Body passage cleansing device

{
  "publication_number": "US9333287B2",
  "country": "US",
  "kind": "B2",
  "title": "Body passage cleansing device",
  "abstract": "The present invention provides a body passage cleansing device suitable for being passed through an internal channel of an endoscope, comprising a distal plug having a proximal end and a distal end, wherein said plug comprises channels, apertures and/or nozzles which are capable of allowing the passage of a fluid therethrough from said proximal end to said distal end, wherein said plug is connected to the distal end of a wire or other actuating means; wherein at least an outer portion of said distal plug is capable of being elastically deformed such that the external diameter and/or outline thereof may be reduced in response to inwardly-directed compression forces exerted thereon; and wherein said channels, apertures and/or nozzles are in a closed conformation when said distal plug is subject to said compression forces, and in an open conformation when said plug is not subject to said compression forces.",
  "claims": [
    "1. A device suitable for being passed through an internal channel of an endoscope, comprising at least one distal plug having a plurality of apertures which are capable of allowing the passage of a fluid therethrough, wherein said distal plug is connected to a distal end of an actuating element; wherein at least an outer portion of said distal plug is capable of being elastically deformed such that an external diameter thereof may be reduced in response to inwardly-directed compression forces exerted thereon from the inside of the internal channel of the endoscope as the actuating element moves inwardly in the internal channel of the endoscope closing the plurality of apertures to flow of the fluid when the apertures are in a closed conformation; and wherein said apertures are in an open conformation when said distal plug is not subject to said compression forces when the actuating element and distal plug extends out of the internal channel of the endo scope, said fluid being capable of passing through said apertures when said apertures are in said open conformation.",
    "2. The device according to claim 1, wherein the actuating element is a wire.",
    "3. The device according to claim 1, wherein the external diameter of the distal plug when not subjected to inwardly-directed radial compression forces is slightly larger than the internal diameter of an endoscope working channel.",
    "4. The device according to claim 1, wherein the distal plug comprises an O-ring.",
    "5. The device according to claim 1, further comprising a tube surrounding the actuating element in a coaxial manner, wherein said tube extends from the proximal end of said actuating element; and wherein the length of said tube is less than the length of said actuating element, such that a portion of the distal region of said actuating element is left unenclosed by said tube.",
    "6. The device according to claim 5, further comprising a partial length outer tube disposed such that it surrounds an inner tube and actuating element in a coaxial manner.",
    "7. The device according to claim 5, further comprising a proximal control handle, wherein the proximal end of the tube is connected to said handle; wherein the proximal end of the actuating element is movably connected to said handle; wherein said handle comprises means for changing the distance between said handle and the distal end of said actuating element; wherein said handle comprises one or more passages for connecting a fluid-supply channel to one of two or more fluid outlet channels; and wherein said handle comprises means for switching between the fluid outlet channels to which said fluid-supply channel is connected.",
    "8. The device according to claim 7, wherein the handle comprises one fluid outlet channel in fluid communication with the lumen of the tube, and a second fluid outlet channel in fluid communication with the space surrounding the external surface of said tube.",
    "9. The device according to claim 7, wherein the means for changing the distance between the handle and the distal end of the actuating element comprises a slider.",
    "10. The device according to claim 6, further comprising a proximal control handle, wherein the proximal ends of both the inner and outer tubes are connected to said handle; wherein the proximal end of the actuating element is movably connected to said handle; wherein said handle comprises means for changing the distance between said handle and the distal end of said actuating element; wherein said handle comprises switching means for directing the output of a fluid-supply channel to one or more fluid outlet channels; and wherein said handle comprises coupling means for coordinating the aforementioned switching between the fluid outlet channels with said means for changing the distance between said handle and the distal end of the actuating element.",
    "11. The device according to claim 10, wherein the switching means comprises a multi-way fluid valve.",
