WO2011092707A1 - Dispositif de déploiement d'un fil guide en bobine, procédé de guidage de celui-ci à travers le tractus gastro-intestinal et procédé de fabrication associé - Google Patents

Dispositif de déploiement d'un fil guide en bobine, procédé de guidage de celui-ci à travers le tractus gastro-intestinal et procédé de fabrication associé Download PDF

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Publication number
WO2011092707A1
WO2011092707A1 PCT/IL2011/000111 IL2011000111W WO2011092707A1 WO 2011092707 A1 WO2011092707 A1 WO 2011092707A1 IL 2011000111 W IL2011000111 W IL 2011000111W WO 2011092707 A1 WO2011092707 A1 WO 2011092707A1
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WO
WIPO (PCT)
Prior art keywords
guidewire
filament
proximal
housing
distal
Prior art date
Application number
PCT/IL2011/000111
Other languages
English (en)
Inventor
Shomron Silan Ben-Horin
Aaron Marelly
Eyal David Ben-Ami
Moshe Goldstien
Original Assignee
Ipu Industries Ltd.
Tel Hashomer Medical Research Infrastructure And Services Ltd.
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 Ipu Industries Ltd., Tel Hashomer Medical Research Infrastructure And Services Ltd. filed Critical Ipu Industries Ltd.
Publication of WO2011092707A1 publication Critical patent/WO2011092707A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • 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
    • A61B1/00147—Holding or positioning arrangements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21C—MANUFACTURE OF METAL SHEETS, WIRE, RODS, TUBES OR PROFILES, OTHERWISE THAN BY ROLLING; AUXILIARY OPERATIONS USED IN CONNECTION WITH METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL
    • B21C47/00—Winding-up, coiling or winding-off metal wire, metal band or other flexible metal material characterised by features relevant to metal processing only
    • B21C47/02—Winding-up or coiling
    • B21C47/04—Winding-up or coiling on or in reels or drums, without using a moving guide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21C—MANUFACTURE OF METAL SHEETS, WIRE, RODS, TUBES OR PROFILES, OTHERWISE THAN BY ROLLING; AUXILIARY OPERATIONS USED IN CONNECTION WITH METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL
    • B21C47/00—Winding-up, coiling or winding-off metal wire, metal band or other flexible metal material characterised by features relevant to metal processing only
    • B21C47/16—Unwinding or uncoiling
    • B21C47/18—Unwinding or uncoiling from reels or drums
    • B21C47/20—Unwinding or uncoiling from reels or drums the unreeled material moving transversely to the tangent line of the drum, e.g. axially, radially
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21C—MANUFACTURE OF METAL SHEETS, WIRE, RODS, TUBES OR PROFILES, OTHERWISE THAN BY ROLLING; AUXILIARY OPERATIONS USED IN CONNECTION WITH METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL
    • B21C47/00—Winding-up, coiling or winding-off metal wire, metal band or other flexible metal material characterised by features relevant to metal processing only
    • B21C47/28—Drums or other coil-holders
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65H—HANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
    • B65H54/00—Winding, coiling, or depositing filamentary material
    • B65H54/02—Winding and traversing material on to reels, bobbins, tubes, or like package cores or formers
    • B65H54/04—Winding and traversing material on to reels, bobbins, tubes, or like package cores or formers for making packages with closely-wound convolutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65H—HANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
    • B65H55/00—Wound packages of filamentary material
    • B65H55/04—Wound packages of filamentary material characterised by method of winding
    • B65H55/043—Wound packages of filamentary material characterised by method of winding the yarn paying off through the centre of the package
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65H—HANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
    • B65H57/00—Guides for filamentary materials; Supports therefor
    • B65H57/18—Guides for filamentary materials; Supports therefor mounted to facilitate unwinding of material from packages
    • 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
    • A61B1/04—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 combined with photographic or television appliances
    • A61B1/041—Capsule endoscopes for imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09108—Methods for making a guide wire

Definitions

  • the present invention relates to a device and methods for deploying a spooled gastrointestinal guidewire through the gastrointestinal tract and a method of manufacturing the device.
  • a gastrointestinal guidewire is positioned through the gastrointestinal tract and is configured to act as a scaffold through the length of the gastrointestinal tract.
  • Imaging of the lumen can be accomplished by various flexible fiber optic endoscopes, introduced through the mouth (gastroscopes or enteroscopes) or the anus (colonoscopes). These procedures, especially colonoscopy and enteroscopy, require various manual maneuvers by the operator, usually a physician, in order to advance the endoscope while avoiding its looping, thereby making insertion of the endoscope technically demanding.
  • the DBE consists of two balloons which are inflated and deflated sequentially by the operator, in order to alternately fix and advance an overtube and an internal enteroscope through the intestine.
