WO2016049481A1 - Procédé et dispositif pour la fermeture de perforations intra-cavitaires - Google Patents

Procédé et dispositif pour la fermeture de perforations intra-cavitaires Download PDF

Info

Publication number
WO2016049481A1
WO2016049481A1 PCT/US2015/052267 US2015052267W WO2016049481A1 WO 2016049481 A1 WO2016049481 A1 WO 2016049481A1 US 2015052267 W US2015052267 W US 2015052267W WO 2016049481 A1 WO2016049481 A1 WO 2016049481A1
Authority
WO
WIPO (PCT)
Prior art keywords
arms
tissue
perforation
closure
radiation
Prior art date
Application number
PCT/US2015/052267
Other languages
English (en)
Inventor
Anthony N. Kalloo
Mouen A. Khashab
Original Assignee
The Johns Hopkins University
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 The Johns Hopkins University filed Critical The Johns Hopkins University
Publication of WO2016049481A1 publication Critical patent/WO2016049481A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00349—Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system

Definitions

  • the invention relates to surgical devices and methods for closing leaks and perforations in and through the walls of bodily lumens.
  • Iatrogenic perforation is a major complication, which is difficult to endoscopically manage, and, if large, inevitably requires surgical repair. Perforations or leaks in the walls of internal organs and vessels may occur naturally (e.g., through rupture of herniated tissue) or formed unintentionally (e.g., as a result of a surgical procedure, such as tissue resection). In the latter respect, increasing practice of endoscopic therapies can increase the incidence of iatrogenic perforation in luminal tissues such as the gastrointestinal (GI) tract.
  • GI gastrointestinal
  • mucosal clips with single-layer tissue closure e.g., muscle layer to muscle layer
  • An omental patch is convenient for repair of lesions involving the anterior GI wall, but is difficult to apply to other GI organs and to more distal sites.
  • use of the omental patch has been limited to the stomach (see, e.g., Hashiba, A.M., et al, Gastrointest Endosc 54:500-504 (2001)).
  • the invention provides a device and method for its endoscopic use for full- thickness closure of leaks and perforations in the wall of an intraluminal bodily space, such as the gastrointestinal tract.
  • the device has a plurality of elongated arms defining a conical or umbrella-like shell, and an elongated central axis including a central apparatus attachable to a pusher or guidewire. At least two of the elongated arms terminate distally in a tissue-capturing structure, such as barbs or hooks.
  • the tissue-capturing structures are oriented such that the tips of the barbs or hooks radially extend outward from the elongated central axis of the device (as opposed to inward toward the central axis) when the device is in the undeployed and/or deployed configuration to facilitate capture of tissue.
  • the arms are formed of a biocompatible flexible resilient material, preferably a shape-memory material.
  • the material allows the shell to assume a compressed configuration with the arms folded down along the central axis and an expanded configuration with the arms extending away from the central axis with the tips of the tissue-capturing structures oriented away from the elongated central axis.
  • Placing the device into the first configuration allows the shell to be compressed into a through-the-scope tool; e.g., a delivery catheter. Delivery of the shell out of the proximal end of the tool allows the shell to resiliently assume an expanded configuration as the arms move outwardly.
  • a foldable biocompatible material e.g., a mesh
  • the tissue capture elements are treated to promote wound healing. It will be appreciated that the closure device is intended for surgical use only, and is neither intended nor adapted to be implantable. However, contact between the tissue capture elements and the tissues of the endoluminal space creates an environment where delivery or elution of wound healing promoting molecules could be useful.
  • the central axis of the device is releasably attachable to a pusher structure, such as a guidewire.
  • the device includes a system for its introduction into a luminal space to the site of a perforation or leak to be treated.
  • a system for its introduction into a luminal space to the site of a perforation or leak to be treated preferably includes an endoscope or comparable instrument for insertion into an intraluminal space (e.g., a laparoscope) and a loader catheter, into which the device may be provided pre-loaded.
  • the compressed shell of the device is inserted into a delivery tool, such as a loader catheter.
  • the loader catheter can be introduced through the accessory channel of a therapeutic endoscope and advanced through the perforation under endoscopic visualization.
  • the shell is advanced out of the loader catheter and through the perforation. Retraction of the shell causes the tissue-capturing structure to engage tissue surrounding the perforation or leak. As the shell is pulled back through the perforation, the shell is retracted with the tissue, pulling the full thickness of the latter back with it.
