Medical Device, Method And System For Temporary Occlusion Of An Opening In A Lumen Of A Body

Abstract

A medical system is disclosed that has three basic components; a retractable sheet, a first balloon that has a centrally arranged hollow, and a collapsible/expandable support structure at the hollow. The first balloon is for instance mounted/molded onto the exterior surface of the support structure. The aggregate of support structure and the first balloon is positioned, and once the sheet has been retracted from the first balloon, the first balloon is inflated. The support structure may be self-expandable or expandable by an expansion unit, such as a further balloon arranged at its inside. The lumen of the support structure is chosen to be smaller than that of a main lumen. The outside diameter of the inflated first balloon is chosen to be larger than the interior diameter of the main lumen. This procedure may be done using standard Seldinger technique and fluoroscopy. This makes the system user friendly and increases patient safety, as a well established clinical method may be used with some modifications according to the invention.

1 . A medical device for temporarily provide sealing off a communication between a high flow main lumen of a body into an opening in a wall of said main lumen at a site inside said body, said medical device comprises a delivery system, wherein said medical device is and remains proximally affixed to said delivery system and is collapsible and expandable for transluminal delivery to and from said site, and comprises an aggregate of:
 a) a first inflatable balloon having a longitudinal dimension that extends substantially between a proximal end and a distal end thereof, a radially inner wall and a radially outer wall at a radial distance therebetween when said first balloon is in an inflated state in which said balloon at said inner wall has a natural inner inflated diameter and surrounds an inner hollow for providing a longitudinal fluid flow passage through said inner hollow along said main lumen and past said opening, and when in said inflated state said outer wall of said first balloon is in at least partly apposition to said wall of said main lumen at said site; and   b) at least one collapsible and expandable support structure having an expanded diameter, longitudinally arranged from said proximal end and to within said distal end of said first balloon, and radially arranged at said inner wall, whereby said support structure, when in an expanded state, supports a patency of said inner hollow of said first balloon at least in said inflated state thereof;   wherein said expanded diameter is larger than said inner inflated diameter, and said radial distance is substantially smaller than said inner inflated diameter;   in such a manner that said device substantially keeps a passage of said fluid through said main lumen open and to sealingly shuts off communication through said opening when said device is deployed at said site and said medical device not comprising an agent delivery port for delivery of an agent into said opening.   
     
     
         2 . The medical device according to  claim 1 , wherein said inner wall and outer wall are coaxially arranged in relation to each other and said inner hollow is centrally arranged within said inner wall, and
 wherein said support structure is a tubular support structure comprising a generally cylindrical body arranged at an inner wall boundary of said first balloon to said hollow center; and wherein said support structure is positioned coaxially with said first balloon in said hollow center at said inner boundary of said first balloon.   
     
     
         3 . The medical device according to  claim 1 , wherein said support structure is self expandable and said expanded diameter is a natural relaxed expanded diameter, wherein said support structure has a diameter that is smaller than said natural relaxed expanded diameter when said first balloon is inflated, whereby said support structure adapt a radially outwardly oriented force when said first balloon is inflated. 
     
     
         4 . The medical device according to  claim 1 , comprising a second balloon, wherein said support structure is balloon expandable by said second balloon that expands said tubular support to said expanded diameter and at least partly arranged inside said inner of said first balloon, wherein said second balloon is longitudinally at least extending between said proximal end and distal end of said support structure. 
     
     
         5 . The medical device according to  claim 4 , wherein a first inflation lumen is associated with said first balloon and a second inflation lumen associated with said second balloon; wherein said first and second inflation lumina are in fluid communication with each other, for simultaneous inflation of both the first and second balloon; or wherein said first and second inflation lumina are not in fluid communication with each other, for individual inflation of both the first and second balloon. 
     
     
         6 . The medical device according to  claim 4 , wherein said second balloon has a longitudinal dimension and a hollow center for providing a passage through said hollow center of said second balloon when said second balloon is in an inflated state. 
     
