WO2016064385A1 - Dispositif de récupération à longue garniture frontale - Google Patents

Dispositif de récupération à longue garniture frontale Download PDF

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Publication number
WO2016064385A1
WO2016064385A1 PCT/US2014/061775 US2014061775W WO2016064385A1 WO 2016064385 A1 WO2016064385 A1 WO 2016064385A1 US 2014061775 W US2014061775 W US 2014061775W WO 2016064385 A1 WO2016064385 A1 WO 2016064385A1
Authority
WO
WIPO (PCT)
Prior art keywords
hood
retrieval
atraumatic
endoscope
flared
Prior art date
Application number
PCT/US2014/061775
Other languages
English (en)
Inventor
Andres Chamorro, Iii
David A. Melanson
Barry Maxwell
Original Assignee
Gi Dynamics, Inc.
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 Gi Dynamics, Inc. filed Critical Gi Dynamics, Inc.
Priority to EP14792973.1A priority Critical patent/EP3209188A1/fr
Priority to PCT/US2014/061775 priority patent/WO2016064385A1/fr
Priority to CN201480084257.8A priority patent/CN107105970A/zh
Publication of WO2016064385A1 publication Critical patent/WO2016064385A1/fr
Priority to IL251809A priority patent/IL251809A0/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00089—Hoods