  • This is a technically demanding and lengthy procedure, necessitating heavy sedation of the patient, and is also seldom successful in traversing the entire small intestine in a single procedure from a single orifice (i.e. mouth or anus).
  • capsule endoscopy is currently the mainstay method for diagnosis of disorders of the small intestine, and is also gaining acceptance for visualizing the upper and lower gastrointestinal tract.
  • This method comprises oral administration to a subject of a capsule equipped with a camera that transmits the images obtained to an external recorder. The images are viewed on a screen by an operator at a later time.
  • One such capsule is disclosed in US Patent No. 5,604,531.
  • a major limitation of capsule endoscopy is that operator-controlled movement is unavailable at present, and images are obtained while the capsule advances passively along the gastrointestinal tract solely by the force of intestinal motility. This, in turn, hampers visualization of particular segments of interest, or of the complete length of the tract, as movement of the capsule is random.
  • capsules do not traverse the entire small intestine before their battery runs out, and similarly, sections of interest may be overlooked or missed because of rapid peristalsis carrying the capsule briskly forward across a lesion.
  • the random and uncontrollable capsule movement also precludes operator-guided lesion-specific intervention, such as the procurement of tissue for biopsy, manipulations to control bleeding or targeted drug delivery.
  • the period during which the capsule traverses the gastrointestinal tract generally takes place outside of the clinic (at home, for example), during which time a film of the gastrointestinal tract is produced. Because the patient is outside of the clinic, the possibility of biopsy is eliminated.
  • the produced film is generally lengthy (approximately 7 hours), necessitating long hours of review on the part of the doctor.
  • the passive peristalsis-dependent movement of capsules is also a major obstacle in the use of capsule endoscopy for colon visualization, as physiologic colonic transit time is in the order of 48 hours i.e. much longer than small intestine transit time. While the colon transit time can be shortened by vigorous purgative and pro-kinetic regimens, such procedures are disagreeable for patients and can entail a lack of patient compliance. Moreover, even then a significant fraction of capsules still do not traverse the entire colon and are not expelled from the anus before their battery runs out at the end of study, thereby compromising and adversely affecting the diagnostic utility of capsules for studies of the human colon.
  • US Patent No. 7,226,410 discloses a device for performing medical procedures inside a body lumen such as the gastrointestinal tract, wherein the device comprises a capsule attached to a cable, wherein the distal end of the cable is arranged in a loop which unfurls within the gastrointestinal lumen and lays down a track upon which the capsule is manipulated forward or backward by a propulsion mechanism.
  • both the laying down of the cable and the movement of the capsule require manipulations by an operator i.e. the cable is laid out as the operator slides it through the device, and the capsule is propelled along the cable as the operator activates a motion control unit.
  • US Patent No. 6,632,171 discloses a clamp device for manually positioning an endoscopic capsule within the gastrointestinal tract.
  • US Patent No. 6,884,213 discloses a hydraulically operated injecting device for positioning an endoscopic capsule within the gastrointestinal tract.
  • US Patent No. 6,936,003 discloses a device which includes one or more extendible arms, termed proboscises, and an in vivo medical instrument, such as an endoscopic capsule, wherein the proboscises can perform different functions, including moving and propelling the device.
  • 6,986,738 discloses a system comprising a tube and an in vivo sensing device that is changeably connected to the tube, for example, through an elastic cord or wire, and wherein the position of the sensing device with respect to the tube can be changed.
  • US Patent No. 6,939,290 discloses an in vivo sensing device comprising a sensor, such as an endoscopic capsule, and a non-protruding magnetohydrodynamic propulsion system. All of the aforementioned positioning systems are considerably dependent on a high level of technical skill of the operator.
  • Digestible diagnostic capsules with extractable strings are used in the stomach for measurement or diagnosis.
  • a patient holds the free end of the gastric string, and then swallows the capsule, during which time the string exits the capsule as it travels through the esophagus and enters the stomach.
  • the capsule then either dissolves or passes through the patient's digestive system, leaving the string within the stomach.
  • the string is withdrawn, and the end of the string that was in the stomach is subsequently tested for various indicators, such as the presence of certain microorganisms or to measure the pH of the stomach content.
  • Such devices are disclosed, for example, in U.S. Patent Nos. 3,528,429; 3,683,890, and 5,738,110. These devices, however, are not designed to traverse the lower gastrointestinal tract such as the small and large intestines.
  • Ramirez et al. disclose a wireless capsule endoscopy device attached to a string to allow its controlled movement up and down the esophagus. After ingestion, the capsule obtains images of the esophagus and stomach, and is then withdrawn through the mouth by the operator for repeated future use (Ramirez FC et al, Gastrointestinal Endoscopy 2005; 61(6) 741-6).