  • the fully retracted tissue is closed with a mechanical device, such as a clip, suture or band.
  • a mechanical device such as a clip, suture or band.
  • the tissue may be closed by sealing through application of energy or an adhesive thereto.
  • the retracted shell is withdrawn from the body following treatment.
  • the tissue capture elements are detached from the shell (e.g., by snipping them off the arms) and remain in the body.
  • a rubber band or suture may be deployed to close the perforation.
  • Figure 1A depicts a closure device of the invention in its compressed configuration.
  • Figure IB depicts a cross-sectional view of a closure device of the invention.
  • Figure 2 depicts a closure device of the invention being deployed from the proximal end of a loader catheter provided through an endoscope.
  • Figure 3 depicts a closure device of the invention in its expanded configuration, as engaged with the wall of a bodily lumen.
  • Figure 4 depicts a closure device of the invention engaged with the wall of a bodily lumen, the arms having been retracted and a sealing band having been deployed around the approximated perforation.
  • endoscope should be construed as including all types of invasive instruments, flexible or rigid, having scope features. These include, but are not limited to, colonoscopes, gastroscopes, laparoscopes, and rectoscopes. Similarly, the use of "endoscopic” is to be construed as referring to all types of invasive surgical scopes.
  • An endoscopic system, and a shell device according to this invention will be of particular use in full thickness closure of a perforation or leak, such as arising in for example, but without intending to be limiting, the bowel, rectum, appendix, gallbladder, uterus, stomach, esophagus, and other luminal cavities of the body.
  • An endoscope with accessory channels such as the CF2T-160L from Olympus, or DUETTE® from Cook Medical may be used to deliver a closure device of the invention.
  • Preferred materials for use in the supporting arms of the closure device of the invention are shape memory materials, such as NITINOL®, from Medtronic.
  • NITINOL® is a "shape memory alloy" based on nickel and titanium with moderate deformability.
  • Other shape memory materials having greater deformability may also be utilized, so long as (1) the arms of the closure device may be moved from a compressed configuration to an expanded configuration as described hereinbelow; and (2) the hooks or other capture elements on the proximal end of one or more of the supporting arms are sufficiently rigid to engage and remain secured in the serosa/adventitial wall of a luminal space when subjected to pulling force according to the invention.
  • the tissue capture elements may be detached from the shell and left behind in the intraluminal space.
  • the material used at least in the tissue capture elements may be a polymer with bioresorbable, thermoplastically deformable shape memory characteristics, such as those described in U.S. Patent Publication No. 2010/0262182, or a biological material, such as collagen.
  • the capture elements e.g., hooks
  • the proximal ends of the supporting arms may be formed of the same material as the supporting arms, or a different material. They may also be treated to with molecules known in the art to promote epithelialisation and wound healing (e.g., chitosan, steroids and the like).
  • the shell cover may be of any biocompatible material including, for leave behind applications, a bioabsorbable material (shape memory or not), such as polylactic acid (PLA), poly-glycolic acid (PGA), polylactide-co-glycolide, isomers and combinations thereof.
  • a bioabsorbable material shape memory or not
  • PLA polylactic acid
  • PGA poly-glycolic acid
  • the shell cover may also be formed of a biological material (e.g., collagen).
  • a closure device 1 of the invention is shown in its compressed configuration preloaded in loader catheter 11.
  • Arms 3 are attached at their proximal end to a central apparatus 5, which consists of a rod, and have hooks 2 at their distal ends. Hooks 2 are oriented such that they radially extend outward from the elongated central axis 15 of the device.
  • Arms 3 are moveable from a compressed configuration to an expanded, reverse umbrella shaped configuration (compare Figures 2 and 3); e.g., by bending near their attachment point to central apparatus 5 or along a mechanical pivot point.
  • central apparatus 5 is disposed through a loader catheter 11 and is attached at its proximal end (preferably releasably) or through a bore (not shown) disposed axially through central apparatus 5 to a pusher structure 9.
  • four arms are present; however, it will be apparent to those of ordinary skill in the art that a lesser or greater number of arms may be utilized; e.g., from at least 2 up to 20 arms, preferably 4-12 arms, most preferably 4-8 arms.
  • Figure IB also depicts the optional shell cover 8 disposed over arms 3.