Definitions

  • Endoscope retrieval and repositioning devices have been successfully used for removing and repositioning gastrointestinal implant devices within the gastrointestinal tract.
  • endoscope devices that increase safety and ease of use.
  • an endoscope hood device for moving a gastrointestinal implant device within a natural lumen of a gastrointestinal tract.
  • the endoscope hood device comprises an atraumatic flared retrieval hood that is configured to attach to and fit over a distal end of an endoscope, and that comprises a length configured to cover a plurality of protrusions on a surface of the gastrointestinal implant device, including both proximal facing protrusions and distal facing protrusions of the gastrointestinal implant device.
  • the atraumatic flared retrieval hood comprises a diameter configured to fit within a human esophagus without damage to the esophagus, and comprises a material of a bend radius configured to move slidably against the esophagus without damage to the esophagus.
  • an endoscope hood device for moving a gastrointestinal implant device within a natural lumen of a gastrointestinal tract, the device comprising a collapsible, atraumatic flared retrieval hood configured to attach to and fit over a distal end of an endoscope.
  • the hood comprises a length of between about 18 mm and about 36 mm from the distal end of the endoscope to a distal end of the atraumatic flared retrieval hood.
  • the atraumatic flared retrieval hood comprises a largest diameter of between about 10 mm and about 20 mm; a material of a durometer between about Shore 70A and about Shore 95 A; and a material of a bend radius of at least about 0.055 inches, the bend radius being measured at a bend of the atraumatic flared retrieval hood when the atraumatic flared retrieval hood is in a flattened configuration.
  • the bend radius of the atraumatic flared retrieval hood may be at least about 0.060 inches.
  • the bend radius may be measured at a distal tip of the atraumatic flared retrieval hood.
  • the atraumatic flared retrieval hood may comprise at least one of a urethane, an elastomer, and a silicone, such as a transparent urethane.
  • a retrieval device comprising any of the endoscope hood devices taught herein.
  • the retrieval device may further comprise the endoscope, the endoscope defining a lumen and providing an outer tube of the retrieval device.
  • the retrieval device may further comprise an inner tube defining a lumen and adapted for insertion into the endoscope; an elongated member having a proximal end and a distal end, the elongated member slidably disposed within the lumen of the inner tube; and a grasper disposed at the distal end of the elongated member, adapted to engage the gastrointestinal implant device to collapse at least a portion of the gastrointestinal implant device when operated.
  • the retrieval device may further comprise the gastrointestinal implant device, wherein the gastrointestinal implant device comprises: a flexible, floppy sleeve, open at both ends, to extend into the duodenum; a collapsible anchor coupled to a proximal portion of the sleeve; and a drawstring threaded through a proximal end of the anchor and drawn into the inner tube by the grasper. At least a proximal portion of the anchor may be captured within the retrieval hood such that the retrieval hood covers a plurality of protrusions on a surface of the gastrointestinal implant device, the plurality of protrusions comprising both proximal facing protrusions and distal facing protrusions of the gastrointestinal implant device.
  • the plurality of protrusions may comprise a plurality of muscle -penetrating barbs.
  • FIG. 1 A is a diagram of a retrieval device and gastrointestinal implant, in accordance with the prior art.
  • FIG. IB is a diagram of a retrieval device with a short endoscope hood, along with a collapsed anchor, in accordance with the prior art.
  • FIG. 2 is a diagram of a short endoscope hood retrieval device with a collapsed anchor, with the anchor retracted into the hood and with distal barbs exposed, in accordance with the prior art.
  • FIG. 3 is a diagram of a retrieval device with an extended endoscope hood, in accordance with an embodiment of the invention, with a collapsed anchor.
  • FIG. 4 is a diagram of a retrieval device in accordance with an embodiment of the invention, with a collapsed anchor retracted into the extended hood and with distal barbs fully covered.
  • FIGS. 5A-5C are schematic diagrams of an atraumatic flared retrieval hood, in accordance with an embodiment of the invention.
  • FIG. 6 is a diagram illustrating measurement of a bend radius of an atraumatic flared retrieval hood, in accordance with an embodiment of the invention.
  • FIG. 1 A is a diagram of such a retrieval device 100 that can be used to collapse and remove or reposition a gastrointestinal implant device 101 , in accordance with the prior art, as described in U.S. Patent No.
  • the retrieval device 100 may include a handle 1 14 supporting an actuator 120.
  • the retrieval device 100 further may include an elongated member 150, such as a wire.
  • the elongated member 150 is slidably disposed within the handle 1 14.
  • the actuator 120 is adapted to attach to a proximal end of the elongated member 150.
  • the retrieval device 100 further may include an inner tube 140.
  • the inner tube 140 defines a lumen within which the elongated member 150 is slidably disposed.
  • the inner tube 140 is adapted for insertion into a natural bodily lumen through an endoscope working channel or a catheter.
  • the inner tube 140 is fixed to a distal end of the handle 1 14.
  • a grasper 160 is coupled at a distal end of the elongated member 150 and is adapted to grasp a feature of an implantable device 101 , such as drawstring 280, such that manipulation of the drawstring 280 can reduce at least one dimension (e.g., the diameter) of the implantable device 101.
  • the grasper 160 may be any means of grasping a drawstring of an implantable device.
  • the grasper 160 attached to a distal portion of the elongated member 150, is disposed within a lumen of the inner tube 140.
  • the retrieval device 100 may further include an outer tube 130.