  • US Patent No. 7,037,275 discloses a gastrointestinal sampling device which is a capsule comprising a malleable drag material, inter alia absorbent string, cotton, sampling cloth, wool, acrylic, nylon, plastic, chain links or finely woven metal, and a protective sheath which is deployed around the drag material upon withdrawal of the device.
  • a weight is attached to one end of the drag material in order to manipulate its position by application of an external magnetic force.
  • endoscopes e.g. endoscopic capsules, as well as other diagnostic capsules (e.g. pH recording capsules, chemical sampling capsules, etc) or gastrointestinal devices significantly diminishes their diagnostic and therapeutic utility. Additionally, the tortuous and redundant nature of the small intestine poses a significant obstacle for manual advancement of endoscopes through the small intestine. Accordingly, there is a great need in the art for a means of controlling the movement of diagnostic and therapeutic gastrointestinal devices.
  • US Patent Number 5,879,325 discloses introduction of a tube through a gastrointestinal tract for the purpose of introducing substances at locations along the gastrointestinal tract.
  • the tube is pulled through the gastrointestinal system from a location external to the gastrointestinal system, which may cause discomfort and limits the options for introduction of the tube.
  • US Publication No. 20050228363 to Leiboff discloses a method for draining the colon by inserting a drainage tube into a colon, by inserting a guidewire into the colon through the anus and rectum; pushing and manipulating the guidewire forward through the colon to the cecum; to draw a filament through which a drainage tube is extended.
  • the present invention overcomes these deficiencies of the background art by providing a device for deploying a GI biocompatible guidewire through the length of the GI system providing for observing the different sections of the GI in a controllable manner and time independent manner along the length of the GI tract.
  • At least a portion of the guidewire body is configured to be released from the interior portion through the guidewire outlet into the gastrointestinal tract as the introducing element moves through the gastrointestinal tract.
  • the gastrointestinal guidewire is then configured to be used as a scaffold for guiding a gastrointestinal device through the gastrointestinal tract.
  • a preferred embodiment of the present invention provides for a device for scaffolding the GI tract, configured to overcome the resistive, negative and/or backward moving forces, of the GI tract, for example drag, friction, while utilizing the natural, positive and/or forward moving forces, provided by the natural involuntary muscular movements within the GI, for example provided by smooth muscle peristalsis, to deploy and/or release a guidewire filament within the GI tract acting as a scaffold therein.
  • guidewire guidewire filament, filament, strand, string may be used interchangeably throughout this text to refer to the guidewire deployed within the GI tract and optionally used as a scaffold for introducing other devices.
  • the guidewire is composed of biocompatible materials as is known and accepted in the art.
  • the guidewire according to the present invention provides for a continuous guidewire filament comprising at least two filaments that are preferably associated with one another in a form for example including but not limited to braided, entwined, woven, twisted, intertwined, interweaved, interlaced, interlinked, interleaved, entangled, laced or the like in any combination thereof.
  • the guidewire filament may be provided wherein each of the at least two filaments are provided as filaments comprising the same properties.
  • the guidewire filament may be provided wherein each of the at least two filaments are provided as filaments comprising different properties.
  • the guidewire filament may be provided wherein each of said at least two filaments are provided as filaments comprising a combination of different and/or the same properties.
  • coreless bobbin referrers a bobbin that is loaded with guidewire filament that does not have a core to hold, shape and/or maintain the guidewire on the bobbin or the shape of the bobbin once it is spun.
  • the coreless bobbin is a self containing bobbin made of spun guidewire.
  • units for force may be interchangeably referred to and provided using units of grams, gram-force, 'gf and/or 'g' to refer to the SI unit of force, Newton and/or referenced shorthand 'N', such that 1 N of force is equivalent to 101.971621298 g or 1 g of force is equivalent to 0.00980665N, or multiples thereof. 2g - 10 g being equivalent to 0.0196133N - 0.0980665N.
  • An optional embodiment of the present invention provides for a gastrointestinal device that may be customized according to at least one or more device parameters, for example including but not limited to guidewire filament parameters, housing parameters, attachment points and configuration, sealing parameters, weigh control parameter or the like.
  • device parameters for example including but not limited to guidewire filament parameters, housing parameters, attachment points and configuration, sealing parameters, weigh control parameter or the like.
  • control of such parameters provides for control and customization of the device deployments through the GI tract.
  • guidewire parameters for example may include but are not limited to wire tension, material, composition, segmentation, coating, medicaments, total length, segmentation length, force, weight, threading types and size or the like parameters.
  • guidewire parameters for example force, provides for controlling the time spent in each location within the GI tract. For example, the length of time spent in different portions of the GI tract (stomach, small intestine, and large intestine), time spent within different segments or portions of the GI tract (ileum, jejunum etc.), location and time specific within GI tract.