  • Pusher structure 9 is shown in phantom in Figure 2 as a guidewire, but may be any equivalent structure, such as a rod or catheter. If a guidewire, pusher 9 may be a conventional wire or a self-centering guidewire, to facilitate insertion of the closure device through a perforation. Where a self-centering guidewire is utilized, the shell defined by arms 3 of closure device 1 need not be as large in diameter as compared to the diameter of the perforation being treated. In either embodiment, central apparatus 5 and pusher 9 are insertable through a loader catheter 11 for an endoscope 13.
  • the closure device is inserted into loader catheter 11 in its compressed configuration. Tension exerted by contact between the inner diameter of loader catheter 11 against arms 3 retains them in a downward attitude, compressed toward the elongated central axis 15 of device 1.
  • Endoscope 13 of is advanced to the site of the perforation to be treated in a body cavity and loader catheter 11 advanced through the perforation across line A- A', as shown in Figure 2.
  • the closure device is advanced distally out of loader catheter 1 1, by operation of pusher apparatus 9.
  • arms 3 resiliently deploy into the expanded configuration as the tension on arms 3 is released. As such, the arms 3 do not become fully deployed from the proximal end of the loader catheter until they have passed completely out of the loader catheter and through the perforation. Loader catheter 11 is then retracted.
  • arms 3 are fully deployed in an expanded configuration, device 1 is pulled back toward the perforation (in the direction indicated by the block arrow of Figure 3) until the hooks are captured into the serosal/adventitial surface 12 of the organ wall around the perforation site. Arms 3 then become expanded out into the intraluminal space 14 through the perforation along line A-A' by retraction of the central apparatus toward and back through the perforation. As device 1 is pulled backward, arms 3 and hooks 2 exert a pulling force on the serosal/adventitial surface 12, approximating the surrounding tissue of the perforation into the luminal space. The orientation of hooks 2 being extending substantially radially outward from the elongated central axis 15 of the device 1 facilitates perforation of the tissue by hooks 2 upon exertion of a pulling force.
  • Approximation of the tissue surrounding the perforation closes it and provides a treatment surface for sealing of the perforation.
  • Sealing can be accomplished by application of a clip, suture or staple to the everted tissue.
  • sealing may be accomplished for relatively small perforations or leak by application of energy to the everted tissue (causing tightening of tissue collagen; e.g., by operation of one or more radiofrequency, RF, electrodes disposed on arms 3 or introduced to the treatment site through endoscope 13) or by application of a biocompatible surgical adhesive.
  • Radiation applied to the tissue may include, by way of illustration, visible light, infrared radiation, microwave radiation, radio waves, very low frequency (VLF) radiation, extremely low frequency (ELF) radiation, and thermal radiation.
  • FIG. 4 Closure of the perforation after surrounding tissue of the perforation of the serosal/adventitial surface 12 is approximated into the luminal space is shown in Figure 4.
  • This embodiment illustrates deployment of a band 16 which is deployed around the approximated tissue to seal the perforation.
  • sealing may be accomplished by a number of other means.
  • the mucosa of the upper gastric body is lavaged with sterilized water and povidone-iodine via an accessory channel of the endoscope.
  • a pig with perforations or leaks created by incisions through the anterior wall of the GI tract is a suitable model for demonstration of the invention.
  • the endoscope is inserted into the peritoneal cavity to confirm a full-thickness incision of the gastric wall of at least 1 cm in diameter.
  • treatment is performed with a closure device of the invention having a 1.5 cm diameter shell according to the above- described method.
  • Oral intake is withheld during the immediate postanesthesia recovery period (about 6 hours).
  • the pigs may be fed a softened diet for several days and then a normal diet as tolerated.
  • the pigs are preferably also treated with antibiotics for 5 days.
  • follow-up endoscopy is performed, and the pig euthanized.
  • a necropsy may be performed to assess the perforation sites both intraluminally and intraperitoneally.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de fermeture, ayant des bras qui permettent de capturer et de rapprocher des tissus, et son procédé d'utilisation avec un dispositif de pénétration, tel qu'un endoscope, pour une fermeture complète de perforations et de fuites dans les parois d'un espace corporel intra-cavitaire. L'invention concerne un dispositif et son procédé d'utilisation endoscopique pour une fermeture complète de fuites et de perforations dans la paroi d'un espace corporel intra-cavitaire, tel que le tractus gastro-intestinal.
PCT/US2015/052267 2014-09-25 2015-09-25 Procédé et dispositif pour la fermeture de perforations intra-cavitaires WO2016049481A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462055444P 2014-09-25 2014-09-25
US62/055,444 2014-09-25