  • the outer tube 130 also defines a lumen within which the inner tube 140 may be slidably disposed.
  • the outer tube 130 is an insertion tube of an endoscope.
  • the endoscope may be a gastroscope, such as the Olympus GIF Q160, 9.8 mm OD, sold by Olympus Corporation of Tokyo, Japan.
  • the retrieval device 100 also includes a retrieval hood 103.
  • the retrieval hood 103 may be attached to a distal end of the outer tube 130.
  • the retrieval hood 103 is adapted to capture at least a proximal portion of the implantable device.
  • the retrieval hood 103 is coupled to the outer tube 130 using an interference fit, where the diameter of the proximal end of the retrieval hood 103 is slightly larger than the distal end of the outer tube 130.
  • the retrieval hood 103 may be coupled to the outer tube 130 using alternative mechanical, chemical, or bonding techniques.
  • the grasper 160 coupled to the distal end of the elongated member 150 is advanced towards a drawstring 280 positioned on the proximal end of the implantable device 101 by pushing on the actuator 120 (as indicated by arrow I.)
  • the distal end of the grasper 160 can extend distally beyond the outer tube 130, the retrieval hood 103, and the inner tube 140.
  • the gastrointestinal implant device 101 can comprise a flexible, floppy sleeve (see 113 in FIG. IB), open at both ends, to extend into the duodenum; a collapsible anchor 105 (see FIG.
  • any of the features of the retrieval device 100 of FIG. 1A may be used in combination with an extended endoscope hood, such as shown in the embodiments of FIG. 3 and following, in place of the short hood 103 of FIG. 1A.
  • FIG. IB is a further diagram of a retrieval device 100 with a short endoscope hood 103, collapsing a gastrointestinal implant device 101, in accordance with the prior art.
  • the grasper see 160 in FIG. 1A
  • retrieval hood 103 are used in conjunction with the endoscope 130.
  • the drawstring (see 280 in FIG. 1A) provided on the implant 101 is grasped with the grasper (see 160 in FIG. 1A) and pulled into the inner tube 140 (see FIG. 1A) to collapse the anchor 105.
  • the drawstrings 280 are located on the anchor 105 such that pulling on them collapses the anchor 105 radially.
  • the anchor protrusions such as muscle -penetrating barbs 106
  • the hood 103 on the endoscope 130 is advanced over the barbs 106 to cover them, as shown in FIG. 2, after which the implant 101 is safe to remove from the
  • the hood 203 has a comparatively short length, which is about 11mm as measured from the distal end of the endoscope to the distal end of the hood. Therefore, even with the anchor 205 retracted into the hood 203, the distal muscle-penetrating barbs 207 are exposed, which poses a potential danger to the patient as the implant is removed through the esophagus and mouth.
  • an embodiment according to the present invention provides an extended endoscope hood, which comprises several features, including a length configured to cover both proximal facing protrusions and distal facing protrusions on a surface of the
  • the atraumatic flared retrieval hood comprises a diameter configured to fit within a human esophagus without damage to the esophagus, and comprises a material of a bend radius configured to move slidably against the esophagus without damage to the esophagus.
  • FIG. 3 is a diagram of a retrieval device 300 in accordance with an embodiment of the invention, with a collapsed anchor 305. It can be seen that the hood 303 is of a longer length and shallower angle than the prior art hood 103 of FIG. IB. By comparison, the prior art hood of FIG. IB is short and only covers the proximal barbs 106 of the anchor 105, thereby limiting the implant to movement in a single direction during device retrieval. The prior art hood of FIG. IB was made comparatively short in order to provide a maximum field of view and maneuverability for the endoscope.
  • the hood 303 is designed to increase safety and ease of use.
  • the hood 303 covers both proximal and distal barbs, thereby preventing any scratching or tearing in the upper gastrointestinal tract during removal of the gastrointestinal implant device. It was previously thought that hood length would affect field of view and scope maneuverability negatively; however, it has been determined that the safety and ease of use of a hood in accordance with an embodiment of the invention are benefits that outweigh the slight differences in view and control.
  • FIG. 4 is a diagram of an extended endoscope hood device in accordance with an embodiment of the invention, with a collapsed anchor retracted into the hood. Both the proximal barbs 406 and distal barbs 407 are fully covered by the hood 403.
  • the grasper see 160 in FIG. 1A
  • the grasper is used to collapse the implant anchor 305 away from the duodenal wall. Once the anchor 305 is sufficiently collapsed and pulled away from the wall, it is retracted into the retrieval hood 303.
  • the geometry and material properties of the hood 303 allow for safe navigation down the upper gastrointestinal tract and into the pylorus and back.
  • the hood 403 fully covers both proximal barbs 406 and distal barbs 407. With all barbs covered, the user is able to move the endoscope in all directions without causing damage.
  • the wall geometry of the hood 403 allows the barbs 406, 407 to catch the distal edge 408 of the hood, so that the barbs 406,407 are folded over to be safely covered by the hood 403.
  • FIGS. 5A-5C are schematic diagrams of an atraumatic flared retrieval hood, in accordance with an embodiment of the invention.
  • FIG. 5A is a side view
  • FIG. 5B is a vertical section view
  • FIG. 5C is a sectional view through a base of the hood, in accordance with an embodiment of the invention.
  • the atraumatic flared retrieval hood 503 (see FIG. 5 A) is configured to attach to and fit over a distal end of the endoscope.
  • the length of the atraumatic flared retrieval hood 503 is between about 18 mm and about 36 mm from the distal end of the endoscope (positioned at approximately location 509) to the distal end 508 of the atraumatic flared retrieval hood 503.
  • the overall length of the hood is 1.39 inches (35.3 mm), such as between about 29.2 mm and about 47.2 mm, and its effective length (from the distal end of the endoscope to the distal end 508 of the atraumatic flared retrieval hood 503) is about .947 inches (24.1 mm), such as between about 18 mm and about 36 mm.