  • the guidewire according to the present invention may be provided in a plurality of optional guidewire tensile force that may optionally be provided from about 1 g up to about 15g (equivalent to 0.00980665N - 0. 0.14709975N).
  • about 1 g up to about 15g equivalent to 0.00980665N - 0. 0.14709975N.
  • between 2g - 10 g (equivalent to 0.0196133N - 0.0980665N) optionally and preferably between 2.5-8g (equivalent to 0.024516625N - 0.0784532N), more preferably from about 4-7 g (equivalent to 0.0392266N - 0.06864655N) and most preferably about 6g (equivalent to 0.0588399N).
  • the device, guidewire filament and spooling apparatus may provide the device and/or guidewire with a resistance force within a desired range that is lower than the propulsive peristaltic force of the GI tract yet higher than an exiting force threshold.
  • the exiting force threshold may be determined as a function of the GI tract's propulsive peristaltic force.
  • the exiting force threshold may be from about 85% and up to about 100% of the propulsive peristaltic force.
  • the exiting force threshold may for example be 85%, 88%, 90%, 92%, 94%, 95%, 96%, 97%, 98%, 99% of the propulsive peristaltic force.
  • the exiting force threshold may be 85% of the propulsive peristaltic force.
  • the device of the present invention may be configured such that the guidewire filament is released and/or unspooled from the device housing into the subject's GI with an exiting force that is substantially equivalent to the propulsive peristaltic forces of the GI tract and preferably within a force range of 2- 1 Ogr.
  • the device, guidewire filament, spooling apparatus and spooling method may provide the device and guidewire with sufficient resistive force to nearly match the propulsive forces of the GI tract, for example equivalent to about 2g - 10 g (equivalent to 0.0196133N - 0.0980665N), such that the guidewire filament is released and/or unspooled from the device housing of the present invention with an exiting force equivalent to about 2g - 10 g (equivalent to 0.0196133N - 0.0980665N),
  • the device's spooling apparatus and/or guidewire filament may be adjusted to match different forces exerted within the GI tract of a subject.
  • the device's spooling apparatus and/or guidewire filament may be adjusted to allow for guidewire release and extension within a GI exhibiting a propulsive force of about 25g (equivalent to 0.24516625N).
  • the device according to the present invention may be configured such that the guidewire exiting force is configured to be relative to the GI tract's propulsive peristaltic force.
  • the guidewire exiting force may be configured to be from about 85% to about 100% of the GI tract's propulsive peristaltic force.
  • the guidewire exiting force may be configured to be about 85% or about 90% or about 92% or about 95% or about 96% or about 97% or about 98% or about 99% or about 100%, relative to the GI tract's propulsive peristaltic force.
  • the guidewire is provided in a single continuous filament.
  • the guidewire may be provided as a continuous filament with a plurality of segments each having variable and/or independent guidewire properties.
  • the polymer composing the guidewire may be chosen from the group consisting of nitinol, intestine, collagen, polyethylene, poly glycolic acid, poly lactic acid, polyurethane, PTFE, polystyrene polysterene, polyvinyl chloride, polypropylene, silicon, polycarbonate, polysopeme, surgical suture or the like materials as is known in the art.
  • the guidewire may comprise at least two or more threads and/or strands that may for example be braided, entwined, woven, twisted, intertwined, interweaved, interlaced, interlinked, interleaved, laced provided to form a continuous guidewire filament according to the present invention.
  • each thread and/or strand may be provided of different materials.
  • each thread and/or strand may be provided of the same materials.
  • the guidewire may comprise a plurality of threads and/or strands that may for example be braided, entwined, woven, twisted, intertwined, interweaved, interlaced, interlinked, interleaved, laced provided to form a continuous guidewire filament according to the present invention.
  • each thread and/or strand may be provided of different materials.
  • each thread and/or strand may be provided of the same materials.
  • the guidewire may be coated with a plurality of materials for example including medicaments, drugs, radio-opaque materials, radioactive materials, or the like.
  • the guidewire may be composed of at least one or more varying materials.
  • guidewire may be differentially coated along its length providing segmentation, optionally and preferably according to GI anatomy and relative properties.
  • the guidewire portion spanning the stomach may be acid resistant while the remaining guidewire portions spanning the GI tract may be acid labile.
  • the guidewire may form a continuous filament that is able traverse at least a portion of the GI tract, more preferably the guidewire may form a continuous filament spanning most of the GI tract, optionally and preferably the guidewire may form a continuous filament spanning the length of the GI tract from the mouth to the anus.
  • housing parameters may for example include but are not limited to housing weight, individual component weights, housing materials, weight distribution, outlet size and shape or the like.
  • the device according to the present invention may be provided in a plurality of shapes for example including but not limited to a capsule, pill, tablet, ellipsoid, discoid, or the like shape.
