable breast implants.
  • the synthetic materials used are those biocompatible and adequate to this type of implant and inert to stomach acids.
  • the device comprises an orogastric tube, housing a working string with a proximal end and a distal end affixing a tubular adapter, said ends of the working string being maintained externally to one of the ends of the orogastric tube.
  • the orogastric tube is introduced through the patient' s mouth, in order to have a distal end housed in the interior of the stomach and a free proximal end maintained external to the patient, together with the proximal end and the distal end of the working string, in which the adapter is affixed.
  • the balloon is then rolled up in a deflated condition and housed in the interior of the tubular adapter, the retention valve of the balloon receiving an insertion end of a fill tube having a control end to be connected to a syringe or other adequate fluid pumping device.
  • the working string is then pulled by its proximal end, causing the displacement of the tubular adapter, of the balloon housed therein and of the fill tube, to inside the patient and towards the distal end of the orogastric tube in the interior of the stomach.
  • the stiffener wire can be removed from the orogastric tube and the balloon is filled through the fill tube and by actuation of the pumping device, until the filling degree causes the balloon to expand sufficiently to rupture the tubular adapter and to unfasten itself from the latter.
  • the fill tube is withdrawn, as well as the orogastric tube and the pull string still housed therein.
  • the retention valve of the balloon prevents leak from occurring after removing the insertion end of the fill tube from its engagement with the balloon.
  • this prior art device requires the provision of the orogastric tube and its introduction until the patient's stomach, without image assistance of an endoscopic instrument, requiring especial cares and, generally, a longer time for the operator or surgeon to carry out a correct and safe introduction of the orogastric tube.
  • this tube becomes a guide element for the working string, which will function as a pulling element in the subsequent operation defined by the introduction of the balloon coupled to the fill tube.
  • the time required for the procedure may be undesirably long, submitting the patient to long periods of anesthesia or sedation.
  • Another drawback of the solution proposed in this first prior art is the likely difficulty in pulling back the balloon, without risk of uncoupling the balloon from the fill tube, during the introduction process jointly with the tubular adapter, whenever there is a greater than usual resistance in the introduction path of the balloon until the patient's stomach.
  • the balloon can be introduced in the interior of the stomach by different methods and devices, such as, for example, that described in Patent US 4,485,805, that is, with the assistance of an orogastric tube housing a working string and a stiffener wire, and of a fill tube, said tubes being removed after positioning and filling the balloon in the interior of the stomach.
  • the balloon further carries a permanent magnet, positioned in the region of the retention valve, to capture and direct to said valve the insertion end, also provided with a magnet, of a fill tube, to be connected to the retention valve of the balloon in the interior of the patient's stomach.
  • the surgeon can then insert, into the patient's stomach, an endoscopic instrument carrying a fill tube, whose insertion end is provided with a magnet which is attracted by the magnet provided in the region of the retention valve of the balloon.
  • the endoscopic instrument is operatively associated with a device provided with a pair of end jaws or tweezers, so as to allow the grasping tab of the balloon to be grasped and the balloon to be securely maintained with its valve facing the operator.
  • the operator can then displace the fill tube, so as to allow its insertion end to be magnetically attracted by the magnet of the balloon and correctly positioned.
  • a filling instrument can be inserted in the interior of the balloon, through its retention valve, allowing partially or fully filling or deflating the balloon.
  • connection between the fill tube and the retention valve of the balloon, as well as the magnetic attraction, are not sufficiently strong to support the perforation forces of the retention valve and to allow the balloon to be withdrawn only by extracting the fill tube, without disconnecting or uncoupling the latter in relation to the retention valve, that is, to the balloon.
  • a device for treatment of obesity by an intragastric balloon comprising an introduction kit including :
  • a guide string to be endoscopically introduced into the patient and having an enlarged and flexible distal end positioned in the interior of the patient's stomach, and a free proximal end positioned externally to the patient's mouth;
  • a balloon in an inflatable material and provided with a retention valve which is coupled to an internally threaded nozzle opened to the outside of the balloon, which is housed, in a fully deflated condition, in the interior of the tubular sleeve;
  • a fill tube in a flexible material, presenting a distal end provided with an externally threaded axial nozzle which is engaged in the internally threaded nozzle of the balloon;
  • a capillary tube disposed, longitudinally displaceable, in the interior of the fill tube, and presenting a distal end introduced in the balloon, through its retention valve, and a proximal end to be coupled to a fluid pumping device.
  • the present device can also be defined, independently of the introduction kit, by a withdrawal and inflation- adjustment kit for an intragastric balloon, provided with a retention valve which is coupled to an internally threaded nozzle opened to the outside of the balloon, said kit including:
  • a guide tube in a flexible material, having an open distal end to be orally introduced in the interior of the patient's stomach, and a proximal end to be maintained external to the patient;
  • connection tube also in a flexible material and disposed, longitudinally displaceable, in the interior of the guide tube, and presenting an externally threaded end to be engaged with the nozzle of the balloon and a free proximal end projecting outwardly from the open proximal end of the internal tube;
  • a capillary tube disposed, longitudinally displaceable, in the interior of the guide tube, and presenting a distal end to be introduced into the balloon, through its retention valve, and a proximal end to be coupled to a fluid pumping device.
  • the withdrawal and inflation-adjustment kit further comprises an internal tube, also in a flexible material, longitudinally slidably disposed in the interior of the guide tube, and having an open distal end external to the distal end of the guide tube and around which is attached a permanent magnet, to be seated against a permanent magnet attached to the intragastric balloon, surrounding the internally threaded nozzle of the latter, and an open proximal end external to the proximal end of the guide tube.
  • the connection tube is slidably disposed in the interior of said internal tube.
  • a method for treatment of obesity comprising steps related to the use of the introduction kit and to the use of the withdrawal and inflation-adjustment kit.
  • Said method when regarding the use of the introduction kit, comprises the steps of:
  • the method when related to the use of the withdrawal and inflation-adjustment kit, comprises the steps of:
  • connection tube in the interior of the guide tube or of the internal tube, if existent, until its externally threaded end meets the nozzle of the balloon;
  • connection tube rotating the connection tube, so as to provide the engagement of its externally threaded end with the internally threaded nozzle of the balloon;
  • the device and the method generically define above allow obtaining all the advantages mentioned above in the introductory part of the present summary.
  • Figure 1 illustrates a perspective view of the distal end region of the introduction kit of the device of the present invention, before implantation of the balloon into the patient's stomach;
  • Figure 2 represents a longitudinal sectional view, in a somewhat schematic and simplified form, of the assembly formed by elements of the introduction kit, illustrating the tubular guide element, mounted around a respective extension of the guide tube and carrying the conical tip, the tubular sleeve still closed and housing the balloon in a deflated condition and with its internally threaded nozzle deprived of the magnet and engaged to the internally threaded end of the fill tube and with its retention valve trespassed by the distal end of the capillary tube;
  • Figure 2A represents an enlarged detail of part of figure 2, illustrating a constructive variant for the balloon, which presents its internally threaded nozzle deprived of the permanent magnet and also associated with an engaging element defined by at least one grasping loop;
  • Figure 3 represents an exploded and enlarged longitudinal sectional view of the balloon and of the distal end region of the introduction kit, according to the embodiment illustrated in figure 2;
  • Figure 3A represents a view similar to that of figure 3, but illustrating the balloon construction considered in figure 2A, that is, deprived of the magnet around the internally threaded nozzle and incorporating an engaging element in the form of a grasping loop;
  • Figure 4 represents a partial perspective view of the balloon illustrated in the constructive variant of figures 2A and 3A, already in its inflated condition;
  • Figure 5 represents a partial side view of the balloon of figures 2A, 3A and 4 illustrating, in a side elevation, the region of the nozzle and of the engaging element;
  • Figure 6 represents a perspective view of a longitudinal section of the internally threaded nozzle, of the balloon illustrated in figures 2A, 3A, 4 and 5;
  • Figure 7 illustrates a longitudinal sectional view of the withdrawal and inflation-adjustment kit of the device of the present invention, before its insertion in the patient' s stomach;
  • Figure 7A represents a view similar to that of figure 7, but illustrating a constructive variant for the withdrawal and inflation-adjustment kit, to be used in a balloon whose magnet was suppressed and replaced by the engaging element.
  • a first aspect of the invention refers to a device for treatment of obesity, which makes use of an intragastric balloon 10, in an inflatable material, which is adequate and inert to the acid medium of the stomach and provided with an inner retention valve 11, the latter having a known conventional construction to provide its self- closure when not trespassed by a tubular inflation needle.
  • the retention valve 11 is coupled to an internally threaded nozzle 12.
  • the balloon is provided with a magnet 13, of the permanent type and preferably with an annular shape, concentrically disposed around the nozzle 12.
  • the nozzle 12 of the balloon 10 further carries, externally and around the latter, at least one grasping tab 14, projecting radially from the nozzle 12 and constructed in a plastic material, which is also inert to the stomach acids and configured to allow its easy grasping by a pair of jaws (not illustrated) , pertaining to a device operatively associated with the endoscopic instrument and to be used in procedures related to the adjustment of the inflation degree of the balloon and to its withdrawal from the patient.
  • the balloon 10 is deprived of the magnet 13 and, in its place, is provided an engaging element 15 external to the balloon 10, in the region of the nozzle 12 and axially spaced from the latter and which can take the form of one or more grasping loops 15a, in a flexible material, disposed in front of the nozzle 12 of the balloon 10.
