WO2011071834A1 - Bandage gastrique assorti des caractéristiques de prévention de glissement - Google Patents

Bandage gastrique assorti des caractéristiques de prévention de glissement Download PDF

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Publication number
WO2011071834A1
WO2011071834A1 PCT/US2010/059128 US2010059128W WO2011071834A1 WO 2011071834 A1 WO2011071834 A1 WO 2011071834A1 US 2010059128 W US2010059128 W US 2010059128W WO 2011071834 A1 WO2011071834 A1 WO 2011071834A1
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WO
WIPO (PCT)
Prior art keywords
band
stomach
gastric
attachment
implantable
Prior art date
Application number
PCT/US2010/059128
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English (en)
Inventor
Paul Super
Original Assignee
Paul Super
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Paul Super filed Critical Paul Super
Publication of WO2011071834A1 publication Critical patent/WO2011071834A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A61F5/0056—Gastric bands remotely adjustable using injection ports
    • 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
    • A61F5/005—Gastric bands
    • A61F5/0063—Gastric bands wrapping the stomach

Definitions

  • the present invention relates, in general, to devices and methods for controlling obesity, and, more particularly, to a gastric band directed at reducing the incidence of pouch dilation and gastric prolapse.
  • a hollow band i.e., a gastric band
  • a gastric band made of silicone elastomer
  • the band is then inflated with a saline solution by using a non-coring needle and syringe to access a small port that is placed under the skin.
  • the gastric band can be tightened or loosened over time by the physician or another technician extracorporeally by increasing or decreasing the amount of saline solution in the band via the access port to change the size of the passage or stoma .
  • Gastric prolapse also known as a "slipped band" occurs when a part of the stomach below an implanted band herniates cephalad through the band. The herniated portion fills with saliva and ingested materials, becomes engorged and is pulled downward by gravity. Eventually, the engorged portion of the stomach dilates, resulting in a partial, and ultimately complete, gastric obstruction below the gastroesophageal junction and above the band.
  • the treatment of gastric prolapse includes hospital admission and the operative repositioning of the band.
  • a phenomenon of pouch dilation usually occurs, resulting in a failure of the device. If pouch dilation progresses then slippage may subsequently result.
  • prevention of slippage will in turn prevent the most common cause of gastric band erosion whereby a portion of the band ulcerates through the gastric wall and enters the lumen of the stomach.
  • a implantable system for example, a gastric band system.
  • the system generally includes
  • an implantable band including an inner surface for substantially circumscribing at least a portion of the
  • the band includes an inflatable portion for enabling adjustment of a stoma size via a fluid access port and fluid line.
  • the system further comprises a flexible attachment assembly secured onto the inner surface of the band by means of adhesive or other suitable means.
  • the attachment assembly may be structured to hold the band in place on the stomach without causing injury thereto.
  • the attachment assembly is structured to reduce the chance of gastric wall prolapse, stomach pouch dilatation and band
  • the attachment assembly includes a first member, or first portion, extending in a first direction substantially perpendicular to a longitudinal axis of the band, and a second portion extending in a second direction
  • the first portion may extend laterally away from the inflatable portion of the band and in a generally upward direction when the band circumscribes an organ, for example, a stomach, of a patient.
  • the second portion may extend laterally away from the inflatable portion and in a downward direction when the band circumscribes the organ, for example, stomach, of a patient.
  • the first portion is sized and/or shaped differently than the second portion.
  • the first portion extends in the first direction a greater distance than the second portion extends in the second direction.
  • the first portion is sized, shaped or configured to substantially conform to the contours of the stomach surfaces above the band when the band encircles the stomach to form a stoma.
  • the first portion may be structured, for example, may have a suitable elasticity, so as to provide gentle constriction on the stomach pouch to reduce the chance of pouch dilation.
  • the first portion is sized to cover the anterior surface of the cardia above the band when the gastric band is implanted onto the stomach.
  • the second portion may be sized and or shaped to at least partially circumscribe a lower surface of the stomach below the band when the band is positioned on the stomach to form a stoma.
  • the gastric band and attachment assembly are sized and structured so that the system is substantially entirely laparoscopically implantable in a patient, for example, using standard laparoscopic techniques.
  • the attachment assembly is flexible such that it can be rolled or folded into a narrow configuration, for