  • the shape of the device is controllable and provided based on the controllable parameters described above.
  • the device shape is determined based on optimal travel through the GI tract.
  • the device according to the present invention in any of its parameters may be customized for individual and/or subject using the device, particularly based on the GI anatomy within which the device is being deployed and/or for what purpose.
  • the device shaped, weight distribution, length of guidewire, tensile strength of guidewire, guidewire composition or the like parameters may be customized for use based on the subject.
  • a device would be of specific parameters when used for a horse based on equine GI anatomy and device parameters as opposed a device adapted for use within a pig or human GI tract.
  • the overall weight of the device according to the present invention is controllable.
  • the overall weight of the device may be at least about 2grams optionally up to about 6grams and most preferably about 4grams.
  • the device according to the present invention comprises a weight providing for control of the overall device weight.
  • the weight of the device may be provided to control the overall weight distribution of the device according to the present invention, wherein optionally some portion of the device may be heavier than others.
  • the weight distribution may be balanced, skewed to one side of the device, or changing shifting.
  • the guidewire outlet portion may be heavier than the opposite portion
  • An optional embodiment of the present invention for a method for deploying the GI guidewire device of the present invention through at least a portion of the GI tract, and most preferably spanning the length of the GI tract comprising: anchoring the proximal end of the guidewire filament, optionally to a portion of the GI tract and/or oral cavity; and
  • the GI device may be anchored in a non invasive manner for example by anchoring to a portion of the oral cavity such as the teeth, cheek, neck, nose or the like.
  • the GI device may be anchored in a minimally invasive manner for example including but not limited to a laryngoscope, endoscope of the like.
  • the GI device may be anchored in an invasive manner for example an internal portion of the GI tract such as the stomach.
  • An optional embodiment of the present invention is for a method and apparatus for the manufacture of the GI guidewire deployment device according to the present invention, comprising a spooling device having an angled spooling axis.
  • the guidewire filament is spooled onto an angled spooling axis, for example a conical axis having a wide base diameter and a narrower tip diameter.
  • the spooling axis angle is controllable and correlates to the properties guidewire utilized, for example including but not limited to guidewire length, guidewire tension.
  • a guidewire of about 30 meters is spooled on a conic spooling axis having an angle from about 0.5 to 1.5 degrees.
  • the guidewire bobbin is oriented wherein the wide base is provided at the guidewire deployment end.
  • the guidewire bobbin is oriented wherein the narrow base is provided at the guidewire deployment end.
  • the guidewire material is spooled into a coreless bobbin wherein the guidewire is deployed form the inside out.
  • the second housing comprises a seal for sealing the coreless guidewire bobbin from gastric juices from within the GI tract and weight.
  • the method, apparatus and/or device according to the present invention may be altered to provide for a capsule that may further comprise devices for example including but not limited to active sensors, passive sensors, camera or the like optionally and preferably within the capsule body.
  • a camera may be inserted into a portion of the capsule body to provide images while deploying the guidewire according to the present invention.
  • the device, apparatus may be provided in a plurality of optional forms for example including but not limited to an off the shelf product, a customized product, a single use disposable product, OEM product or the like.
  • the device and/or apparatus may be provided as an OEM product that may optionally be integrated into a final product during the manufacturing process of a GI tract device.
  • a medical device steered and/or maneuvered and/or navigated over the previously laid guidewire filament within the GI tract may comprise radioactive material in whole or in part, for example for delivering irradiation brachytherapy to malignant or pre-malignant lesions in the digestive tract or in body organs adjacent to it.
  • the guidewire filament may comprise and or otherwise associate with radioactive materials, radio-opaque markers, and/or the like.
  • the length and/or portions of the guidewire filament may comprise and/or otherwise provided with radio-opaque markers, radioactive materials or the like.
  • radioactive materials disposed along the guidewire filament may be provided for delivering irradiation to a tissue, for example a therapeutic radioactive dose.
  • irradiation may be provided in the form of brachytherapy to malignant and/or pre-malignant lesions in the digestive tract, and/or adjacent organs and/or organs.
  • FIG. lA-C are schematic illustrations of a spooling apparatus for assembling a gastrointestinal device according to the present invention.
  • FIG. 3A-D are schematic illustrations for assembling the gastrointestinal device according to an optional embodiment of the present invention.
  • FIG. 3A-D are schematic illustrations for assembling the gastrointestinal device according to an optional embodiment of the present invention.
  • FIG. 5A depict an optional method for deploying the GI device according to optional embodiments of the present invention through the GI tract;
  • FIG. 5B depicts an optional method for assembling the GI device according to optional embodiment of the present invention.
  • the present invention is of a device and method of use of a GI device and a method for assembling a gastrointestinal (GI) device for the deployment of a GI guidewire through the length of a gastrointestinal tract.