  • the two grasping loops 15a are medianly joined to each other in a region located in front of the nozzle 12 and axially spaced from the latter, and have their ends affixed to the balloon 10, for example, in the grasping tabs 14. This disposition allows a pull string 17 (or a non- illustrated endoscopic clamp) to be applied to the junction region or central region of the grasping loops during the operations for adjusting the inflation of the balloon and for withdrawing it.
  • the application of the pull string 17 or of the endoscopic clamp to the central region of the grasping loops 15a allows the operator to pull the balloon 10, making the nozzle 12 be adequately and securely positioned facing the esophagus, that is, facing the operator, during the procedures for adjusting the inflation and for withdrawal of the balloon 10.
  • the engaging element 15 can be defined by only one grasping loop 15a, provided that this presents a* region disposed in front of the nozzle 12, which is coaxial or approximately coaxial to the latter and capable of allowing maintaining the tie of the pull string 17 (or endoscopic clamp) in a region coaxial or approximately coaxial to the nozzle 12.
  • the pulling force applied to the engaging element 15 tends to pull the balloon 10 against the esophagus, with the axis of the nozzle 12 adequately positioned to be more easily accessed by the operator.
  • the present device comprises at least one pair of kits herein denominated introduction kit and withdrawal and inflation-adjustment kit.
  • the introduction kit as illustrated in figures 1, 2, 2A, 3 and 3A, includes a guide string 20, in an adequate material for orogastric insertion, having an enlarged distal end 21,. to be positioned in the interior of the patient's stomach, and a free proximal end 22, to be maintained externally to the oral via of the patient.
  • tubular guide element 30 generally formed by a helical spring extension coated by a cover made of inert synthetic material and carrying a conical tip 31, also in a synthetic material and with a tubular configuration, onto which is affixed an end region of a tubular sleeve 32, made of a flexible material, for example, a non-woven fabric, presenting a longitudinal seam 32a, with or without string, designed to be ruptured when submitted to the expansion of the balloon 10 which is housed in its interior, in a fully deflated condition and with its nozzle 12 projecting outwardly from the open end of the tubular sleeve 32 and opposite to that end attached around the conical tip 31.
  • a fill tube 40 in a flexible material and adequate to the formation of orogastric catheters, presents a distal end 41, provided with an externally threaded axial nozzle 41a, to be engaged in the internally threaded nozzle 12 of the balloon 10, as better illustrated in figures 2, 2A, 3 and 3A.
  • a capillary tube 50 In the interior of the fill tube 40, there is disposed, longitudinally displaceable, a capillary tube 50, presenting a distal end 51, generally in the form of a tubular needle, to be introduced into the balloon 10, through its retention valve 11, and a proximal end 52, preferably provided with a thread 52a and in which is coupled a fluid pumping device (not illustrated) , which can have the form of a syringe.
  • the method for treatment of obesity by an intragastric balloon using a device formed by the above defined introduction kit comprises the steps of: endoscopically introducing, in a patient, the guide string 20, until its enlarged and flexible distal end 21 is positioned in the interior of the patient's stomach; introducing, in the patient, the fill tube 40 carrying the tubular guide element 30, the conical tip 31, the tubular sleeve 32 and the balloon 10 in the deflated condition, until the tubular guide element 30, by sliding along the guide string 20, reaches the interior of the patient's stomach.
  • the balloon 10 is filled with a predetermined quantity of liquid or gaseous fluid, for example, air, through the capillary tube 50, producing the rupture of the tubular sleeve 32 and the release of the already insufflated balloon 10 from the ruptured tubular sleeve 32.
  • a predetermined quantity of liquid or gaseous fluid for example, air
  • the guide string 20 can be then pulled out from the patient, together with the tubular guide element 30, the conical tip 31 and the ruptured tubular sleeve 32.
  • the capillary tube 50 is then longitudinally displaced until its distal end 51 is withdrawn from the interior of the retention valve 11, allowing the automatic closure of the latter, with the balloon maintaining the insufflated condition .
  • the fill tube 40 can be then rotated around its axis, so that its externally threaded axial nozzle 41a is disengaged from the internally threaded nozzle 12, of the balloon 10, maintaining the latter in the interior of the patient's stomach.
  • the fill tube 40 can be then removed from the patient.
  • the withdrawal and inflation-adjustment kit of an intragastric balloon includes a guide tube 60, in a flexible material, having an open distal end 61 to be orally introduced in the interior of the patient' s stomach and, around which can be affixed a permanent magnet M to be seated against the permanent magnet 13 of the nozzle 12 of the balloon 10, and an open proximal end 62 to be maintained externally to the patient.
  • the withdrawal and inflation-adjustment kit further includes an inner tube 70, also in a flexible material, longitudinally and slidably disposed in the interior of the guide tube 60, and having an open distal end 71 external to the distal end 61 of the guide tube 60 and around which there is attached the permanent magnet M, to be seated against the permanent magnet 13 of the nozzle 12 of the balloon 10.
  • the inner tube 70 further presents an open proximal end 72 external to the proximal end 62 of the guide tube 60.
  • a support 65 generally in the form of double loop, in a plastic flexible material and inert to the patient's body and which is configured to house and attach a penetrating end portion of an endoscopic instrument (not illustrated) , to allow the guide tube 60 to be endoscopically introduced in the interior of the patient, and to guarantee that the operator adequately visualizes the inner region of the patient in which lies the distal end of the guide tube 60 during its introduction operation.
  • the operator can displace the inner tube 70 so that the permanent magnet M, affixed around the distal end 71 of the inner tube 70, can be longitudinally displaced against the permanent magnet 13 of the balloon 10.
  • both the permanent magnet 13 of the nozzle 12 of the balloon 10 and the permanent magnet M of the distal end 71 of the inner tube 70 (or optionally, of the distal end 61 of the guide tube 60, in case there is no inner tube 70), present a shape concentric to the axis of the part to which they are attached, allowing the magnetic attraction therebetween to occur so as to seat them concentrically one into the other.
  • the inner tube 70 can be suppressed, in which situation the permanent magnet M will be affixed directly around the distal end 61 of the guide tube 60.
  • the permanent magnet M is suppressed, the same occurring with the inner tube 70 which is suppressed.
  • the withdrawal and inflation-adjustment kit is used together with a balloon 10 provided with the engaging element 15, as illustrated in figures 2A and 3A.
  • the withdrawal and inflation-adjustment kit further includes a connection tube 80, also in a flexible material and longitudinally displaceably disposed in the interior of the guide tube 60 or of the inner tube 70, if the latter is provided, said connection tube 80 presenting an externally threaded distal end 81, to be ' engaged with the nozzle 12 of the balloon 10 and a proximal end 82 projecting outwardly from the proximal end 72 of the inner tube 70 and, consequently, from the distal end 61 of the guide tube 60.
  • a connection tube 80 also in a flexible material and longitudinally displaceably disposed in the interior of the guide tube 60 or of the inner tube 70, if the latter is provided, said connection tube 80 presenting an externally threaded distal end 81, to be ' engaged with the nozzle 12 of the balloon 10 and a proximal end 82 projecting outwardly from the proximal end 72 of the inner tube 70 and, consequently, from the distal end 61 of the guide tube 60.
  • connection tube 80 The externally threaded distal end 81 of the connection tube 80 is configured to be engaged with the internally threaded nozzle 12 of the balloon 10.
  • a capillary tube 90 is disposed, longitudinally displaceable in the interior of the connection tube 80, presenting a distal end 91, generally in the form of a tubular needle, to be introduced into the balloon 10, through its retention valve 11, and a proximal end 92, preferably provided with a thread 92a, to be coupled to a fluid pumping device (not illustrated) , for example, a syringe .
  • the method for the treatment of obesity by an intragastric balloon using a device comprising the withdrawal and inflation-adjustment kit of the intragastric balloon, as illustrated in figures 2, 3 and 7, comprises the initial step of introducing, in a patient with an already implanted balloon 10, endoscopically positioned and retained in the interior of the patient's stomach, the guide tube 60, until the distal end 61 is adequately positioned in front of the nozzle 12, of the balloon 10, previously positioned and retained, by the endoscopic instrument, with its nozzle 12 facing the operator.
  • the positioning and the retention of the balloon 10 in the stomach cavity is generally achieved by the actuation of end jaws, which are carried by the device associated with the endoscopic instrument (not illustrated) and pressed onto a grasping tab 14 which projects from the nozzle 12 of the balloon 10.
  • the operator should position said distal end 61 in front of the nozzle 12 of the balloon 10, so that the two magnets 13, M are attracted and seated one against the other.
  • the method includes the step of longitudinally displacing the inner tube 70, so that the permanent magnet is more easily positioned in the magnetic attraction field of the permanent magnet 13 of the nozzle 12 of the balloon 10, so as to allow a correct and coaxial seating between the two magnets.
  • the method of using the withdrawal and inflation-adjustment kit comprises pre-positioning the balloon 10 in the interior of the stomach.
  • the end jaws of the endoscopic instrument (not illustrated) can be pressed on one of the grasping tab 14 of the balloon 10, so as to make its nozzle 12 and, consequently, the engaging element 15 (grasping loops 15a) face the esophagus, that is, face the operator.
  • the pull string 17 (or endoscopic clamp) can be then applied to the central region of the grasping loops 15a, so that its tips (or portions) , external to the patient, can be pulled to seat and retain the balloon 10 against the upper region of the stomach, maintaining the nozzle 12 facing the esophagus to be easily accessed by the distal end 81 of the connection tube 80.
  • connection tube 80 is longitudinally displaced in the interior of the inner tube 70, or directly in the interior of the guide tube 60, until its externally threaded distal end 81 meets the internally threaded nozzle 12 of the balloon 10.
  • the connection tube 80 is then rotated, so as to provide its engagement with the nozzle 12 of the balloon 10.
  • the pull string 17, if used, can be thus extracted from the patient.
  • the capillary tube 90 can be longitudinally displaced in the interior of the connection tube 80, until its distal end 91, in the form of a tubular needle, is introduced into the balloon 10, through its retention valve 11.
  • a liquid or gaseous fluid such as for example, air or gas
  • the capillary tube 90 is longitudinally displaced, in order to extract its distal end 91 from the interior of the balloon 10 and from the retention valve 11, with the connection tube 80 then being rotated around its axis, so as to allow uncoupling its externally threaded distal end 81 in relation to the internally threaded nozzle 12 of the balloon 10, allowing the latter to remain in the interior of the stomach, with the new inflation adj ustment .
  • connection tube 80 still engaged in the nozzle 12 of the balloon 10, is extracted from the interior of the patient, jointly with the capillary tube 90, the inner tube 70, if existent, and the guide tube 60.

