Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/005—Gastric bands
  • A61F5/0066—Closing devices for gastric bands
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
  • A61F5/0013—Implantable devices or invasive measures
  • A61F5/005—Gastric bands
  • A61F5/0053—Gastric bands remotely adjustable
  • A61F5/0056—Gastric bands remotely adjustable using injection ports

Definitions

• the invention relates to the technical field of devices intended to be implanted at the level of the connection zone, between the abdominal part of the esophagus and the stomach, in order to create a local restriction allowing a control of the quantity of food ingested by the patient carrying the device.
• the inflatable gastric band comprises an elongate flat tubular body of flexible material which is at least partly elastically deformable and which defines an inflatable airtight chamber for presenting a working face intended to be placed in contact with stomach, and a back opposite of the working side.
• the gastric band also comprises connecting means equipping the ends of the tubular body and for closing the gastric belt in the form of a ring, the working face being, of course , facing inwards.
• the gastric band also comprises an inflation catheter sealingly connected to the inflatable chamber and intended to be connected to inflation means.
• the inflation means may be, for example, constituted by a housing provided with a self-sealing membrane which can be pierced by a syringe needle or the like, by means of which an injection or a sample of fluid, such as, for example, For example, but not necessarily, physiological saline can be performed to control the swelling of the chamber and thus the dimensions of the stomach constriction achieved by means of the inflatable gastric band.
• an inflatable gastric band comprising:
• An elongated tubular body of flexible material which is at least partly elastically deformable, which defines an inflatable airtight chamber and which has a back and a working face,
• Connecting means arranged in relation to both ends of the tubular body and for closing the gastric belt in the form of a ring, the working face being disposed inside the ring,
• an inflation catheter for connection to inflation means and sealingly connected to the inflatable chamber via an inflation port provided in the back of the body or at an end of the elongate tubular body.
• the inflatable gastric band is characterized in that the elongate tubular body is preformed to present, at rest and before closure of the belt, a longitudinal section having a general shape in "C".
• the "C" preform of the tubular body substantially facilitates the establishment and closure of the gastric band, particularly during laparoscopic implantation, since it is no longer necessary to maintain the two ends of the tubular body to initiate ring setting.
• the tubular body extends, at rest and before closing the belt, on an angular sector between 160 ° and 300 ° and preferably between 250 ° and 280 °. He has indeed It has been found that these values are particularly adapted to the anatomical characteristics of the part of the stomach where the gastric band is implanted and greatly facilitate the operation of closing the belt. This preformation avoids errors in the direction of engagement of the band behind the stomach because considering the preform C it is impossible to close the belt with the working face outside.
• the working face of the inflatable tubular body has, at rest and before closure of the belt, a radius of curvature. between 22 mm and 35 mm and preferably between 22 mm and 30 mm, and more preferably between 22 mm and 29 mm.
• the working face of the inflatable tubular body has a developed length of between 110 mm and 130 mm and preferably between 112 mm and 117 mm or between 123 mm and 127 mm.
• the inflatable tubular body has, at rest and before closure of the belt, in a central region a cross section rectangular or oblong.
• the working face of the inflatable tubular body has the shape of a portion of a cylinder ring.
• the connecting means for ensuring a closure of the ring belt can be made in any appropriate manner.
• the connecting means comprise, on the one hand, at a first end of the body, called inflation, a connection tail of the catheter to the inflatable chamber and, secondly, near the opposite end, said head, at least one hoop arranged on the back of the body for the passage of the connecting tail.
• At least part of the connecting tail has, at rest and before closing the belt, a curved shape in the extension of the bending of the tubular body.
• the bent part of the connecting tail extends over an angular sector between 45 ° and 75 ° and preferably between 50 ° and 60 °.
• the connecting tail comprises a proximal curved portion and a distal rectilinear portion which extends in the extension of the curved portion in a direction tangent to the curvature of the arched part.
• the edges of the tubular body connecting the inflation end to the connecting tail have a shape in "S" flattened to define a connection area without projecting angles.
• the locking of the gastric band ring can be achieved in different ways.
• the connecting tail has at least one fir-shaped locking configuration comprising two generally V-shaped returns which are arranged either side of the connecting tail being oriented towards the tubular body and whose two main sides form an angle less than or equal to 45 °.
• the presence of its two V-shaped returns gives each fir conformation a shape of arrow or lanceolate.
• the gastric band comprises at least two conformations of fir-shaped lock, a first so-called proximal locking conformation extending over the proximal curved portion of the connecting tail and a second so-called distal locking conformation extending over the distal rectilinear portion of the connecting tail.