  • GI gastrointestinal
  • Figures 1A-C collectively provide schematic diagrams of an exemplary apparatus for spooling and/or winding a coreless bobbin GI guidewire filament not shown in these views (see Figure 2A-C) according to an optional embodiment of the present invention.
  • Figure 1A shows a proximal spooling spinning wheel 10, of a standard state of the art spooling machine tat may be adapted for use in accordance with the optional embodiments of the present invention.
  • Spinning wheel 10 is preferably securely coupled with spooling axis 12.
  • Optionally and preferably spooling axis 12 comprises a gentle slope along its length wherein its distal tip 12d is most preferably smaller than and therefore angled relative to its proximal base 12p.
  • Optionally and preferably spooling axis is provided with an angle optionally of up to about 5 degrees, optionally up to about 3 degrees, more preferably up to about 2 degrees, most preferably from about 0.5 degrees to about 1.5 degrees, or the like angle.
  • Most preferably axis 12 provides for an axis about which guidewire filament 110 (not shown) is wound to produce a coreless guidewire bobbin 100 according to the present invention.
  • Figure IB depicts a proximal stopper 102 and a distal stopper 104 forming the proximal and distal edges of the coreless bobbin according to the present invention. Most preferably distal stopper 102 is disposed over distal tip 12d and proximal stopper 104 is disposed along proximal base 12p.
  • Figure 1C depicts the apparatus of Figure IB wherein spindle axis 12 is associated with axis adaptor 20 that is associated with distal spinning wheel 30.
  • spindle axis 12 is associated with axis adaptor 20 that is associated with distal spinning wheel 30.
  • axis adaptor 20 that is associated with distal spinning wheel 30.
  • proximal spinning wheel 10 cause axis 12 to spin therein winding filament 110 (not shown) along axis 12 forming a coreless guidewire bobbin 100 most preferably between proximal stopper 102 and distal stopper 104.
  • Figure 2 A shows guidewire filament 1 10 having a proximal end 1 lOp that is optionally and preferably threaded through the central opening of proximal stopper 102 prior to coupling along spooling axis 12.
  • guidewire filament 110 is drawn from a filament source (not shown) and spun along axis 12 between proximal stopper 102 and distal stopper 104.
  • Figure 2B depicts guidewire filament 1 10 following spooling the along axis 12 where filament 1 10 is cut from its source (not shown) leaving both a proximal end 1 lOp and a distal end 1 lOd.
  • both ends of guidewire filament 110 are loose ends as schematically depicted in Figure 2B.
  • Figure 2C shows a similar view to Figure 2B wherein the distal spinning wheel 30 and adaptor 20 have been removed leaving the coreless guidewire bobbin 100 disposed over axis 12.
  • coreless guidewire bobbin 100 according to an optional embodiment of the present invention is provided once spooling axis 12 is disassociated from wound filament 1 10, proximal stopper 102 and distal, stopper 104.
  • Figure 3A depicts the next stage in assembling the GI device according to the present invention wherein a distal housing 122 is placed over coreless guidewire bobbin 100, as depicted in Figure 2C, optionally and preferably such that the diameter of distal stopper 104 and the diameter of the coreless bobbin fit within the cavity of housing 122.
  • distal stopper 104 is associated with or otherwise coupled with housing 122, for example by fitting into the cavity of housing 122 or by coupling means for example including but not limited to threading, pressure, suction, clamp, claps, hook and loop, corresponding cog and recess or the like provided for securely associating housing 122 with distal stopper 104.
  • distal tip 12d is not coupled or otherwise associate with housing 122.
  • distal tip 12d provides for determining spacing between distal stopper 104 and the inner surface f housing 122.
  • Figures 3B-C provide a schematic illustrative view of coreless guidewire bobbin 100 associated with spindle axis 12 but disassociated from proximal spindle device spinning wheel 10 forming an intermediate distal assembly 200 comprising spindle 12 loaded with GI device distal assembly 120.
  • distal assembly 120 comprises, distal housing 122, associated with guidewire 1 10 loaded onto coreless spool 100 showing free proximal end 1 lOp.
  • Figure 3C provides a cross-section of Figure 3B revealing coreless spool 100 defined by a proximal base 102 and distal base 104 between which guidewire filament 110 is spun about spindle axis 12. Most preferably spindle axis is removed as shown in Figure 3D leaving an axis free coreless bobbin 100 within housing 122 therein forming distal assembly 120.
  • Figure 3D provides a schematic perspective view of distal assembly 120 preferably in its finalized form where spooling spindle axis 12 has been removed from intermediate distal assembly 200, described in Figures 3B-C. Most preferably distal assembly 120 forms the distal portion of GI device 150 ( Figures 4A-C).