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)
  • Surgical Instruments (AREA)

Abstract

The invention refers to the provision of at least one of two kits, one for introducing the balloon (10) into the stomach cavity of the patient, along a guide string (20) which is previously and orally introduced into the patient, and the other kit being used for withdrawal and inflation adjustment of the balloon (10), the latter having a retention valve (11) coupled to an internally threaded nozzle (12) for engaging a distal end (41) of a fill tube (40) or a distal end (81) of a connection tube (80), one of said tubes (40, 80) internally carrying a respective capillary tube (50, 90) having a distal end (51, 91) to be inserted through the balloon retention valve (11) and a proximal end (52, 92) to be coupled to the device for pumping a liquid or gaseous fluid into and out from the balloon (10).

Description

DEVICE AND METHOD FOR TREATMENT OF OBESITY BY AN INTRAGASTRIC BALLOON
Field of the Invention
The present invention refers to a device and a method to be used in the treatment of obesity, by introducing an inflatable balloon into the patient's stomach, further allowing the balloon to be controllably filled and deflated while remaining in the interior of the gastric cavity, and also withdrawn from the patient.
Background of the Invention
There are known different devices and methods for the treatment of obesity by using an inflatable balloon in the interior of the patient's stomach. These known solutions aim at allowing the operations of safely introducing, adjusting and withdrawing the balloon, with a minimum harm to the patient's internal organs and through means presenting a technically and economically feasible construction.
One of these known solutions is described and illustrated in patent US 4,485,805. According to this prior art solution, there is provided a balloon which can be preferably filled with gases or X-ray opaque liquid substances, for example, saline and a contrast liquid. Generally, these balloons are constructed with materials very similar to those of saline inflatable breast implants. The synthetic materials used are those biocompatible and adequate to this type of implant and inert to stomach acids.
In this prior art construction, the device comprises an orogastric tube, housing a working string with a proximal end and a distal end affixing a tubular adapter, said ends of the working string being maintained externally to one of the ends of the orogastric tube. The orogastric tube is introduced through the patient' s mouth, in order to have a distal end housed in the interior of the stomach and a free proximal end maintained external to the patient, together with the proximal end and the distal end of the working string, in which the adapter is affixed. Next, it is introduced in the interior of the orogastric tube a stiffener wire, whose distal end is maintained spaced back in relation to the distal end of the orogastric tube. The balloon is then rolled up in a deflated condition and housed in the interior of the tubular adapter, the retention valve of the balloon receiving an insertion end of a fill tube having a control end to be connected to a syringe or other adequate fluid pumping device.
The working string is then pulled by its proximal end, causing the displacement of the tubular adapter, of the balloon housed therein and of the fill tube, to inside the patient and towards the distal end of the orogastric tube in the interior of the stomach.
Subsequently, the stiffener wire can be removed from the orogastric tube and the balloon is filled through the fill tube and by actuation of the pumping device, until the filling degree causes the balloon to expand sufficiently to rupture the tubular adapter and to unfasten itself from the latter. After filling the balloon, the fill tube is withdrawn, as well as the orogastric tube and the pull string still housed therein. The retention valve of the balloon prevents leak from occurring after removing the insertion end of the fill tube from its engagement with the balloon.
Although enabling the introduction of the deflated balloon in the interior of the patient's stomach, this prior art device requires the provision of the orogastric tube and its introduction until the patient's stomach, without image assistance of an endoscopic instrument, requiring especial cares and, generally, a longer time for the operator or surgeon to carry out a correct and safe introduction of the orogastric tube. Thus, this tube becomes a guide element for the working string, which will function as a pulling element in the subsequent operation defined by the introduction of the balloon coupled to the fill tube.
Moreover, in this prior art solution, it is required a laborious and usually time-consuming operation, so that the operator can couple again the insertion end of the fill tube in the retention valve of the balloon, in operations for adjusting its filling degree, during the period in which said balloon remains in the patient. The displacement of the balloon while remaining in the stomach cavity, with the purpose of visually locating the retention valve, is very difficult and the process for adequately positioning the retention valve undesirably prolongs the procedure, even when the balloon is provided with a loop tab or grasping tab close to the place for positioning the retention valve. Even after visually locating the retention valve, it is generally still difficult for the surgeon to reinsert the fill tube in said retention valve of the balloon, since the latter tends to easily rotate in the interior of the patient' s stomach in different positions.
Besides the operational difficulties in coupling the fill tube to a balloon previously positioned in the patient' s stomach, the time required for the procedure may be undesirably long, submitting the patient to long periods of anesthesia or sedation.
Another drawback of the solution proposed in this first prior art is the likely difficulty in pulling back the balloon, without risk of uncoupling the balloon from the fill tube, during the introduction process jointly with the tubular adapter, whenever there is a greater than usual resistance in the introduction path of the balloon until the patient's stomach.
The same inconveniences are verified when the balloon is required to be deflated, so as to remove it through the cardia and esophagus of the patient.
Another prior art solution is described in the international patent application PCT/US2007/080017 (WO 2008/042819-A2) . In this second prior art solution, there is provided a device and a method, particularly regarding the adjustment of the filling of an intragastric balloon already previously positioned in the patient's stomach. According to the proposed solution, the balloon presents, besides the usual retention valve, a grasping tab or loop tab which allows the surgeon to capture and securely hold the balloon, using a specialized endoscopic instrument, which also includes a filling instrument for adjusting the volume of the fluid contained within the balloon.
In this previous document, it is disclosed that the balloon can be introduced in the interior of the stomach by different methods and devices, such as, for example, that described in Patent US 4,485,805, that is, with the assistance of an orogastric tube housing a working string and a stiffener wire, and of a fill tube, said tubes being removed after positioning and filling the balloon in the interior of the stomach.
Besides the provision of the loop tab or grasping tab close to the retention valve, the balloon further carries a permanent magnet, positioned in the region of the retention valve, to capture and direct to said valve the insertion end, also provided with a magnet, of a fill tube, to be connected to the retention valve of the balloon in the interior of the patient's stomach.
With the characteristics mentioned above, the surgeon can then insert, into the patient's stomach, an endoscopic instrument carrying a fill tube, whose insertion end is provided with a magnet which is attracted by the magnet provided in the region of the retention valve of the balloon.
The endoscopic instrument is operatively associated with a device provided with a pair of end jaws or tweezers, so as to allow the grasping tab of the balloon to be grasped and the balloon to be securely maintained with its valve facing the operator. The operator can then displace the fill tube, so as to allow its insertion end to be magnetically attracted by the magnet of the balloon and correctly positioned. Next, a filling instrument can be inserted in the interior of the balloon, through its retention valve, allowing partially or fully filling or deflating the balloon.