     
         7 . The medical device according to  claim 4 , wherein said second balloon is arranged to be deflated and retracted upon expanding said support structure. 
     
     
         8 . The medical device according to  claim 4 , wherein said second balloon has a section with larger diameter in at least one end portion thereof for expanding said support structure in sections with different diameters. 
     
     
         9 . The medical device according to  claim 1 , wherein said support structure is attached to said inner wall of said first balloon on an outside wall surface of a said inner hollow. 
     
     
         10 . The medical device according to  claim 1 , wherein said support structure is integral with said inner wall of said first balloon, in particular at least along a portion molded to each other. 
     
     
         11 . The medical device according to  claim 1 , wherein said support structure is attached to said inner wall of said first balloon on an inside wall surface thereof inside said first balloon. 
     
     
         12 . The medical device according to  claim 1  wherein said support structure comprises a mesh of wires. 
     
     
         13 . The medical device according to  claim 1  wherein said support structure comprises a pattern of struts and connectors. 
     
     
         14 . The medical device according to  claim 13 , wherein said device is collapsible without substantially expanding in length. 
     
     
         15 . The medical device according to  claim 1 , said support structure comprising a plurality of radial support webs. 
     
     
         16 . The medical device according to  claim 1 , comprising a second balloon, wherein a length of said support structure and a length of said second balloon if arranged therein, is larger than a length of said longitudinal dimension of said first balloon. 
     
     
         17 . The medical device according to  claim 16 , wherein said proximal end and/or distal end of said support structure is constructed such that it is expandable to a greater outer diameter a portion thereof at said inner hollow of said first balloon. 
     
     
         18 . The medical device according to  claim 17 , wherein said proximal end and/or distal end of said support structure is outwardly flared towards said outer wall of said first balloon and oriented away from said proximal end and/or distal end of said first balloon respectively. 
     
     
         19 . The medical device according to  claim 1 , wherein said support structure comprises a proximal extension radially arranged outwardly and at a distance from a longitudinal axis of said device and extending proximally longitudinally beyond said proximal end of said first balloon in said expanded state. 
     
     
         20 . The medical device according to  claim 19 , wherein said proximal extension comprises a cover or fluid tight layer or coating for tissue friendly contacting an inner tissue wall of said main lumen proximally said first balloon, such that a fluid guide into said inner hollow of said first balloon is provided upon expansion of said support structure. 
     
     
         21 . The medical device according to  claim 1 , wherein said support structure comprises a distal extension radially arranged outwardly and at a distance from a longitudinal axis of said device and extending distally longitudinally beyond said distal end of said first balloon in said expanded state. 
     
     
         22 . The medical device according to  claim 21 , wherein said distal extension comprises a cover or fluid tight layer or coating for tissue friendly contacting an inner tissue wall of said main lumen distally said first balloon, such that a fluid guide into said inner hollow of said first balloon is provided upon expansion of said support structure. 
     
     
         23 . The medical device according to  claim 19 , wherein a longitudinal extension of said support structure has a heat set shape to an extension of an outer diameter of said first balloon. 
     
     
         24 . The medical device according to  claim 1 , wherein said first balloon has a balloon body of elongate torus shape when inflated. 
     
     
         25 . The medical device according to  claim 1 , wherein said outer wall of said first balloon is at least partly devised for soft tissue apposition to an inner wall of said main lumen at a first portion of said outer wall, such that said device is configured to securely and sealingly engage said main lumen, 
     
     
         26 . The medical device according to  claim 1 , wherein said outer wall and said inner wall of said first balloon have sections of different rigidity. 
     
     
         27 . The medical device according to  claim 26 , wherein said different rigidity is provided by different wall thicknesses of said sections of said outer wall and said inner wall. 
     
     
         28 . The medical device according to  claim 27 , wherein said outer wall of said first balloon has proximal and distal end portions that have a wall thickness that is larger than a wall thickness at said first portion of said outer wall. 
     