  • methods for implanting a gastric band system in a patient are provided.
  • the method may comprise the steps of providing an adjustable gastric band of the invention such as described herein, rolling the attachment member into a narrow configuration adjacent to the gastric band, positioning the gastric band and rolled attachment assembly in a standard laparoscopic tool for insertion through a standard laparoscopic port and delivering the gastric band around the stomach and fastening the band around the stomach using standard surgical techniques.
  • the method may further comprise the step of suturing the attachment member to a non- stomach surface, for example the hiatus and crura.
  • FIG. 1 is a simplified drawing of gastric prolapse of a stomach after conventional gastric banding, also known as a "slipped band";
  • FIG. 2 is another simplified drawing of a more advanced stage of the gastric prolapsed shown in Fig. 1, with rotation of the gastric band downward;
  • FIG. 3 is a plan view of a PRIOR ART inflatable gastric band
  • Fig. 5 is a plan view of an inflatable gastric band of the present invention
  • Fig 5A is a simplified drawing of the gastric band shown in Fig. 5 after it has been buckled around the stomach to form a stoma and an upper stomach pouch.
  • FIG. 6 shows suitable positioning of cannulas for laparoscopic implantation of the present invention.
  • FIG. 7 is a simplified drawing of a traditional gastric band (without slip prevention features) after it has been secured in place on a stomach using traditional gastro- gastro suture fixation methods.
  • gastric prolapse also known as a "slipped band" sometimes occurs when a part of the stomach 2 below an implanted, conventional gastric band 4 herniates cephalad through the band 4.
  • the herniated portion 5 of the stomach 2 is frequently the fundus, although any portion of the stomach 2 adjacent the band 4 may be involved.
  • the herniated portion 5 fills with saliva and ingested materials, it becomes engorged as it is pulled by gravity.
  • the slipped portion 5 of the stomach dilates and causes the band 4 to slip and rotate downward, as shown in Fig. 2.
  • the result is a partial and ultimately complete, gastric obstruction below the gastroesophogeal junction 7 and above the band 4.
  • an implantable system wherein the system generally comprises an implantable band including an inner surface for substantially circumscribing at least a portion of the gastrointestinal tract of a mammal.
  • the implantable system is an implantable gastric band system for restricting by substantially or entirely circumscribing an upper portion of the stomach of a human being.
  • the present invention provides a gastric band or gastric band system that incorporates features for preventing, or at least substantially reducing the chance of pouch dilation, gastric wall prolapse and band slippage.
  • the gastric band includes one or more flexible members in contact with the upper surfaces of the stomach, such as the cardia region. When in contact with the stomach surface, the members facilitate holding the band in place.
  • the members are designed to prevent, or at least reduce the chance of, slippage of the implanted band.
  • the members are of a suitable material that is preferably well tolerated in the body and does not cause substantial adverse effects on the stomach tissues.
  • a number of different gastric bands are available today, and the present invention may be incorporated as a feature of such bands, including those not yet available on the market.
  • a preferred gastric band for use is sold under the name LAP-BAND ® Adjustable Gastric Banding System (LAGB) by Allergan, Inc. of Irvine, CA, and is designed to be placed laparoscopically (via small incisions in the abdomen, usually 0.5 - 1.5 centimeters in length) .
  • An inflatable band is placed around the top portion of the patient's stomach, creating a small pouch that limits or reduces food consumption.
  • the LAP- BAN 0® System is adjustable, which means that the inflatable band can be tightened or loosened to help the patient achieve a level of satiety while maintaining a healthy diet, supporting a patient's long-term weight loss success.
  • Other possible gastric bands are adjustable electromechanically without hydraulics, and still others may have a fixed-size with no adjustment.
  • a conventional LAP-BAND® gastric band 4 is shown in Fig. 3.
  • the band 4 includes an inflatable portion 8 which is connected by fluid line 9 to a fluid access port (not shown) for enabling adjustment of the size of the stoma opening by
  • System 110 includes a band 120 and a first attachment member 122 extending laterally therefrom and sized, shaped and positioned to
  • system 110 includes a second attachment member 124 extending laterally therefrom and sized and shaped to
  • the first attachment member 122 is sized and/or shaped differently than the second attachment member 124 in order to accommodate the different configuration and contours of the stomach above and below the band 120.
  • the first attachment member 122 may be contoured to closely match the contour of the stomach surface above the band 120.
  • the first attachment member 122 may be somewhat conical in shape when the band 120 is locked in the circular configuration.
  • the first attachment member 122 may include a wide proximal portion 134 and a