Although bringing improvements by facilitating the correct positioning of the balloon in the interior of the patient' s stomach and the access of the retention valve of the balloon by the filling instrument, this prior art solution still presents, as one of its inconveniences, the fact that the connection between the balloon and the assembly defined by the fill tube and the endoscopic instrument is obtained by pressing the end jaws, of the device associated with the endoscopic instrument, on the grasping tab of the balloon. Thus, in the operations for removing the balloon by oral via, it is required to hold the fastening of the jaws, of the device associated with the endoscopic instrument, on the grasping tab, while the balloon is pulled away from the patient.
The connection between the fill tube and the retention valve of the balloon, as well as the magnetic attraction, are not sufficiently strong to support the perforation forces of the retention valve and to allow the balloon to be withdrawn only by extracting the fill tube, without disconnecting or uncoupling the latter in relation to the retention valve, that is, to the balloon.
Other drawback of this second prior art solution relates to the fact that the balloon is pulled out from the patient's body by the grasping tab, which is positioned eccentrically to the longitudinal axis of the retention valve, making the balloon, in its displacement, be positioned inclined in relation to the displacement direction of the assembly, with the risk of provoking trauma or injuries in the internal mucous of the patient. Finally, it should be further noted that, during the operations of adjusting the filling of the balloon or its full deflating, it is required special attention of the operator to hold the balloon adequately and securely immobilized by pressing the jaws, of the device operatively associated with the endoscopic instrument, on the grasping tab.
Only the provision of the retention of the grasping tab does not guarantee the access to the retention valve through the fill tube, since there is an operational difficulty in keeping the balloon immobilized and also in approximating the two components aligned in the same axis.
Summary of the Invention
As a function of the inconveniences mentioned above and related to the prior art, it is an object of the present invention to provide a device and a method for treatment of obesity by an intragastric balloon, in a patient who needs the treatment, the device and the method guaranteeing that the operations for introducing, adjusting the filling and withdrawing the intragastric balloon are safe, easier and quicker to the operator, shortening the sedation or anesthesia time for the patient and the risks of trauma or injuries to the tissue of the digestive tract which is submitted to contact with the balloon and with the means for introducing, adjusting and withdrawing the latter.
According to a first aspect of the present invention, it is provided a device for treatment of obesity by an intragastric balloon, comprising an introduction kit including :
(a) a guide string to be endoscopically introduced into the patient and having an enlarged and flexible distal end positioned in the interior of the patient's stomach, and a free proximal end positioned externally to the patient's mouth;
(b) a tubular guide element slidably mounted around the guide string, and carrying a conical tip onto which is attached a tubular sleeve made of flexible material;
(c) a balloon, in an inflatable material and provided with a retention valve which is coupled to an internally threaded nozzle opened to the outside of the balloon, which is housed, in a fully deflated condition, in the interior of the tubular sleeve;
(d) a fill tube, in a flexible material, presenting a distal end provided with an externally threaded axial nozzle which is engaged in the internally threaded nozzle of the balloon; and
(e) a capillary tube disposed, longitudinally displaceable, in the interior of the fill tube, and presenting a distal end introduced in the balloon, through its retention valve, and a proximal end to be coupled to a fluid pumping device.
The present device can also be defined, independently of the introduction kit, by a withdrawal and inflation- adjustment kit for an intragastric balloon, provided with a retention valve which is coupled to an internally threaded nozzle opened to the outside of the balloon, said kit including:
(i) a guide tube, in a flexible material, having an open distal end to be orally introduced in the interior of the patient's stomach, and a proximal end to be maintained external to the patient;
(ii) a connection tube, also in a flexible material and disposed, longitudinally displaceable, in the interior of the guide tube, and presenting an externally threaded end to be engaged with the nozzle of the balloon and a free proximal end projecting outwardly from the open proximal end of the internal tube; and
(iii) a capillary tube disposed, longitudinally displaceable, in the interior of the guide tube, and presenting a distal end to be introduced into the balloon, through its retention valve, and a proximal end to be coupled to a fluid pumping device.
In a preferred constructive form, the withdrawal and inflation-adjustment kit further comprises an internal tube, also in a flexible material, longitudinally slidably disposed in the interior of the guide tube, and having an open distal end external to the distal end of the guide tube and around which is attached a permanent magnet, to be seated against a permanent magnet attached to the intragastric balloon, surrounding the internally threaded nozzle of the latter, and an open proximal end external to the proximal end of the guide tube. In this case, the connection tube is slidably disposed in the interior of said internal tube.
Further according to the present invention, it is provided a method for treatment of obesity, comprising steps related to the use of the introduction kit and to the use of the withdrawal and inflation-adjustment kit. Said method, when regarding the use of the introduction kit, comprises the steps of:
- endoscopically introducing, in a patient, the guide string until its enlarged and flexible distal end is positioned in the interior of the patient's stomach;
- introducing, in the patient, the fill tube carrying the tubular guide element, the conical tip, the tubular sleeve and the deflated balloon, until the tubular guide element, by sliding along the guide string, reaches the interior of the patient's stomach;
- filling the balloon with a predetermined quantity of liquid or gaseous fluid, through the first capillary tube, producing the rupture of the tubular sleeve and the release of the already inflated balloon from the ruptured tubular sleeve;
- withdrawing the guide string carrying, away from the patient, the tubular guide, the conical tip and the ruptured tubular sleeve; and
- longitudinally displacing the capillary tube until its distal end is withdrawn from the interior of the retention valve, allowing the automatic closure of the latter; and
rotating the fill tube to uncouple its externally threaded axial nozzle from the internally threaded nozzle of the balloon, maintaining the latter in the interior of the patient's stomach.
On the other hand, the method, when related to the use of the withdrawal and inflation-adjustment kit, comprises the steps of:
- introducing, in a patient already containing said balloon endoscopically positioned and retained in the interior of the stomach, the guide tube, and displacing the latter or the internal tube, if existent, until its distal end is approximated to the internally threaded nozzle of the balloon, after said balloon has been positioned with said nozzle facing the distal end of the guide tube;
- longitudinally displacing the connection tube in the interior of the guide tube or of the internal tube, if existent, until its externally threaded end meets the nozzle of the balloon;
- rotating the connection tube, so as to provide the engagement of its externally threaded end with the internally threaded nozzle of the balloon;
- longitudinally displacing the capillary tube in the interior of the connection tube, until its distal end is introduced into the balloon through its retention valve;
- pumping liquid or gaseous fluid to the interior or exterior of the balloon, through the capillary tube, so as to adjust the volume of the balloon to the required operating conditions;
optionally, longitudinally displacing the capillary tube, so as to extract its distal end from the interior of the balloon and from the retention valve, and rotating the connection tube, for uncoupling its externally threaded end from the nozzle of the balloon, so as to maintain the latter in the interior of the stomach, with the new inflation adjustment; and
- alternatively to the previous optional step, extracting the withdrawal and inflation-adjustment kit from the interior of the patient, with the intragastric balloon being in a deflated condition but still engaged to the connection tube.