     
         29 . The medical device according to  claim 1 , wherein a ratio of a maximum outer diameter of said first balloon in relation to maintained passage lumen diameter of said inner hollow is in the range of 40% to 90%. 
     
     
         30 . The medical device according to  claim 29 , wherein said ratio is larger than 75% up to 90%, such as 80%, 85%, or 90%. 
     
     
         31 . The medical device according to  claim 1 , comprising a locking function for releasably locking said support structure in said expanded state. 
     
     
         32 . The medical device according to  claim 1 , wherein said aggregate is radial flexible upon expansion. 
     
     
         33 . The medical device according to  claim 1 , wherein said device comprises radiopaque markers, and/or wherein said balloon is inflatable with radiopaque material, or wherein said balloon is filled with radiopaque material when inflated. 
     
     
         34 . The medical device according to  claim 1 , wherein said lumina are blood vessels, said outer wall is arrangable to sealingly cover an ostium of a branch lumen at said site, and said first balloon is inflatable over an extended period of time for occluding said ostium to said side branch vessel during a surgery of an organ supplied with blood by said side branch vessel. 
     
     
         35 . The medical device according to  claim 1 , wherein said aggregate is re-collapsible after expansion, such that said device is transluminally removable from said site and out of said body upon a time of occlusion of said flow through said opening. 
     
     
         36 . The medical device according to  claim 1 , wherein a unidirectional flow unit is arranged in said inner hollow. 
     
     
         37 . A medical system devised for temporary closure of an opening of a main lumen of a body at a site inside said body, the system comprising:
 at least one aggregate according to any of  claims 1  to  36  and a catheter comprising a catheter shaft and a catheter sheath; wherein   said aggregate of said medical device is associated with said catheter shaft at a distal end portion thereof, and wherein:   said catheter sheath is arranged to restrict expansion of said aggregate when positioned in said catheter sheath, and wherein   said catheter sheath is retractable from said catheter shaft to allow expansion of said aggregate at said site for said temporary closure; and/or.   an expansion unit arranged to provide an active expansion of the support structure upon delivery.   
     
     
         38 . The medical system according to  claim 37 , wherein said catheter shaft comprises a guidewire lumen for passage of a guidewire to position the catheter within the main lumen at said site, and at least one inflation lumen for inflating at least said first balloon; and wherein said system furthermore comprises a guidewire arranged in said guidewire lumen. 
     
     
         39 . A kit of at least two aggregates according to  claim 1 , wherein said aggregates are spaced apart from each other and interconnected to each other by a fluid leakage tight interconnection unit adapted to provide a through-flow of fluid between inner hollows of first balloons of said medical devices. 
     
     
         40 . The kit according to  claim 39 , wherein said interconnection unit is a tubular interconnection unit having a fluid tight tubular wall between a proximal end and a distal end of said tubular interconnection unit, wherein said proximal end of said tubular wall is connected to a distal opening of said inner hollow of a proximal of said aggregates, and wherein said distal end of said tubular wall is connected to a proximal opening of said inner hollow of a distal of said aggregates in order to provide a fluid channel between said inner hollows. 
     
     
         41 . The kit according to  claim 40 , wherein
 said proximal of said aggregates is positionable proximally of an ostium of said branch lumen into said main lumen, and   said distal of said aggregates is positionable distally of said ostium, and wherein said   tubular wall is non-elastic and flexible and arrangable along said ostium, in said main lumen and at a distance from said ostium, without contacting tissue of said main lumen, ostium or branch lumen.   
     
     
         42 . The kit according to  claim 40 , wherein said wall comprises reinforcement structure. 
     