  • Figure 4 A provides an exploded view of a preassembled GI device 150 according to the present invention where most preferably distal assembly 120 is coupled with proximal assembly 130.
  • proximal assembly 130 comprises proximal housing 132, seal 134 and 136 weight.
  • guidewire proximal free end 11 Op is threaded through weight 136 through a central lumen thereafter threaded through seal 134, and lastly through central opening in outer housing 132, therein maintaining a free guidewire proximal end 1 lOp.
  • Figure 4B provides a perspective schematic diagram of GI device 150 wherein guidewire proximal end 11 Op is left as a free end of guidewire 110. Most preferably proximal end 11 Op is used to anchor GI device 150, for example by associated with a portion of the GI tract prior to deployment.
  • anchoring may be provided within the GI tract or any portion thereof for example including but not limited to the oral cavity, teeth, esophagus, stomach, small intestine, large intestine, anus, colon or the like prior to deployment device 150.
  • anchoring may be provided outside the oral cavity for example on the cheek, head, neck, nose, torso, or any portion of the body. .
  • deployment of device 150 according to the present invention may be provided for in a plurality of optional methods for example by swallowing device 150, placing and/or delivering device 150 within a portion of the GI tract though a minimally invasive procedure such as gastrostomy.
  • Most preferably following deployment device 150 travels through the GI tract through movements of the GI tract for example peristalsis making its ways through the GI tract releasing therein guidewire 110.
  • Most preferably guidewire filament 1 10 is unwound through the GI tract most preferably from the inside out, from the inner filament surface to the outer filament surface of coreless bobbin 100.
  • Figure 4C provides a cross section view of device 150 comprising proximal assembly 130 and distal assembly 120 as previously described.
  • Figure 5A depicts a stage wise manner of an optional method for deploying a GI guidewire through the GI tract using device 150 according to the present invention, as illustrated in Figures 1-4.
  • stage 501 the proximal free end of guidewire 1 lOp of device 150 is anchored optionally to a portion of the GI tract, for example the mouth and/or stomach.
  • stage 502 device 150 of the present invention is released into the GI tract.
  • the device 150 deploys guidewire 1 10 through the GI tract allowing it to travel within the GI tract through involuntary innate peristalsis activity of the GI tract within which it is found.
  • stage 504 device 150 is allowed to exit via the anus through regular bowl movement leaving behind a guidewire throughout the GI tract.
  • Figure 5B depicts a stage wise manner of an optional method for
  • proximal stopper 102 is threaded with proximal end of guidewire 1 lOp filament source through an opening in said proximal stopper.
  • proximal stopper 102 is placed along the proximal end of a spooling axis 12p associated with a spooling machine.
  • distal stopper 104 is placed on the distal end of said spooling axis 12d.
  • axis 12 is loaded with a length of said guidewire filament 110 by spinning spooling axis 12 about its axis therein drawing said guidewire filament from guidewire filament source and winding said drawn wire filament along spooling ax 12 is between proximal stopper 102 and distal stopper 104.
  • the wound and/spun filament 110 is released therein forming a distal end of said guidewire filament.
  • distal housing 122 is placed over the distal end of spooling axis 12, optionally and preferably forming an intermediate distal assembly 200.
  • stage 522 separate the spooling axis 12 form the distal assembly 120 while applying a force between the proximal stopper 102 and the distal housing 122.
  • stage 524 the proximal assembly is attached to the distal assembly by threading proximal housing 132 and optional seal 134 and optional weight 136 onto the proximal end of guidewire 1 lOp.
  • stage 526 the distal and proximal assemblies 120 and 130 are preferably coupled to form device 150.
  • Subjects 4 domestic female pigs as follows: subject number 2362 weighing 41kg, subject number 2361 weighing 39kg, subject number 2360 weighing 39kg and subject number 2364 weighing 41 kg.
  • GI device capsules ( Figure 4) according to the present invention.
  • Two GI device capsules were assembled with guidewire filament having tensile pulling force of 4-5 grams, one GI device with guidewire filament having 5-6 gram tensile pulling force, and one GI device with guidewire filament having 7-8 gram tensile pulling force.
  • Each of the four GI device capsules were assembled and loaded with the coreless guidewire bobbin according to optional embodiments of the present invention using a softbond 60 guidewire filament of about 14 meters in length. .
  • the Endoscope was inserted into the stomach identifying the trans-illumination of abdominal wall.
  • a gastrostomy was performed to place the GI device, for example device 150 as descried in figure 4, within the GI tract of subject, namely in the stomach.
  • Gastrostomy was performed by inserting a 12 gauge needle into the stomach through the abdominal wall under direct vision of endoscope.
  • the endoscope was loaded with the alligator tool externally through the Endoscope's working channel until the alligator tip protruded from the tip of the endoscope.