    "12. A system for cleansing body passages comprising: a) a device according to claim 1; b) an aspiration pump; c) an irrigation pump; d) relays, transformers and computer equipment for controlling the functioning of said device and pumps.",
    "13. A method for cleansing a body passage comprising: a) inserting an elongate medical device into said body passage such that the distal end thereof becomes located close to, and on the proximal side of, the area of said passage to be cleansed; b) passing a distal plug comprising a plurality of deformable, radially extending projections defining apertures therebetween through an internal channel of said elongate medical device such that said distal plug becomes located beyond a distal exit of said internal channel and in contact with the distal face of said medical device; the apertures being closed when inside the internal channel of said elongate medical device; c) introducing irrigation fluid into said internal channel at a pressure that is sufficient to cause said fluid to form a spray or jet upon passing through the apertures formed in said distal plug when said apertures are out of the internal channel of said elongate medical device; d) allowing said spray or jet to cleanse the region of the body passage that is situated immediately distal to the end of said internal channel; e) causing said distal plug to move distally such that there is no contact between said distal plug and the distal face of said elongate medical instrument within the body passage; f) applying a negative pressure to a proximal end of the internal channel of the elongate medical instrument, in order to cause aspiration of fluid and solid particulate matter through said internal channel; g) if necessary, bringing said distal plug back to the location defined in step (b) and repeating steps (c) to (f).",
    "14. The method of claim 13, wherein the elongate medical instrument is an endoscope and wherein the internal channel is a working channel contained therein.",
    "15. The method of claim 14, wherein the endoscope is a colonoscope and the body passage to be cleansed is a portion of the large intestine.",
    "16. The method according to claim 13, wherein the distal plug is attached to a guidewire.",
    "17. The method according to claim 16, wherein the guidewire is surrounded by a partial length inner tube that extends distally from the proximal end of said guidewire, and wherein the length of said tube is less than the length of said wire, such that a portion of the distal region of said wire is left unenclosed by said tube.",
    "18. The method according to claim 17, wherein the partial length inner tube is surrounded coaxially by a partial length outer tube.",
    "19. The method according to claim 17, further comprising the steps of: i) withdrawing the distal plug into the distal end of the internal channel such that said distal plug is radially compressed, thereby causing its external diameter to be reduced, thereby sealing the distal end of said internal channel; ii) introducing irrigation fluid into the lumen of the partial length tube such that when said fluid leaves the distal end of said tube, the positive fluid pressure provided thereby assists in preventing or removing blockages in the distal portion of the internal channel of the elongate medical device.",
    "20. A method for cleansing a body passage comprising: a) inserting an elongate medical device into said body passage such that the distal end thereof becomes located close to, and on the proximal side of, the area of said passage to be cleansed; b) passing a device comprising a distal head spray unit comprising a plurality of deformable, radially extending projections defining a plurality of apertures therebetween through an internal channel of said elongate medical device, wherein said distal head spray unit is connected to a distal end of a collapsible catheter and to a distal end of an associated stiffening wire, such that said distal spray head unit becomes located beyond a distal exit of said internal channel; the plurality of apertures being closed when inside of said internal channel of the elongate medical device; c) introducing irrigation fluid into the lumen of said collapsible catheter at a pressure that is sufficient to cause said fluid to form a spray or jet upon passing through the apertures formed in said distal spray head unit when said apertures are out of the internal channel of the elongate medical device; d) allowing said spray or jet to cleanse the region of the body passage in which said distal spray head unit is located; e) closing a supply of irrigation fluid to the lumen of said collapsible catheter, and optionally applying a negative pressure to a proximal opening of said lumen, such that the walls of said catheter collapse thereby decreasing the volume of the internal channel occupied by said catheter; f) applying a negative pressure to a proximal end of the internal channel of the elongate medical instrument, in order to cause aspiration of fluid and solid particulate matter through said internal channel; g) if necessary, repeating steps (c) to (f).",