     
         43 . A method for temporary occluding a fluid flow from a main lumen of a body through an opening in said main lumen at a site inside said body, wherein said method comprises
 transluminally delivering a medical occlusion device, being affixed to a delivery system, in a collapsed state thereof to said site, and   expanding said medical occlusion device at said site at least partly by   inflating a first inflatable balloon of said medical occlusion device substantially between a proximal end and a distal end thereof, thus   appositioning an outer wall of said first balloon at least partly to an inner wall of said main lumen at said site, and   keeping open a passage of said fluid in said main lumen through a inner hollow of said first inflatable balloon interior of an inner wall thereof, and thus   substantially sealing off a passage of said fluid into said branch lumen when said medical occlusion device is deployed at said site, and providing a longitudinal fluid flow through said inner hollow, and after an occlusion time and transluminally retracting said re-collapsed medical occlusion device from said site.   
     
     
         44 . The method according to  claim 43 , comprising
 radially expanding a support structure, longitudinally from said proximal end and to within said distal end of said first balloon, at an inner wall of said first balloon, thus supporting a patency of said inner hollow by said support structure.   
     
     
         45 . The method according to  claim 44 , wherein said expanding said support structure comprises inflating a second balloon at least partly arranged inside side inner hollow and said support structure. 
     
     
         46 . The method according to  claim 44 , comprising expanding said support structure to a diameter smaller than that of the main lumen. 
     
     
         47 . The method according to  claim 43 , wherein said inflating said first balloon comprises inflating said first balloon to an outside diameter larger than an interior diameter of the main lumen. 
     
     
         48 . The method according to  claim 43 , comprising performing said delivering and retracting by using a standard Seldinger technique and fluoroscopy. 
     
     
         49 . The method according to  claim 44 , comprising concurrently inflating said first and second balloon via a common inflation lumen. 
     
     
         50 . The method according to  claim 44 , comprising individually inflating said first and second balloon via separate inflation lumina. 
     
     
         51 . The method according to  claim 50 , comprising sequentially inflating said first balloon and then said second balloon. 
     
     
         52 . The method according to  claim 43 , comprising arranging said outer wall to sealingly cover an ostium of a branch lumen at said site, and keeping said first balloon inflated over an occlusion period of time for occluding said ostium. 
     
     
         53 . The method according to  claim 43 , comprising positioning at least two medical occlusion devices at said site spaced apart from each other, and interconnecting said medical devices to each other by a fluid leakage tight interconnection unit adapted, thus providing a through-flow of fluid between inner hollows of first balloons of said medical devices. 
     
     
         54 . The method according to  claim 53 , comprising providing said through-flow through a fluid channel of a tubular interconnection unit having a fluid tight tubular wall between a proximal end and a distal end of said tubular interconnection unit, wherein said proximal end of said tubular wall is connected to a distal opening of said inner hollow of a proximal of said medical devices, and wherein said distal end of said tubular wall is connected to a proximal opening of said inner hollow of a distal of said medical devices in order to provide a fluid channel between said inner hollows. 
     
     
         55 . The method according to  claim 54 , said positioning at least two medical occlusion devices at said site spaced apart from each other comprising
 positioning a proximal medical occlusion device of said at least two medical occlusion devices proximally of an ostium of said branch lumen into said main lumen, and   positioning a distal medical occlusion device of said medical devices distally of said ostium, and   arranging said tubular wall along said ostium, in said main lumen, and at a distance from said ostium, without contacting tissue of said main lumen, ostium or branch lumen.   
     
     
         56 . The method according to  claim 43 , wherein said lumen is a blood vessel, said method comprising performing a surgery of an organ supplied with blood by said side branch lumen during at least a part of said occlusion period of time. 
     
     
         57 . The method according to  claim 43 , wherein said medical occlusion device is a medical device comprised in any of  claims 1  to  36 . 
     
     
         58 . The method according to  claim 43 , wherein said opening is an opening to a branch lumen of said main lumen at a branch site, or an abnormal opening of said wall of said main lumen, or an aneurysm of said wall of said main lumen. 
     
     
         59 . The method according to  claim 43 , further comprising actively expanding said support structure. 
     
     
         60 . The method according to  claim 43 , wherein said method is a passive intervention.