  • the first attachment member 122 is structured to prevent, or substantially prevent, dilation of the stomach pouch 30, for example, by providing a gentle restriction around the cardia, or other portion of the stomach pouch 30.
  • the first attachment member 122 extends in the first direction a greater distance than the second attachment member 124 extends in the second direction.
  • the first portion may be sized and shaped so as to prevent pouch dilation by surrounding or substantially surrounding the upper portion of the stomach or stoma and providing gentle restriction thereto.
  • the attachment members 122 and 124 are generally made of a biocompatible material, and preferably comprise a material that inhibits tissue erosion when positioned on the stomach tissues for an extended period of time.
  • the attachment members 122, 124 may comprise of soft, highly flexible mesh or other porous material, or other suitable flexible material that can move with the dynamic movements of the stomach without causing injury thereto.
  • the material preferably has a thickness and/or durometer that allow the material to be rolled or folded and thereafter inserted into a cannula of a laparoscopic instrument used to implant a
  • the material may be soft and pliable rather than rigid and unyielding.
  • the material may be comprised of polyethylene terepthalate, polyester, cotton, polyurethane, expanded polytetrafluoroethylene (ePTFE) , silicon, or various polymers or fibers and have any suitable form, such as a fabric, mesh, textured weave, felt, looped or porous structure.
  • the attachment members (122, 124) may be in the form of a mesh or thin solid sheet.
  • the mesh may be made of single filaments, multifilament materials or a thin sheet of solid polymer with or without perforations.
  • Mesh materials useful in the present invention can be produced by knitting, weaving, braiding, or otherwise forming a plurality of yarns into a mesh, or a thin solid polymer sheet can be produced in a mould in variations of the invention where a mesh is not utilised.
  • the material is a thin sheet of silicon elastomer with 5mm perforations , each being 5mm apart.
  • implantation of the presently described gastric band system may be performed without substantial modification to conventional laparoscopic techniques .
  • Methods of the present invention include positioning the above described and shown inventive gastric band on a stomach using laparoscopic techniques and suturing the
  • the band 120 is held in place by suturing the mesh using three sutures through the mesh and into tissue, for example but not limited to, the anterior hiatal margin and respective right and left crura.
  • tissue for example but not limited to, the anterior hiatal margin and respective right and left crura.
  • a plication suture of the fundus is performed and sutured to the left crus, thus creating a sutured gastropexy to the left crus at 150 ("the Birmingham stitch") This suture is not shown in fig.5A.
  • the method comprises the steps of providing an implantable band system, for example of system 110, and placing the band system in a mammal, for example, a human being, using conventional surgical techniques.
  • the method results in a reduced occurrence of gastric band slippage relative to an otherwise identical gastric band without the attachment
  • This Example describes a procedure for placing the present gastric band, such as the band system 110 shown in Fig. 5, using conventional laparoscopic techniques.
  • the patient is in a supine position with the arms extended, legs apart, and all extremities well-padded.
  • An orogastric tube is used for gastric decompression.
  • the surgeon stands between the patient's legs, the first assistant stands on the patient's left, and the monitors are placed at the head of the table.
  • Several tenets of laparoscopy are followed to
  • a five-port technique is used: three 5-mm ports, one 15-mm port, and one 12 -mm Optiview (Ethicon Endo-Surgery,
  • a 5-mm trocar is placed laterally at the right and left subcostal margins, a 15-mm port (US Surgical Corporation, Norwalk, Connecticut) just to the right of the midline half way between the xiphoid process and the umbilicus, and the Optiview in the left mid clavicular subcostal margin. Widely placed trocars allow each instrument to be moved more freely.
  • the long instruments include atraumatic graspers, an electrocautery hook, needle drivers, a suction irrigator, and endoshears. Abdominal access is obtained under direct vision by using the Optiview trocar with a 10 -mm 0-degree laparoscope placed under the left costal margin. Once the peritoneal cavity is entered, an exchange is made to a 10 -mm, 30-degree
  • the first step is elevation and retraction of the liver .
  • the Nathanson liver retractor (Cook, Bloomington, Indiana) is a fixed, curved retractor that is attached to a self- retaining mechanical arm of the surgeon's choice. An entry point is made with a 5-mm port just below the xiphoid process. The port is then removed, and the Nathanson liver retractor is inserted. All adhesions from previous open cholecystectomy procedures are divided before this instrument is inserted so that the liver can be lifted properly. If the liver is very large and heavy, a long grasper placed through the right