The device and the method generically define above allow obtaining all the advantages mentioned above in the introductory part of the present summary.
Brief Description of the Drawings
The invention will be described below, with reference to the enclosed drawings, given by way of example only and in which:
Figure 1 illustrates a perspective view of the distal end region of the introduction kit of the device of the present invention, before implantation of the balloon into the patient's stomach;
Figure 2 represents a longitudinal sectional view, in a somewhat schematic and simplified form, of the assembly formed by elements of the introduction kit, illustrating the tubular guide element, mounted around a respective extension of the guide tube and carrying the conical tip, the tubular sleeve still closed and housing the balloon in a deflated condition and with its internally threaded nozzle deprived of the magnet and engaged to the internally threaded end of the fill tube and with its retention valve trespassed by the distal end of the capillary tube;
Figure 2A represents an enlarged detail of part of figure 2, illustrating a constructive variant for the balloon, which presents its internally threaded nozzle deprived of the permanent magnet and also associated with an engaging element defined by at least one grasping loop;
Figure 3 represents an exploded and enlarged longitudinal sectional view of the balloon and of the distal end region of the introduction kit, according to the embodiment illustrated in figure 2;
Figure 3A represents a view similar to that of figure 3, but illustrating the balloon construction considered in figure 2A, that is, deprived of the magnet around the internally threaded nozzle and incorporating an engaging element in the form of a grasping loop; Figure 4 represents a partial perspective view of the balloon illustrated in the constructive variant of figures 2A and 3A, already in its inflated condition;
Figure 5 represents a partial side view of the balloon of figures 2A, 3A and 4 illustrating, in a side elevation, the region of the nozzle and of the engaging element;
Figure 6 represents a perspective view of a longitudinal section of the internally threaded nozzle, of the balloon illustrated in figures 2A, 3A, 4 and 5;
Figure 7 illustrates a longitudinal sectional view of the withdrawal and inflation-adjustment kit of the device of the present invention, before its insertion in the patient' s stomach; and
Figure 7A represents a view similar to that of figure 7, but illustrating a constructive variant for the withdrawal and inflation-adjustment kit, to be used in a balloon whose magnet was suppressed and replaced by the engaging element.
Detailed Description of the Invention
A first aspect of the invention refers to a device for treatment of obesity, which makes use of an intragastric balloon 10, in an inflatable material, which is adequate and inert to the acid medium of the stomach and provided with an inner retention valve 11, the latter having a known conventional construction to provide its self- closure when not trespassed by a tubular inflation needle. The retention valve 11 is coupled to an internally threaded nozzle 12. In the embodiment illustrated in figures 2 and 3, the balloon is provided with a magnet 13, of the permanent type and preferably with an annular shape, concentrically disposed around the nozzle 12.
The nozzle 12 of the balloon 10 further carries, externally and around the latter, at least one grasping tab 14, projecting radially from the nozzle 12 and constructed in a plastic material, which is also inert to the stomach acids and configured to allow its easy grasping by a pair of jaws (not illustrated) , pertaining to a device operatively associated with the endoscopic instrument and to be used in procedures related to the adjustment of the inflation degree of the balloon and to its withdrawal from the patient.
On the other hand, in the embodiment illustrated in figures 2A, 3A, 4, 5 and 6, the balloon 10 is deprived of the magnet 13 and, in its place, is provided an engaging element 15 external to the balloon 10, in the region of the nozzle 12 and axially spaced from the latter and which can take the form of one or more grasping loops 15a, in a flexible material, disposed in front of the nozzle 12 of the balloon 10. In the illustrated form, the two grasping loops 15a are medianly joined to each other in a region located in front of the nozzle 12 and axially spaced from the latter, and have their ends affixed to the balloon 10, for example, in the grasping tabs 14. This disposition allows a pull string 17 (or a non- illustrated endoscopic clamp) to be applied to the junction region or central region of the grasping loops during the operations for adjusting the inflation of the balloon and for withdrawing it.
The application of the pull string 17 or of the endoscopic clamp to the central region of the grasping loops 15a allows the operator to pull the balloon 10, making the nozzle 12 be adequately and securely positioned facing the esophagus, that is, facing the operator, during the procedures for adjusting the inflation and for withdrawal of the balloon 10.
It should be understood that the engaging element 15 can be defined by only one grasping loop 15a, provided that this presents a* region disposed in front of the nozzle 12, which is coaxial or approximately coaxial to the latter and capable of allowing maintaining the tie of the pull string 17 (or endoscopic clamp) in a region coaxial or approximately coaxial to the nozzle 12. Thus, the pulling force applied to the engaging element 15 tends to pull the balloon 10 against the esophagus, with the axis of the nozzle 12 adequately positioned to be more easily accessed by the operator.
The present device comprises at least one pair of kits herein denominated introduction kit and withdrawal and inflation-adjustment kit.
The introduction kit, as illustrated in figures 1, 2, 2A, 3 and 3A, includes a guide string 20, in an adequate material for orogastric insertion, having an enlarged distal end 21,. to be positioned in the interior of the patient's stomach, and a free proximal end 22, to be maintained externally to the oral via of the patient.
It is also provided a tubular guide element 30, generally formed by a helical spring extension coated by a cover made of inert synthetic material and carrying a conical tip 31, also in a synthetic material and with a tubular configuration, onto which is affixed an end region of a tubular sleeve 32, made of a flexible material, for example, a non-woven fabric, presenting a longitudinal seam 32a, with or without string, designed to be ruptured when submitted to the expansion of the balloon 10 which is housed in its interior, in a fully deflated condition and with its nozzle 12 projecting outwardly from the open end of the tubular sleeve 32 and opposite to that end attached around the conical tip 31.
A fill tube 40, in a flexible material and adequate to the formation of orogastric catheters, presents a distal end 41, provided with an externally threaded axial nozzle 41a, to be engaged in the internally threaded nozzle 12 of the balloon 10, as better illustrated in figures 2, 2A, 3 and 3A.
In the interior of the fill tube 40, there is disposed, longitudinally displaceable, a capillary tube 50, presenting a distal end 51, generally in the form of a tubular needle, to be introduced into the balloon 10, through its retention valve 11, and a proximal end 52, preferably provided with a thread 52a and in which is coupled a fluid pumping device (not illustrated) , which can have the form of a syringe.
The method for treatment of obesity by an intragastric balloon using a device formed by the above defined introduction kit, comprises the steps of: endoscopically introducing, in a patient, the guide string 20, until its enlarged and flexible distal end 21 is positioned in the interior of the patient's stomach; introducing, in the patient, the fill tube 40 carrying the tubular guide element 30, the conical tip 31, the tubular sleeve 32 and the balloon 10 in the deflated condition, until the tubular guide element 30, by sliding along the guide string 20, reaches the interior of the patient's stomach. Next, the balloon 10 is filled with a predetermined quantity of liquid or gaseous fluid, for example, air, through the capillary tube 50, producing the rupture of the tubular sleeve 32 and the release of the already insufflated balloon 10 from the ruptured tubular sleeve 32.
The guide string 20 can be then pulled out from the patient, together with the tubular guide element 30, the conical tip 31 and the ruptured tubular sleeve 32.
The capillary tube 50 is then longitudinally displaced until its distal end 51 is withdrawn from the interior of the retention valve 11, allowing the automatic closure of the latter, with the balloon maintaining the insufflated condition .