• the latter preferably comprises, at the level of the back of the tubular body, as many hoops that the connecting tail comprises fir-shaped locking conformations, each hoop comprising two notches or two sails locking "V" returns of the corresponding locking conformation.
• each arch defines a tunnel for receiving the connecting tail, the inner wall of the tunnel converging opposite the head of the tubular body and the portion of the connecting tail, intended to be placed in the tunnel defined by the hoop in the closed position of the belt, has a complementary shape.
• the complementarity of the forms reinforces the locking and, moreover, also avoids the development of tissues between the retardation tail and the arch or arches that overlap it.
• the inflatable tubular belt can be made in different ways.
• the tubular body and the connecting tail form a one-piece assembly obtained by injection molding into an arcuate recess. The free end of the body may then be closed or formed by an attached plug.
• the belt comprises at least one opaque radio-opaque wire embedded in a wall of the inflatable tubular body.
• the opaque material wire may be incorporated alone into one or other of the walls of the inflatable tubular body or else be incorporated in an inextensible flexible reinforcing strip integrated into the back of the inflatable tubular body.
• the latter will be made of an opaque radio material comprising gold.
• the inflatable gastric band may be made of any suitable biocompatible material and preferably made of biocompatible silicone of gray or matte color so as to have a non-dazzling external surface when it is illuminated and observed by means of a device of celoscopy.
• Fig. 1 is a perspective in a state of rest of a gastric band according to the invention.
• Fig. 2 is a side elevation view from the head end of the inflatable tubular body of the gastric band illustrated in FIG. 1.
• the fg. 3 is an elevation in side view from the connecting end of the inflatable tubular body of the gastric band illustrated in FIG. 1.
• Fig. 4 is a longitudinal section along plane IV-IV of FIG. 3 of the gastric belt.
• Fig. 5 is a cross section along the line V-V of FIG. 4.
• Fig. 6 is a detail view of an arch of the gastric belt along the line VI-VI of FIG. 2.
• a gastric belt according to the invention illustrated in FIGS. 1 to 4 and generally designated 1, comprises a tubular body 2 which defines at least one inflatable sealed chamber 3. According to the invention, the body 2 has, in elevation in plan view, a general shape C.
• the body 2 has a generally flat shape and a transverse cross section , as more particularly illustrated in FIG. 5, substantially rectangular or oblong, the inflatable chamber 3 having a transverse cross section of general shape also forming a rectangle.
• the gastric belt 1 then has a back 4 and a working face 5 intended to come into contact with the esophageal or stomach zone, at which the belt will be placed, as will be apparent from the following.
• the general C shape of the inflatable tubular body 2 confers on the longitudinal cross-section of the body 2, as more particularly illustrated in FIG. 4, a C shape which extends over an angular sector whose central angle ⁇ has a value between 160 ° and 300 ° and preferably between 250 ° and 280 °, the angle is also likely to take as value one or the other of the limits of these different intervals.
• the working face 5 of the body 2 then has the shape of a cylinder panel portion having a constant radius of curvature R between 22 mm and 35 mm and preferably between 22 mm and 30 mm and, more particularly preferably, between 22 mm and 29 mm, the radius of curvature R being able to also take as value one or the other of the terminals of these different intervals.
• the working face of the inflatable tubular body 2 has a developed length of between 110 mm and 130 mm and preferably between 112 mm and 117 mm or between 123 mm and 127 mm, the latter two intervals corresponding to two distinct sizes. gastric belt according to the invention.
• the belt 1 also comprises connecting means 10 and 11 fitted to both ends of the belt.
• the connecting means 10 and 11 may be made in any suitable manner.
• the connecting means 10 comprise, first of all, at a first end 12 of the inflation body 2, a connecting tail 13 of a catheter 14 to the inflatable chamber 3.
• the connecting tail 13 then extends substantially in the longitudinal extension of the body 2 and has an internal channel 15 connected to the chamber 3 by an inflation orifice 16, as shown more particularly in FIG. 5.
• this channel 15 communicates with the inner conduit 17 of the catheter 14 which is then connected to the chamber 3, via the inflation orifice 16.
• the connecting tail 13 has, at rest and before closing the belt , a curved shape that extends in the extension of the bending of the body 2.
• This curved shape may extend over all or part of the length of the connecting tail 13.
• this arched shape does not interest a portion 18p, said proximal, of the connecting tail extending between the inflating end 12 and a central region of the connecting tail 13.
• the curved proximal portion 18p extends over an angular sector of which the angle at the center ⁇ and between 45 ° and 75 ° and preferably between 50 ° and 60 °, the angle ⁇ is also likely to take as one of the values of these different intervals.
• the proximal portion 18p is extended by a rectilinear distal portion 18d which extends in a direction tangent to the curvature of the curved portion 18p.