  • subcostal port can be used to elevate the front edge of the liver so that the Nathanson liver retractor can pass behind it.
  • the aim of liver retraction is to elevate the liver away from the gastroesophageal angle and spleen, which allows safe
  • the curve of the Nathanson liver retractor should lie under the broadest part of the liver to allow broad-based elevation. This maneuver reduces the chance of liver injury. A huge fatty liver and a heavy cirrhotic liver are both very difficult to lift. In these two situations, help is required from the long grasper coming in from the right side.
  • liver retraction is retraction of the gastric fundus to expose the angle of His.
  • the omentum is not grasped because it almost always bleeds, and grasping the omentum tends to place traction on the spleen.
  • a sweeping maneuver is preferred.
  • a long grasper (closed)
  • gastroesophageal junction and continues onto the peritoneum just above the fundus, but not as low as the first short gastric vessel. Any attachments between the fundus and diaphragm are divided. This dissection allows the gastric fundus to be pushed gently caudad for full mobilization of the angle of His.
  • the stomach is covered with perigastric fat localized in several predictable collections, or "pads.” These are prevalent in male patients and in diabetics. If very large the fat pads are present around the gastroesophageal junction then these may require to be excised.
  • Complete excision of the fat pads may be necessary to (1) facilitate performing the operation, (2) minimize the risk for postoperative esophageal obstruction, and (3) visualize the stomach to ensure correct band placement position and at the same time the hiatus may be inspected to detect any co-existing hiatus hernia which must be repaired if found .
  • a superficial anterior fat pad is found at the angle of His. Often, other large lipomas curve around the gastroesophageal junction posterolaterally and up toward the esophageal hiatus. In super-obese men, perigastric fat can be very thick at the lesser curve, behind the lesser omentum, and anterior to the right crus . These are gently retracted and divided .
  • the medial fat pads can be technically challenging to remove because of their vascularity.
  • Various methods can be technically challenging to remove because of their vascularity.
  • the third step is division of the lesser omentum.
  • the pars flaccida is almost transparent over the caudate lobe and easily divided.
  • the technical risk here is a left hepatic artery rising from the left gastric artery. If a large hepatic artery is coming off the left gastric artery, a two-step procedure is used. This involves creating a perigastric dissection at the same level as the pars flaccida dissection and then feeding the tubing medially between the left hepatic artery and the
  • the fourth step is identification of the most inferior aspect of the right crus as it disappears into the retroperitoneal fat.
  • the point of dissection is where the right crus disappears into the retroperitoneal fat.
  • the peritoneum of the right crus just medial to the right crus is incised.
  • the long grasper comes through the right lateral port and passes gently into this area of dissection without any torque. It then passes for a very short distance behind the gastroesophogeal junction to emerge into the already dissected angle of His.
  • the retro-gastric dissection may be performed one tissue layer more posteriorly beneath the thin muscle sheath covering both crura. Once the grasper comes through the pars flaccida tunnel, it is ready to grasp the band by its tubing to pull it through, or in some band designs to grasp the thread attached to the band closure mechanism.
  • the gastric band of the invention for example, band 120 including the attachment members 122, 124 in a rolled configuration along the axis of the band 120, is inserted into the abdomen through the 15-mm trocar. Using this trocar prevents injury to the delicate inner lumen of the band. After the band is inside the abdomen, the tubing is grasped by the retrogastric grasper and pulled around the stomach.
  • band 120 including the attachment members 122, 124 in a rolled configuration along the axis of the band 120
  • retroperitoneal tissue typically snags on the shoulder of the band and must be freed separately to allow the band to rotate freely. Once this is done, the band slides easily.
  • the tubing tag is fed through the locking mechanism of the band, and the band is locked.
  • the locked band should not be tight on the stomach but rather should be able to rotate freely around the upper stomach. If the band appears snug or does not rotate easily, fluid should be aspirated from the band system or a larger band utilized. Alternatively more perigastric fat can be excised .
  • the first of the attachment members for example, portion 122 is sutured using three or more sutures through the members.
  • the upper portion 122 of the mesh is sutured into the hiatus and each respective crura, not into the stomach.
  • the lower portion 124 of the mesh is not sutured to tissue .
  • the band is already secured posteriorly by its retro- gastric tunnel through the retroperitoneal and gastro-esophageal attachments .
  • the inner diameter of the band 120 is calibrated for the first time with saline injection into the access port. Additional calibrations are later