Publications (1)

Publication Number Publication Date
WO2016049481A1 true WO2016049481A1 (fr) 2016-03-31

Family

ID=55582068

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/052267 WO2016049481A1 (fr) 2014-09-25 2015-09-25 Procédé et dispositif pour la fermeture de perforations intra-cavitaires

Country Status (1)

Country Link
WO (1) WO2016049481A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070198057A1 (en) * 2006-02-21 2007-08-23 Daniel Gelbart Method and device for closing holes in tissue
US20100016885A1 (en) * 2008-07-21 2010-01-21 Eidenschink Tracee E J Device to close openings in body tissue
WO2012047815A2 (fr) * 2010-10-04 2012-04-12 The Johns Hopkins University Procédé et dispositif d'obturation de perforations intraluminales

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070198057A1 (en) * 2006-02-21 2007-08-23 Daniel Gelbart Method and device for closing holes in tissue
US20100016885A1 (en) * 2008-07-21 2010-01-21 Eidenschink Tracee E J Device to close openings in body tissue
WO2012047815A2 (fr) * 2010-10-04 2012-04-12 The Johns Hopkins University Procédé et dispositif d'obturation de perforations intraluminales

Similar Documents

Publication Publication Date Title
EP2846709B1 (fr) Dispositif d'inversion de diverticule
US8475476B2 (en) System and method for accessing a body cavity
US8460314B2 (en) Application of procedure through natural orifice
US8545525B2 (en) Planar clamps for anastomosis
US20180193050A1 (en) Diverticulum inverting device
US11317900B2 (en) Method and device for tissue acquisition or closure
US20100280313A1 (en) Systems and methods for endoscopic inversion and removal of diverticula
US11076856B2 (en) Anastomosis device
US20080125796A1 (en) Gastrotomy closure device
US20100191264A1 (en) Devices, systems and methods for diagnosing and delivering therapeutic interventions in the peritoneal cavity
US20130225900A1 (en) Method and Device for Closure of Intraluminal Perforations
EP3223717B1 (fr) Dispositif biomédical pour scellement étanche d'une ouverture
WO2013026474A1 (fr) Dispositifs et procédés d'ancrage d'un manchon endoluminal dans le tractus gastro-intestinal
CN208388669U (zh) 一种用于消化内镜手术带有缝合线的缝合针
EP3160362B1 (fr) Treillis expansible avec fonction de verrouillage
WO2016049481A1 (fr) Procédé et dispositif pour la fermeture de perforations intra-cavitaires
US10238392B2 (en) Methods for diagnosing and delivering therapeutic interventions in the peritoneal cavity
Bhurwal et al. Techniques for Fistula Repair in the GI Tract
WO2012150578A1 (fr) Dispositif et procédé de formation d'une anastomose

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: 15843905

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: 15843905

Country of ref document: EP

Kind code of ref document: A1