• the connecting means 11, located at or near the end opposite the inflation end 12 and said free end 19, are, according to the illustrated example, constituted by at least one and, in the here, two arches 20, 21 arranged at the back 4 of the body 2 and intended to receive the tail 13.
• the two hoops 20, 21 are located at a distance from each other and the shank 13 comprises means 22 for locking or non-return intended to prevent any inadvertent withdrawal of the connecting tail 13 after engagement of the latter in the arches 20, 21.
• the non-return locking means comprise two conformations 22 proximal and distal spruce which are each intended to cooperate with a bow 20, 21 corresponding.
• the first locking conformation or locking conformation is arranged on the so-called proximal bent portion 18p of the connecting tail while the second locking conformation or distal locking conformation extends on the distal portion 18d of the tail connection.
• Each locking conformation 22 comprises two generally V-shaped returns 23 which are disposed on either side of the connecting tail while being oriented towards the tubular body 2.
• the returns 23 are arranged so as to be substantially parallel or tangential to the generating cylinder of the surface of the working face 5 of the inflatable tubular body 2.
• the first arch 20 or proximal arch has blanks that extend towards the second arch 21 so as to define a fingerprint 26 for total or partial reception of the locking conformation 22 closest to the end 12 body 2, called proximal.
• the arch 20 further comprises two webs under which the returns 23 of the proximal locking conformation 22 placed in the cavity are engaged.
• the second arch 21 comprises at its connecting legs with the back 4 of the body 2 two notches 28 in which the returns 23 of the second locking conformation come to lock when the gastric belt 1 is closed in a ring.
• the wall of each notch 28 forms, as shown in FIG. 4, with the back 4 of the belt an acute angle.
• the inner main 24 of each return 23 then forms, as shown in FIG. 1, with the lower face of the locking conformation an obtuse angle complementary to the acute angle of the notches 28. This complementarity of form guarantees the effectiveness of the locking.
• each arch 20, 21 defines a tunnel for receiving the connecting tail 13 whose inner wall converges opposite the head 19 of the body 2 as shown more particularly in FIGS. 1 and 6.
• Fir conformations 22 block the sliding of the locking tail 13 in the opposite direction.
• the free end 32 of the catheter 14 is closed by a plug 33, of conical shape, which prevents the introduction of materials into the catheter channel and facilitates the introduction of the catheter into the arch 20 during closure of the belt.
• the plug 33 will be cut after closure of the belt, for the establishment of the inflation means 34.
• the inflatable gastric band 1 can be made of any suitable biocompatible material, such as, for example, biocompatible silicone or implantable grade, which gives the body 2 the flexibility and elasticity necessary for the inflation of the chamber 3.
• the biocompatible silicone used will be tinted to have a gray color so as to provide a non-dazzling outer surface when illuminated and observed by means of a laparoscopic device. This non-glare character can also be achieved by imparting a matte appearance to the outer surface of the gastric band 1.
• the connecting means 10, 11 are then implemented to ring the inflatable belt 1, as shown in FIG. 4.
• a band reinforcements 40 flexible, inextensible in order to ensure better control of the stomach restriction formed by the belt 1, it is also planned to incorporate, in the wall of the body 2 constituting the back 4, a band reinforcements 40 flexible, inextensible.
• the flexible reinforcing strip 40 may be made of any suitable inextensible flexible material, such as, for example but not exclusively, a dacron fabric.
• the armature 40 is completely embedded in the wall of the body 2 forming the back 4 and is completely surrounded by the material constituting the body 2.
• an opaque radio wire 41 such as a gold wire, is incorporated in the body 2 and preferably in the back of the latter .
• the opaque radio wire 41 may then be either independent of the reinforcing strip 40, or may be an integral part of the latter.
• the edges 42 of the tubular body 2 connecting the inflation end 12 to the connecting tail have a flattened "S" shape so as to define a connection zone without projecting angle.
• This form of the connection region between the body 2 and the connecting tail 13 facilitates the penetration of the gastric band into the tissues and / or the fat masses surrounding the stomach during the implantation of the gastric band according to the invention. .

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• 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)
• Materials For Medical Uses (AREA)

Applications Claiming Priority (3)

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• 2006
  • 2006-10-30 FR FR0609494A patent/FR2903298B3/fr not_active Expired - Fee Related
• 2007
  • 2007-07-05 WO PCT/FR2007/001139 patent/WO2008003862A2/fr active Application Filing
  • 2007-07-05 US US12/309,023 patent/US20090240269A1/en not_active Abandoned
  • 2007-07-05 BR BRPI0713273-5A patent/BRPI0713273A2/pt not_active IP Right Cessation
  • 2007-07-05 MX MX2009000101A patent/MX2009000101A/es not_active Application Discontinuation
  • 2007-07-05 AU AU2007271014A patent/AU2007271014A1/en not_active Abandoned
  • 2007-07-05 CA CA002656345A patent/CA2656345A1/fr not_active Abandoned
  • 2007-07-05 EP EP07803844A patent/EP2034931A2/de not_active Withdrawn

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