    "21. The device according to claim 1, wherein said distal end of said distal plug comprises a plurality of deformable, radially extending projections that define said apertures therebetween such that said apertures are each spaced apart from one another.",
    "22. The device according to claim 21, wherein said distal end of said distal plug comprises a rigid portion defining a distally-facing dome and said distal end of said distal plug comprises a deformable, angled skirt-like element, said skirt-like element being connected to said dome by a cylindrical element.",
    "23. The device according to claim 22, wherein said cylindrical element has a maximum width that is less than that of said skirt-like element and said dome.",
    "24. The device according to claim 22, wherein said skirt-like element has a convex portion that faces a common direction with a convex portion of said dome.",
    "25. The device according to claim 23, wherein said apertures extend through said convex portion of said skirt-like element.",
    "26. The device according to claim 22, wherein said skirt-like element that has a first convex portion that faces a common direction with a convex portion of said dome and a second convex portion that faces opposite the common direction.",
    "27. The device according to claim 26, wherein said apertures extend through said first convex portion.",
    "28. The device according to claim 22, wherein said apertures are configured to spray said fluid radially outward from said cylindrical element as said fluid passes through said apertures.",
    "29. The device according to claim 22, wherein an O-ring is fitted on said cylindrical element.",
    "30. A device suitable for being passed through an internal channel of an endoscope, comprising: at least one plug having a proximal end and a distal end, said proximal end of said plug being connected to a wire of an actuating element, said distal end of said plug comprising a plurality of deformable, radially extending projections that define apertures therebetween, said apertures being spaced apart from one another, wherein at least an outer portion of said plug is capable of being elastically deformed such that an external diameter of said plug may be reduced in response to inwardly-directed compression forces exerted thereon, said apertures being in a closed conformation when said distal plug is subject to said compression forces when said apertures is inside the internal channel of the endoscope, and in an open conformation when said plug is not subject to said compression forces when said aperture is out of the internal channel of the endoscope.",
    "31. The device according to claim 30, wherein said distal end of said plug comprises a rigid portion defining a distally-facing dome and said distal end of said plug comprises a deformable, angled skirt-like element, said skirt-like element being connected to said dome by a cylindrical element."
  ],
  "description_excerpt": "This application is a Continuation-In-Part of International Application No. PCT/IL2009/000346, filed 26 Mar. 2009, which designated the U.S. and claims the benefit of US Provisional Application Nos. 61/043,136, filed 8 Apr. 2008; and U.S. Provisional Application No. 61/078,873 filed 8 Jul. 2008, the application also hereby claims priority on U.S. Provisional Application No. 61/298,265, the entire contents of which is hereby incorporated by reference.\n\nThe present invention relates to a device for cleaning the lumen of the colon or other body cavity. More specifically, said device is constructed such that it permits both optimal irrigation of the body passage and large-volume aspiration of the irrigation fluid and debris.\n\nDuring endoscopic procedures the physician inserts a flexible endoscope manually and navigates the device by visualizing the internal path using the integrated camera. In Colonoscopy, despite the use of various pre-colonoscopy cleansing regimes, in many cases the operator's field of view is severely restricted by fecal debris and other particulate matter that is left behind in the colonic lumen or other body passage.\n\nVarious attempts have been made to provide procedures and means for washing the colonic lumen prior to performing a colonoscopic investigation. The diagnostic accuracy and the therapeutic safety of colonoscopy (as well as of other diagnostic/therapeutic procedures such as virtual colonoscopy, sigmoidoscopy, barium enemas and pill camera) depend, to a large extent, on the quality of the colonic cleansing or preparation.",
  "cpc": [
    "A61M 3/0283",
    "A61B 1/00068",
    "A61B 1/12",
    "A61M 1/0064",
    "A61M 3/0295"
  ],
  "ipc": [
    "A61M 25/00",
    "A61M 1/00",
    "A61M 3/02",
    "A61B 1/00",
    "A61M 31/00"
  ],
  "assignees": [
    "Jet Prep Ltd"
  ],
  "inventors": [
    "David Nitsan",
    "Shay Dubi",
    "Nadav BEN-DA'AT",
    "Anat KEREM-ANGEL",
    "Jacek Krzyzanowski"
  ],
  "filing_date": "2010-10-07",
  "publication_date": "2016-05-10",
  "grant_date": "2016-05-10",
  "priority_date": "2008-04-08",
  "application_number": "US-92379610-A",
  "family_id": "44318740",
  "cited_by_count": 17,
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}