  • the largest diameter (for example at the distal end 508) of the atraumatic flared retrieval hood 503 may be between about 10 mm and about 20 mm, with the high end of the range being approximately the largest diameter that can fit through the human esophagus, and the low end of the range being determined by the diameter of the endoscope.
  • An angle 511 formed by the walls of the atraumatic flared retrieval hood 503 may be between about 20 degrees and 30 degrees, such as about 22 degrees.
  • the distal end 508 of the atraumatic flared retrieval hood 503 may include a bead feature around the diameter of the distal end 508.
  • the atraumatic flared retrieval hood 503 also may include retention features 510a/510b, shown in vertical sectional view in FIG. 5B.
  • the retention features 510a/510b may include openings between neighboring features around a circumference of the hood 503, between each set of features 510a and 510b, that assist in fitting the hood 503 onto the endoscope.
  • a bottom row of retention features 510a (see FIG. 5B) prevents motion of the retrieval hood 503 on the endoscope in a distal direction
  • a top row of retention features 510b prevents motion of the retrieval hood 503 on the endoscope in a proximal direction.
  • the features 510a and 510b may be offset from one another, so that openings between features 510a are offset from openings between features 510b. Such an offset improves moldability of the hood 503.
  • the endoscope may, for example, be a gastroscope, such as the Olympus GIF Q160, 9.8 mm OD, sold by Olympus Corporation of Tokyo, Japan; or another endoscope with a diameter from 8mm to 13.2mm.
  • the esophagus is not necessarily cylindrical in shape, and is actively moving, so that it can tend to flatten any retrieval hood as it is passed through the esophagus.
  • Applicants have realized that a retrieval hood that does not have a sufficiently large bend radius could potentially form a cutting edge when flattened, which can pinch or tear the tissue of the esophagus. Therefore, in accordance with an embodiment of the invention, the atraumatic flared retrieval hood 503 has a bend radius that is sufficiently large that the hood does not pinch or tear tissue when it is folded, which may be of particular concern for a patient's esophagus and/or epiglottis as a gastrointestinal implant device is removed.
  • the bend radius In order to prevent pinching or tearing, the bend radius must be larger than a minimum dimension, which may, for example, be at least about 0.055 inches (1.40 mm), or at least about 0.060 inches (1.52 mm). With such a minimum bend radius, the hood 503 can be almost fully collapsed at its distal diameter without creating sharp or traumatic edges.
  • the hood may, for example, have a thickness of about .072 inches (1.83 mm), although a thickness such as about 0.053 inches (1.35 mm) to about 0.078 inches (1.98 mm) may be used.
  • FIG. 6 is a diagram illustrating measurement of a bend radius of an atraumatic flared retrieval hood, in accordance with an embodiment of the invention.
  • the bend radius is measured at a bend 612 of the atraumatic flared retrieval hood when the atraumatic flared retrieval hood is in a flattened configuration.
  • the bend radius may be measured, for example, using a 1-inch clamp sold by Instron® of Norwood, MA, U.S.A., using a three-point diameter function that calculates a bend radius using an optical comparator.
  • the atraumatic flared retrieval hood 503 has a durometer that is sufficient to prevent the barbs from penetrating through the hood.
  • the durometer must also be high enough that the material does not stretch, causing a sharp edge, and soft enough that the hood can deform to fit through the esophagus.
  • the atraumatic flared retrieval hood may comprise a material of a durometer between about Shore 70 A and about Shore 95 A.
  • the atraumatic flared retrieval hood 503 may, for example, comprise at least one of a urethane, an elastomer, and a silicone; such as a transparent urethane.
  • the urethane TecoflexTM sold by The Lubrizol Corporation of
  • Wickliffe, OH, U.S.A. is an example of a material that may be used.
  • the material is a thermoplastic urethane with a durometer of Shore 85A.
  • the compressive force (flattening force) of the material may be around llbf +/- .251bf.
  • retrieval devices taught herein can be used to remove a gastrointestinal implant device from a gastrointestinal tract, and/or to reposition a
  • gastrointestinal implant device within a gastrointestinal tract.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un dispositif de garniture frontale pour un endoscope destiné à déplacer un implant gastro-intestinal à l'intérieur d'une lumière naturelle d'un tractus gastro-intestinal. Le dispositif de garniture frontale pour un endoscope comporte une garniture frontale de récupération évasée et a-traumatique conçue pour se fixer et s'ajuster sur une extrémité distale d'un endoscope. La garniture frontale de récupération évasée et a-traumatique présente une longueur conçue pour couvrir une pluralité de saillies sur une surface de l'implant gastro-intestinal, la pluralité de saillies comportant à la fois des saillies faisant face à l'extrémité proximale et des saillies faisant face à l'extrémité distale de l'implant gastro-intestinal. La garniture frontale de récupération évasée et a-traumatique possède un diamètre conçu pour s'ajuster à l'intérieur d'un œsophage humain sans l'endommager et comporte un matériau dont un rayon de courbure est conçu pour se déplacer de manière coulissante contre l'œsophage sans l'endommager.
PCT/US2014/061775 2014-10-22 2014-10-22 Dispositif de récupération à longue garniture frontale WO2016064385A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP14792973.1A EP3209188A1 (fr) 2014-10-22 2014-10-22 Dispositif de récupération à longue garniture frontale
PCT/US2014/061775 WO2016064385A1 (fr) 2014-10-22 2014-10-22 Dispositif de récupération à longue garniture frontale
CN201480084257.8A CN107105970A (zh) 2014-10-22 2014-10-22 长罩式取出装置
IL251809A IL251809A0 (en) 2014-10-22 2017-04-19 Long hooded retriever