The fill tube 40 can be then rotated around its axis, so that its externally threaded axial nozzle 41a is disengaged from the internally threaded nozzle 12, of the balloon 10, maintaining the latter in the interior of the patient's stomach. The fill tube 40 can be then removed from the patient.
The withdrawal and inflation-adjustment kit of an intragastric balloon, as illustrated in figure 7, includes a guide tube 60, in a flexible material, having an open distal end 61 to be orally introduced in the interior of the patient' s stomach and, around which can be affixed a permanent magnet M to be seated against the permanent magnet 13 of the nozzle 12 of the balloon 10, and an open proximal end 62 to be maintained externally to the patient.
In the embodiment illustrated in figure 7, the withdrawal and inflation-adjustment kit further includes an inner tube 70, also in a flexible material, longitudinally and slidably disposed in the interior of the guide tube 60, and having an open distal end 71 external to the distal end 61 of the guide tube 60 and around which there is attached the permanent magnet M, to be seated against the permanent magnet 13 of the nozzle 12 of the balloon 10. The inner tube 70 further presents an open proximal end 72 external to the proximal end 62 of the guide tube 60. In this preferred constructive form, to the distal end 61 of the guide tube 60 is attached a support 65, generally in the form of double loop, in a plastic flexible material and inert to the patient's body and which is configured to house and attach a penetrating end portion of an endoscopic instrument (not illustrated) , to allow the guide tube 60 to be endoscopically introduced in the interior of the patient, and to guarantee that the operator adequately visualizes the inner region of the patient in which lies the distal end of the guide tube 60 during its introduction operation.
Thus, after the correct positioning of the guide tube 60, the operator can displace the inner tube 70 so that the permanent magnet M, affixed around the distal end 71 of the inner tube 70, can be longitudinally displaced against the permanent magnet 13 of the balloon 10.
In the embodiment illustrated in figures 2, 3 and 7, both the permanent magnet 13 of the nozzle 12 of the balloon 10 and the permanent magnet M of the distal end 71 of the inner tube 70 (or optionally, of the distal end 61 of the guide tube 60, in case there is no inner tube 70), present a shape concentric to the axis of the part to which they are attached, allowing the magnetic attraction therebetween to occur so as to seat them concentrically one into the other.
As mentioned above, the inner tube 70 can be suppressed, in which situation the permanent magnet M will be affixed directly around the distal end 61 of the guide tube 60. In the embodiment illustrated in figure 7A, the permanent magnet M is suppressed, the same occurring with the inner tube 70 which is suppressed. In this case, the withdrawal and inflation-adjustment kit is used together with a balloon 10 provided with the engaging element 15, as illustrated in figures 2A and 3A.
The withdrawal and inflation-adjustment kit further includes a connection tube 80, also in a flexible material and longitudinally displaceably disposed in the interior of the guide tube 60 or of the inner tube 70, if the latter is provided, said connection tube 80 presenting an externally threaded distal end 81, to be' engaged with the nozzle 12 of the balloon 10 and a proximal end 82 projecting outwardly from the proximal end 72 of the inner tube 70 and, consequently, from the distal end 61 of the guide tube 60.
The externally threaded distal end 81 of the connection tube 80 is configured to be engaged with the internally threaded nozzle 12 of the balloon 10.
A capillary tube 90 is disposed, longitudinally displaceable in the interior of the connection tube 80, presenting a distal end 91, generally in the form of a tubular needle, to be introduced into the balloon 10, through its retention valve 11, and a proximal end 92, preferably provided with a thread 92a, to be coupled to a fluid pumping device (not illustrated) , for example, a syringe .
The method for the treatment of obesity by an intragastric balloon, using a device comprising the withdrawal and inflation-adjustment kit of the intragastric balloon, as illustrated in figures 2, 3 and 7, comprises the initial step of introducing, in a patient with an already implanted balloon 10, endoscopically positioned and retained in the interior of the patient's stomach, the guide tube 60, until the distal end 61 is adequately positioned in front of the nozzle 12, of the balloon 10, previously positioned and retained, by the endoscopic instrument, with its nozzle 12 facing the operator.
The positioning and the retention of the balloon 10 in the stomach cavity is generally achieved by the actuation of end jaws, which are carried by the device associated with the endoscopic instrument (not illustrated) and pressed onto a grasping tab 14 which projects from the nozzle 12 of the balloon 10.
In case the permanent magnet M is affixed around the distal end 61 of said guide tube 60, the operator should position said distal end 61 in front of the nozzle 12 of the balloon 10, so that the two magnets 13, M are attracted and seated one against the other.
In case of providing the inner tube 70 with its distal end 71 affixing the permanent magnet M, the method includes the step of longitudinally displacing the inner tube 70, so that the permanent magnet is more easily positioned in the magnetic attraction field of the permanent magnet 13 of the nozzle 12 of the balloon 10, so as to allow a correct and coaxial seating between the two magnets.
In a somewhat different way, upon using the constructive embodiment deprived of the magnets 13 and M, in the balloon 10 and in the inner tube 70 or in the guide tube 60, as illustrated in figures 2A, 3A, 4, 5, 6 and 7A, the method of using the withdrawal and inflation-adjustment kit comprises pre-positioning the balloon 10 in the interior of the stomach. For this purpose, the end jaws of the endoscopic instrument (not illustrated) can be pressed on one of the grasping tab 14 of the balloon 10, so as to make its nozzle 12 and, consequently, the engaging element 15 (grasping loops 15a) face the esophagus, that is, face the operator.
The pull string 17 (or endoscopic clamp) can be then applied to the central region of the grasping loops 15a, so that its tips (or portions) , external to the patient, can be pulled to seat and retain the balloon 10 against the upper region of the stomach, maintaining the nozzle 12 facing the esophagus to be easily accessed by the distal end 81 of the connection tube 80.
Subsequently, the connection tube 80 is longitudinally displaced in the interior of the inner tube 70, or directly in the interior of the guide tube 60, until its externally threaded distal end 81 meets the internally threaded nozzle 12 of the balloon 10. The connection tube 80 is then rotated, so as to provide its engagement with the nozzle 12 of the balloon 10. The pull string 17, if used, can be thus extracted from the patient.
Then, the capillary tube 90 can be longitudinally displaced in the interior of the connection tube 80, until its distal end 91, in the form of a tubular needle, is introduced into the balloon 10, through its retention valve 11.
A liquid or gaseous fluid, such as for example, air or gas, can be pumped to the interior or exterior of the balloon 10, through the capillary tube 90, so as to adjust the volume of the balloon 10 to the operational conditions required for the balloon while it is kept in the interior of the stomach cavity of the patient, or to be extracted therefrom in a fully deflated condition.
In case the operation is for adjusting the inflation, the capillary tube 90 is longitudinally displaced, in order to extract its distal end 91 from the interior of the balloon 10 and from the retention valve 11, with the connection tube 80 then being rotated around its axis, so as to allow uncoupling its externally threaded distal end 81 in relation to the internally threaded nozzle 12 of the balloon 10, allowing the latter to remain in the interior of the stomach, with the new inflation adj ustment .
Alternatively, if it is desired to extract the balloon 10, it is fully deflated through the capillary tube 90 and through the fluid pumping device. Next, the connection tube 80, still engaged in the nozzle 12 of the balloon 10, is extracted from the interior of the patient, jointly with the capillary tube 90, the inner tube 70, if existent, and the guide tube 60.
While only one constructive form has been illustrated herein for the present device, it should be understood that the components which form the introduction kit and the withdrawal and inflation-adjustment kit can present configurations other than that illustrated herein, without departing from the inventive concept defined in the claims that accompany the present specification.