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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)

Abstract

L'invention porte sur un système de bandage gastrique (110) comprenant un ensemble de fixation. Le système comprend un bandage gastrique gonflable (120) et un élément de maillage souple ou de feuille polymère perforée (122, 124) s'étendant latéralement loin de la partie gonflable du bandage. Le système est conçu pour empêcher ou réduire l'incidence du glissement du bandage lorsqu'il est implanté chez un patient.
PCT/US2010/059128 2009-12-08 2010-12-06 Bandage gastrique assorti des caractéristiques de prévention de glissement WO2011071834A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26775409P 2009-12-08 2009-12-08
US61/267,754 2009-12-08

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WO2011071834A1 true WO2011071834A1 (fr) 2011-06-16

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2559410A1 (fr) * 2011-08-18 2013-02-20 A.M.I. Agency for Medical Innovations GmbH Dispositif de traitement de l'obésité

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0769282A1 (fr) * 1995-09-22 1997-04-23 Kirk Promotions Limited Dispositif pour la réduction de nourriture d'un patient et l'utilisation dudit dispositif
US5910149A (en) * 1998-04-29 1999-06-08 Kuzmak; Lubomyr I. Non-slipping gastric band
EP0923356B1 (fr) * 1997-06-09 2002-09-04 Arnold Pier Sangle gastrique inserable par laparoscopie
US20050119674A1 (en) * 2003-10-23 2005-06-02 Peter Gingras Gastric constriction device
US20060015151A1 (en) * 2003-03-14 2006-01-19 Aldrich William N Method of using endoscopic truncal vagoscopy with gastric bypass, gastric banding and other procedures
US20090157107A1 (en) * 2006-08-21 2009-06-18 A.M.I. Agency For Medical Innovations Gmbh Device for the treatment of obesity

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0769282A1 (fr) * 1995-09-22 1997-04-23 Kirk Promotions Limited Dispositif pour la réduction de nourriture d'un patient et l'utilisation dudit dispositif
EP0923356B1 (fr) * 1997-06-09 2002-09-04 Arnold Pier Sangle gastrique inserable par laparoscopie
US5910149A (en) * 1998-04-29 1999-06-08 Kuzmak; Lubomyr I. Non-slipping gastric band
US20060015151A1 (en) * 2003-03-14 2006-01-19 Aldrich William N Method of using endoscopic truncal vagoscopy with gastric bypass, gastric banding and other procedures
US20050119674A1 (en) * 2003-10-23 2005-06-02 Peter Gingras Gastric constriction device
US20090157107A1 (en) * 2006-08-21 2009-06-18 A.M.I. Agency For Medical Innovations Gmbh Device for the treatment of obesity

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2559410A1 (fr) * 2011-08-18 2013-02-20 A.M.I. Agency for Medical Innovations GmbH Dispositif de traitement de l'obésité

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