  • the process of anchoring the GI device capsule was initiated by externally grasping and holding the proximal end of the guidewire filament (11 Op) with the alligator tool.
  • the endoscope and proximal tip 110 were inserted into the stomach where the proximal guidewire filament (11 Op) was threaded into the lumen of the 12 Gauge needle until guidewire proximal tip 1 lOp was identified externally and held manually on the surface of the abdominal wall while the 12 gauge needle was withdrawn.
  • the endoscope was loaded with the GI device 150 externally within the net of a Roth net® associated within the endoscope's working channel. The loaded endoscope was re-inserted into the stomach and the capsule 150 released form the Roth net® where it was released within the lumen of the stomach. .
  • GI device 150 Once GI device 150 was loaded, anchoring was completed by suturing the guidewire proximal end (1 1 Op) to subcutaneous tissue with a Dexon-1 suture and further anchored to the external abdominal skin surface with Dexon 3-0 sutures. Synthomycine ointment was topically applied at the gastrostomy site. Following the procedure subjects received intravenous administration of Metocolpramide lOmg and 1 liter IV normal saline to replenish fluid balance, thereafter the subjects underwent a 12 hour NPO period followed by a regular diet.
  • One of the four subjects tested was tested for unassisted (natural) removal of the GI guidewire (1 10) from the GI tract. This procedure was performed once the guidewire lined the length of the GI tract.
  • the GI device 150 was unanchored from its anchoring locations along the abdominal wall and subcutaneous tissue by removing the appropriate suture.
  • a 4-5 gram capsule was introduced into subject 2362 using the procedure described above.
  • the stomach was full of food and therefore washed with extra water before introducing the needle through abdomen during the gastrostomy. After puncturing the abdomen there was slight bleeding that stopped spontaneously.
  • a 5-6 gram capsule was introduced into subject number 2361 according to the experimental procedures described above with slight alteration.
  • the string was inadvertently cut by about 20cm, rendering the guidewire loose within the stomach.
  • a second abdominal wall puncture was performed to retrieve the guidewire proximal end 11 Op and anchored at the second puncture location as described above. Due to the additional abdominal puncture an additional dose of 500mg of Amoxicillin I.M. was given and 1 liter of saline until3 waking.
  • a 7-8 gram capsule was used with subject 2360. Same procedure as described above. The Stomach was full with content and washing and suctioning was performed prior to gastrostomy.
  • a 4-5gram capsule was used with subject 2364 Subject follow up.
  • Subject 2364 expelled capsule 3days following gastrostomy and device deployment; subjects 2361 and 2362 expelled the capsule 4 days following gastrostomy ; and subject 2360 expelled the capsule 5 days following gastrostomy.
  • the subjects were examined on day 6 following gastrostomy. It was observed and noted that guidewire 1 10 protruded out of the anus in all 4 subjects.
  • mid-abdominal sections were done on day 6 following gastrostomy where digestive organs were identified. There was minimal free air in the peritoneum (presumably from the gastrostomy procedure), and the left lobe of the liver was punctured by the gastrostomy needle and wire in subjects 2361 and 2362. In subject 2364 the liver wasn't punctured.
  • the intestine appeared macroscopically normal in all animals and no evidence of peritonitis was seen macroscopically in any of the animals. Subsequently, sectioning of stomach, Duodenum, jejunum and ileum, spiral colon and rectum were performed in subjects 2361, 2362, and 2634.
  • the guidewire was found to continuously extend from its anchoring location in the stomach, wall to the rectum. The guidewire coursing on the mesenteric side of the intestine.
  • the stomach, colon and rectum appeared normal in all animals. In the small intestine, there was mild thickening of the mesenteric attachment to the bowel in some segments.
  • a linear indentation mark of the string was identified in the mucosa of some but not all intestinal segments, and in two of these it was accompanied by linear erythema and edema. The serosa was intact 5 in all these segments and no evidence for perforation noted.
  • subject 2360 weighed was 42kg increase 3kgfrom onset of experiment.

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Abstract

La présente invention concerne un dispositif et des procédés permettant de déployer un fil guide gastro-intestinal en bobine à travers le tractus gastro-intestinal et un procédé de fabrication du dispositif.
PCT/IL2011/000111 2010-01-31 2011-01-31 Dispositif de déploiement d'un fil guide en bobine, procédé de guidage de celui-ci à travers le tractus gastro-intestinal et procédé de fabrication associé WO2011092707A1 (fr)

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US30001610P 2010-01-31 2010-01-31
US61/300,016 2010-01-31

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105877860A (zh) * 2015-02-16 2016-08-24 李哲宰 双手使用的牙间清洁装置

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CN105877860A (zh) * 2015-02-16 2016-08-24 李哲宰 双手使用的牙间清洁装置

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