Claims

1. A device for treatment of obesity by an intragastric balloon, said device being characterized in that it comprises an introduction kit of the balloon (10), including:
(a) a guide string (20) to be endoscopically introduced into the patient and having an enlarged and flexible distal end (21) positioned in the interior of the patient's stomach, and a free proximal end (22) positioned externally to the patient's mouth;
(b) a tubular guide element (30) slidably mounted around the guide string (20) and carrying a tubular sleeve (32) in a flexible material;
(c) a balloon (10) in an inflatable material and provided with a retention valve (11) which is coupled to an internally threaded nozzle (12) opened to the outside of the balloon (10), which is housed, in a fully deflated condition, in the interior of the tubular sleeve (32);
(d) a fill tube (40), in a flexible material, presenting a distal end (41) provided with an externally threaded axial nozzle (41a) to be engaged in the internally threaded nozzle (12) of the balloon (10); and
(e) a capillary tube (50) longitudinally displaceably disposed in the interior of the fill tube (40) and presenting a distal end (51) introduced in the balloon (10) through its retention valve (11), and a proximal end (52) to be coupled to a fluid pumping device.
2. The device, according to claim 1, characterized in that the tubular guide element (30) carries a conical tip (31), with a tubular configuration, onto which is affixed an end region of the tubular sleeve (32) .
3. The device, according to claim 2, characterized in that the tubular sleeve (32) presents a longitudinal seam (32a) to be ruptured upon expansion of the balloon (10).
4. The device, according to claim 1, characterized in that the distal end (51) of the capillary tube (50) is in the form of a tubular needle.
5. The device, according to claim 1, characterized in that the nozzle (12) of the balloon (10) further carries, externally to the latter, at least one grasping tab (14), in a flexible material and inert to the stomach acids.
6. The device, according to claim 1, characterized in that the balloon (10) carries a permanent magnet (13), presenting an annular shape and concentrically surrounding the nozzle (12) of the balloon (10).
7. The device, according to claim 1, characterized in that the balloon (10) carries an engaging element (15) external to the balloon (10) and disposed in front of the nozzle (12) and axially spaced from the latter.
8. The device, according to claim 7, characterized in that the engaging element (15) comprises at least one grasping loop (15a), in a flexible material and disposed in front of the nozzle (12) of the balloon (10).
9. The device, according to claim 8, characterized in that the engaging element (15) comprises two grasping loops (15a) which are medianly joined to each other in a region located in front of the nozzle 12 and axially spaced from the latter.
10. Device for treatment of obesity by an intragastric balloon, said device being characterized in that it comprises a withdrawal and inflation-adjustment kit of a balloon (10), formed in an inflatable material and which is provided with a retention valve (11) coupled to an internally threaded nozzle (12) opened to the outside of the balloon (10), said kit including:
(i) a guide tube (60), in a flexible material, having a distal end (61) to be approximated to the nozzle (12) of the balloon (10), and an open proximal end (62), to be maintained externally to the patient;
(ii) a connection tube (80), also in a flexible material, displaceably disposed in the interior of the guide tube (60) and presenting an externally threaded distal end (81) to be engaged to the nozzle (12) of the balloon (10), and a proximal end (82) projecting outwardly from the proximal end (62) of the guide tube (60); and
(iii) a capillary tube (90) longitudinally displaceably disposed in the interior of the connection tube (80) and presenting a distal end (81) to be introduced into the balloon (10) through its retention valve (11), and a proximal end (82) to be coupled to a fluid pumping device .
11. The device, according to claim 10, characterized in that the balloon (10) carries a permanent magnet (13) concentrically surrounding the nozzle (12), the distal end (61) of the guide tube (60) carries a permanent magnet ( ) to be seated against the permanent magnet (13) of the nozzle (12) of the balloon (10) .
12. The device, according to claim 11, characterized in that it further comprises an inner tube (70), also in a flexible material, which is longitudinally and slidably disposed in the interior of the guide tube (60) and having an open distal end (71) external to the distal end
(61) of the guide tube (60) and around which is attached the permanent magnet (M) to be seated against the permanent magnet (13) of the nozzle (12) of the balloon
(10), and an open proximal end (72) external to the proximal end (62) of the guide tube (60).
13. The device, according to any of claims 11 or 12, characterized in that the permanent magnet (M) presents a shape for surrounding, concentrically, one of the elements defined by the distal end (61) of the guide tube (60) and the distal end (71) of the inner tube (70).
14. The device, according to claim 10, characterized in that the balloon (10) carries an engaging element (15), external to the balloon (10) , disposed in front of the nozzle (12) and axially spaced from the latter, so that to said engaging element (15) is applied a pull string (17) or an endoscopic clamp.
15. The device, according to claim 14, characterized in that the engaging element (15) comprises at least one grasping loop (15a), in a flexible material and disposed in front of the nozzle (12) of the balloon (10).
16. The device, according to any of claims 10 to 15, characterized in that the distal end (91) of the capillary tube (90) is in the form of a tubular needle.
17. The device, according to any of claims 10 to 16, characterized in that the distal end (61) of the guide tube (60) attaches a support (65), in which is housed and attached a penetrating end portion of an endoscopic instrument .
18. A method for treatment of obesity by an intragastric balloon, using a device comprising the introduction kit, as defined in any of claims 1 to 9, said method being characterized in that it comprises the steps of:
- endoscopically introducing, in a patient, the guide string (20), until its distal end (21) is positioned in the interior of the patient's stomach;
introducing, in the patient, the fill tube (40) carrying the tubular guide element (30), the tubular sleeve (32) and the deflated balloon (10), until the tubular guide element (30), by sliding along the guide string (20), reaches the interior of the patient's stomach;
- filling the balloon (10) with a predetermined quantity of liquid or gaseous fluid, through the capillary tube (50), producing the rupture of the tubular sleeve (32) and the release of the already insufflated balloon (10) from the ruptured tubular sleeve (32);
- withdrawing the guide string (20) carrying, out from the patient, the tubular guide (30) and the ruptured tubular sleeve (32);
- longitudinally displacing the capillary tube (50) until its distal end (51) is withdrawn from the interior of the retention valve (11), allowing the automatic closure of the latter; and
- rotating the fill tube (40) to disengage its externally threaded axial nozzle (41a) from the internally threaded nozzle (12) of the balloon (10), keeping the latter in the interior of the patient's stomach and allowing the withdrawal of the fill tube (40) .
19. A method for treatment of obesity by an intragastric balloon, using a device comprising the withdrawal and inflation-adjustment kit of the intragastric balloon, as defined in any of claims 11 to 13, said method being characterized in that it comprises the steps of:
introducing, in a patient with said balloon (10) already endoscopically positioned and retained in the interior of the stomach, the guide tube (60), until the permanent magnet (M) is seated against the permanent magnet (13) of the nozzle (12) of the balloon (10);
- longitudinally displacing the connection tube (80) in the interior of the guide tube (60) or of the inner tube (70), until its externally threaded distal end (81) meets the nozzle (12) of the balloon (10);
- rotating the connection tube (80), so as to provide the engagement of its distal end (81) to the nozzle (12) of the balloon (10) ;
- longitudinally displacing the capillary tube (90) in the interior of the connection tube (80), until its distal end (91) is introduced into the balloon (10) through its retention valve (11);
- pumping liquid or gaseous fluid to the interior or to the exterior of the balloon (10), through the capillary tube (90), so as to adjust the volume of the balloon (10) to the required operating conditions;
optionally, longitudinally displacing the capillary tube (90) so as to extract its distal end (91) from the interior of the balloon (10) and from the retention valve
(11) , and rotating the connection tube (80), in order to uncouple its distal end (81) in relation to the nozzle
(12) of the balloon (10), for maintaining the latter in the interior of the stomach with the new inflation adjustment; and
- alternatively to the previous step, extracting the withdrawal and inflation-adjustment kit from the interior of the patient, with the balloon (10) in a deflated condition and still engaged to the connection tube (80).
20. Method for treatment of obesity by an intragastric balloon, by using a device comprising the withdrawal and inflation-adjustment kit of the intragastric balloon, as defined in any of claims 14 or 15, said method being characterized in that it comprises the steps of:
- pre-positioning and retaining the balloon (10) already endoscopically positioned and retained in the interior of the patient's stomach, by pulling the pull string (17) or an endoscopic clamp applied to the engaging element (15);
- introducing, in the patient, the guide tube (60) until its distal end (61) is approximated to the nozzle (12) of the balloon (10) ;
- longitudinally displacing the connection tube (80) in the interior of the guide tube (60), until its externally threaded distal end (81) meets the nozzle (12) of the balloon (10);
- rotating the connection tube (80), so as to uncouple its distal end (81) in relation to the nozzle (12) of the balloon (10), so as to maintain the latter in the interior of the stomach, with the new inflation adj ustment .
PCT/BR2010/000331 2009-10-06 2010-08-05 Device and method for treatment of obesity by an intragastric balloon Ceased WO2011041864A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
BRPI0904146-0 2009-10-06
BRPI0904146 2009-10-06
BRPI1001214-1 2010-04-09
BRPI1001214-1A BRPI1001214A2 (en) 2010-04-09 2010-04-09 device and method for treating intra-gastric balloon obesity