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2014/061775 WO2016064385A1 (fr) 2014-10-22 2014-10-22 Dispositif de récupération à longue garniture frontale

Publications (1)

Publication Number Publication Date
WO2016064385A1 true WO2016064385A1 (fr) 2016-04-28

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PCT/US2014/061775 WO2016064385A1 (fr) 2014-10-22 2014-10-22 Dispositif de récupération à longue garniture frontale

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Country Link
EP (1) EP3209188A1 (fr)
CN (1) CN107105970A (fr)
IL (1) IL251809A0 (fr)
WO (1) WO2016064385A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3052048A1 (fr) * 2016-06-06 2017-12-08 Assist Publique - Hopitaux De Paris (Ap-Hp) Capuchon endoscopique a paroi renforcee

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08228997A (ja) * 1995-02-24 1996-09-10 Sekisui Chem Co Ltd 透明フード
JP2001275933A (ja) * 2000-03-31 2001-10-09 Olympus Optical Co Ltd 内視鏡用フード
US20010053909A1 (en) * 2000-05-26 2001-12-20 Olympus Optical Co., Ltd. Endoscope hood for mucous membrane resection
US20060212042A1 (en) * 2005-03-17 2006-09-21 Lamport Ronald B Removal and repositioning device
US8771219B2 (en) 2003-12-09 2014-07-08 Gi Dynamics, Inc. Gastrointestinal implant with drawstring

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005095582A (ja) * 2003-08-21 2005-04-14 Olympus Corp 内視鏡用フード

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08228997A (ja) * 1995-02-24 1996-09-10 Sekisui Chem Co Ltd 透明フード
JP2001275933A (ja) * 2000-03-31 2001-10-09 Olympus Optical Co Ltd 内視鏡用フード
US20010053909A1 (en) * 2000-05-26 2001-12-20 Olympus Optical Co., Ltd. Endoscope hood for mucous membrane resection
US8771219B2 (en) 2003-12-09 2014-07-08 Gi Dynamics, Inc. Gastrointestinal implant with drawstring
US20060212042A1 (en) * 2005-03-17 2006-09-21 Lamport Ronald B Removal and repositioning device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3052048A1 (fr) * 2016-06-06 2017-12-08 Assist Publique - Hopitaux De Paris (Ap-Hp) Capuchon endoscopique a paroi renforcee
WO2017212163A1 (fr) * 2016-06-06 2017-12-14 Assistance Publique - Hopitaux De Paris (Ap-Hp) Capuchon endoscopique a paroi renforcée

Also Published As

Publication number Publication date
CN107105970A (zh) 2017-08-29
IL251809A0 (en) 2017-06-29
EP3209188A1 (fr) 2017-08-30

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