Publications (1)

Publication Number Publication Date
WO2011041864A1 true WO2011041864A1 (en) 2011-04-14

Family

ID=43856317

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2010/000331 Ceased WO2011041864A1 (en) 2009-10-06 2010-08-05 Device and method for treatment of obesity by an intragastric balloon

Country Status (1)

Country Link
WO (1) WO2011041864A1 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016046427A1 (en) * 2014-09-26 2016-03-31 Ramon Abad Belando Device for inserting an inflatable balloon
CN107847334A (en) * 2015-06-11 2018-03-27 奥巴隆治疗公司 Intragastric device system
WO2018146547A1 (en) * 2017-02-09 2018-08-16 Spatz FGIA Ltd Check valve with docking station for gastrointestinal balloon
CN108420579A (en) * 2018-03-29 2018-08-21 郑仕诚 Weight-reducing sac in a kind of stomach with remote control valve
US10857019B2 (en) 2012-11-26 2020-12-08 Spatz Fgia, Inc. System and methods for internalization of external components of an adjustable intragastric balloon
CN115916121A (en) * 2020-04-02 2023-04-04 医疗创新发展公司 Deployment device for inflatable intragastric balloon and system for treating obesity in individual comprising such placement device
US11819433B2 (en) 2016-11-04 2023-11-21 Reshape Lifesciences Inc. Pressure control system for intragastric device
US12403026B2 (en) 2018-12-21 2025-09-02 Spatz Fgia, Inc. Valve with docking station for gastrointestinal balloon

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3326061A1 (en) * 1982-07-23 1984-02-02 Otto Dr. med. 2943 Esens Wörner Introduction and filling device for a stomach balloon
US4485805A (en) * 1982-08-24 1984-12-04 Gunther Pacific Limited Of Hong Kong Weight loss device and method
BR0203301A (en) * 2002-08-13 2004-05-18 Bashir Mussa Gazi Improvements introduced for cavity body implants
EP1671590A1 (en) * 2003-09-08 2006-06-21 José Rafael Garza Alvarez Intragastric balloon assembly
WO2008042819A2 (en) * 2006-09-29 2008-04-10 Allergan, Inc. Apparatus and method for intragastric balloon with in situ adjustment means
EP2218475A1 (en) * 2007-11-30 2010-08-18 Sumitomo Bakelite Co., Ltd. Sheath for gastrostoma, dilator provided with sheath, sheath for gastrostoma provided with insertion aid, catheter kit for gastrostoma and method of dividing sheath for gastrostoma

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3326061A1 (en) * 1982-07-23 1984-02-02 Otto Dr. med. 2943 Esens Wörner Introduction and filling device for a stomach balloon
US4485805A (en) * 1982-08-24 1984-12-04 Gunther Pacific Limited Of Hong Kong Weight loss device and method
BR0203301A (en) * 2002-08-13 2004-05-18 Bashir Mussa Gazi Improvements introduced for cavity body implants
EP1671590A1 (en) * 2003-09-08 2006-06-21 José Rafael Garza Alvarez Intragastric balloon assembly
WO2008042819A2 (en) * 2006-09-29 2008-04-10 Allergan, Inc. Apparatus and method for intragastric balloon with in situ adjustment means
EP2218475A1 (en) * 2007-11-30 2010-08-18 Sumitomo Bakelite Co., Ltd. Sheath for gastrostoma, dilator provided with sheath, sheath for gastrostoma provided with insertion aid, catheter kit for gastrostoma and method of dividing sheath for gastrostoma

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10857019B2 (en) 2012-11-26 2020-12-08 Spatz Fgia, Inc. System and methods for internalization of external components of an adjustable intragastric balloon
WO2016046427A1 (en) * 2014-09-26 2016-03-31 Ramon Abad Belando Device for inserting an inflatable balloon
US10537457B2 (en) 2014-09-26 2020-01-21 Ramon Abad Belando Device for inserting an inflatable balloon
EP3307213A4 (en) * 2015-06-11 2019-01-09 Obalon Therapeutics, Inc. INTRAGASTRIC DEVICE SYSTEM
US10617545B2 (en) 2015-06-11 2020-04-14 Obalon Therapeutics, Inc. Intragastric device system
CN107847334B (en) * 2015-06-11 2020-08-21 奥巴隆治疗公司 Intragastric device system
CN107847334A (en) * 2015-06-11 2018-03-27 奥巴隆治疗公司 Intragastric device system
US11819433B2 (en) 2016-11-04 2023-11-21 Reshape Lifesciences Inc. Pressure control system for intragastric device
US12440358B2 (en) 2016-11-04 2025-10-14 Reshape Lifesciences Inc. Pressure control system for intragastric device
WO2018146547A1 (en) * 2017-02-09 2018-08-16 Spatz FGIA Ltd Check valve with docking station for gastrointestinal balloon
US10893966B2 (en) 2017-02-09 2021-01-19 Spatz FGIA Ltd Check valve with docking station for gastrointestinal balloon
US12167976B2 (en) 2017-02-09 2024-12-17 Spatz Fgia, Inc. Check valve with docking station for gastrointestinal balloon
CN108420579A (en) * 2018-03-29 2018-08-21 郑仕诚 Weight-reducing sac in a kind of stomach with remote control valve
US12403026B2 (en) 2018-12-21 2025-09-02 Spatz Fgia, Inc. Valve with docking station for gastrointestinal balloon
CN115916121A (en) * 2020-04-02 2023-04-04 医疗创新发展公司 Deployment device for inflatable intragastric balloon and system for treating obesity in individual comprising such placement device
US20230147124A1 (en) * 2020-04-02 2023-05-11 Medical Innovation Developpement Placement device for an inflatable intra-gastric balloon system for treating obesity in an individual comprising such a placement device

Similar Documents

Publication Publication Date Title
WO2011041864A1 (en) Device and method for treatment of obesity by an intragastric balloon
TW568766B (en) An implantable surgical staple, a surgical treatment device, urinary incontinence treatment apparatus and apparatus for implanting a staple into a patient
RU2604042C2 (en) Dilation device for placing catheter tubes
JP5079814B2 (en) Device and method for intragastric balloon with adjusting means
US11253260B2 (en) Methods for diagnosing and delivering therapeutic interventions in the peritoneal cavity
US6837871B2 (en) Self-deploying catheter assembly
US8048062B2 (en) Catheter assembly and method for internally anchoring a catheter in a patient
US20090112183A1 (en) Medical devices and methods of use
US20070135825A1 (en) Methods and devices for anchoring to tissue
CN107155301A (en) Can connecting conduit
US9901473B2 (en) Artificial sphincter and intragastric suspended balloon
US20070016172A1 (en) Ostomy tube device, ostomy placement kit and method for an ostomy tube placement
WO2013026474A1 (en) Devices and methods for anchoring an endoluminal sleeve in the gi tract
CN102639069A (en) Urethral anastomosis device
JP3347315B1 (en) Gastrostomy catheter kit
EP2023828A2 (en) Methods and devices for anchoring to soft tissue
US10238392B2 (en) Methods for diagnosing and delivering therapeutic interventions in the peritoneal cavity
JP5031201B2 (en) Fluid adjustable band
US20200030129A1 (en) Methods and apparatus for anchoring a gastrointestinal implant
BRPI1001214A2 (en) device and method for treating intra-gastric balloon obesity
US20240173156A1 (en) Gastro-intestinal tube and anchoring therefor
BR102020019578A2 (en) Devices and method for bidirectional adjustment of intragastric balloons and block valve
US20240050254A1 (en) Devices and method for bi-directional adjustment of intragastric balloons, and shut-off valve
BR102020017878A2 (en) Devices and method for bidirectional adjustment of intragastric balloons
CN101668489B (en) Connecting devices for performing endoluminal and/or transluminal surgery

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 10821498

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 10821498

Country of ref document: EP

Kind code of ref document: A1