Shunt device and a method for shunting cerebrospinal fluid

Abstract

A shunt device for shunting cerebrospinal fluid (CSF) from a CSF containing space to a sinus system cavity comprises a tubular inlet element, a flow restricting part, and a tubular outlet element having an outlet end with an outlet opening for insertion in the sinus system cavity, and a one-way valve preventing flow in a direction from the outlet opening to the inlet opening. The shunt device further comprises a distancer, said distancer being provided at the outlet end of the tubular outlet element.

1 . A shunt device, comprising:
 a tubular inlet element having an inlet end with an inlet opening and an inner lumen extending through tubular inlet,   a tubular outlet element having an outlet end with an outlet opening and an inner lumen extending through the tubular outlet;   a shunt body, the inner lumen of the tubular inlet element and the inner lumen of the tubular outlet element being operably connected to each other through the shunt body;   a distancer attached at the outlet end of the tubular outlet element or at an end portion of the tubular outlet element that includes the outlet end,   wherein the distancer is compactable into a compacted state, and expandable into at least one expanded state;   wherein the distancer is in one of the at least one expanded state unless an external force is applied to compact the distancer into a compacted state; and   wherein the distancer is configured to maintain the outlet end substantially at a central position of a sinus system cavity when the tubular outlet element is inserted into the sinus system cavity.   
     
     
         2 . The shunt device according to  claim 1 , wherein the distancer is configured to prevent the outlet end from contacting surrounding endothelial tissue when the tubular outlet element is inserted into the sinus system cavity. 
     
     
         3 . (canceled) 
     
     
         4 . The shunt device according to  claim 1 , wherein the outlet end is maintained in a position substantially parallel to a direction of fluid flow in the sinus system cavity. 
     
     
         5 . The shunt device according to  claim 4 , wherein the direction of flow of cerebrospinal fluid (CSF) exiting the outlet end is substantially parallel to the direction of fluid flow in the sinus system cavity. 
     
     
         6 . The shunt device according to  claim 1 , wherein the orientation of the outlet end is substantially parallel to a central, longitudinal axis of the distancer. 
     
     
         7 . (canceled) 
     
     
         8 . The shunt device according to  claim 1 , wherein the distancer is integral with the outlet end of the tubular outlet element. 
     
     
         9 . The shunt device according to  claim 1 , wherein the distancer comprises at least three distance keepers, each being positioned at a distance from the tubular outlet element in a direction perpendicular to a central longitudinal axis of the outlet end of the tubular outlet element. 
     
     
         10 . The shunt device according to  claim 9 , wherein each distance keeper forms part of a distance member protruding from the tubular outlet element in a direction away from the central longitudinal axis. 
     
     
         11 . The shunt device according to  claim 9 , wherein said at least three distance keepers are positioned equidistantly from one other. 
     
     
         12 . The shunt device according to  claim 11 , wherein said at least three distance keepers and/or distance members are positioned in a fashion satisfying the equation α+β−γ=360°, where α, β and γ represent non-overlapping angles between two distance keepers and/or distance members when seen in the direction of the central longitudinal axis of the tubular outlet element, and where α>90°, β>90°, and γ>90°. 
     
     
         13 . The shunt device according to  claim 11 , further comprising connector members each interconnecting two or more of the at least three distance members in order to hinder tangential movement of the distance members when seen in the direction of the central longitudinal axis of the outlet end of the tubular outlet element. 
     
     
         14 . The shunt device according to  claim 9 , wherein the distancer comprises two or more sets of distance members, the distance members of one set being arranged to protrude from the tubular outlet element at a different distance from the outlet opening than the distance members of another set, wherein each set is positioned in a direction of the central longitudinal axis of the outlet end of the tubular outlet element. 
     
     
         15 . The shunt device according to  claim 1 , wherein the distancer comprises a resilient mesh comprising at least three distance keepers defining a maximum protrusion of the mesh from a central longitudinal axis of the outlet end of the tubular outlet element. 
     
     
         16 . The shunt device according to  claim 1 , wherein the distancer is attached to the outlet end of the tubular outlet element via one or more attachment members. 
     
     
         17 . (canceled) 
     
     
         18 . The shunt device according to  claim 1 , wherein the distancer comprises at least three distance keepers protruding from a central longitudinal axis of the outlet end of the sinus catheter. 
     
     
         19 . (canceled) 
     
     
         20 . A method of shunting cerebrospinal fluid (CSF) using a shunt device according to  claim 1 , the method comprising the steps of:
 a) inserting at least a part of the tubular inlet element comprising the inlet opening into a cerebrospinal fluid containing space of a patient,   b) inserting at least a part of the tubular outlet element comprising the outlet opening and the distancer in the compacted state into the sinus system cavity of the patient, wherein an external force is applied to compact the distancer from the one of the at least one expanded state into the compacted state during the insertion,   c) changing the state of the distancer from the compacted state to the one of the at least one expanded state, and   d) retractably fixating the tubular outlet element of the shunt device in the sinus system cavity.   
     
     
         21 .- 31 . (canceled) 
     
     
         32 . The shunt device according to  claim 1 , wherein the distancer is in the compacted state when the tubular outlet element is introduced into said sinus system cavity. 
     
     
         33 . The shunt device according to  claim 32 , wherein the distancer and the tubular outlet element do not penetrate endothelial tissue when the tubular outlet element is positioned in said sinus system cavity. 
     
     
         34 . The shunt device according to  claim 1 , wherein the distancer is in the compacted state when the tubular outlet element is introduced into a delivery catheter. 
     
     
         35 . The method of  claim 20 , comprising the further steps of
 e) retracting the tubular outlet element and the distancer in a retraction compacted state from said sinus system cavity, wherein an external force is applied for compacting the distancer from the expanded state into the retraction compacted state during the retraction, and   f) inserting a replacement tubular outlet element in said sinus system cavity by repeating steps b), c) and d) of the method of  claim 20  for the replacement tubular outlet element.   
     
     
         36 . The method of  claim 20 , wherein neither the distancer nor the tubular outlet element are penetrating endothelial tissue when the tubular outlet element is positioned in said sinus system cavity. 
     
     
         37 . The method of  claim 20 , wherein the distancer is in the compacted state when the tubular outlet element is introduced into a delivery catheter for delivering the tubular outlet element to the sinus system cavity. 
     
     
         38 . The shunt device according to  claim 1 , wherein the distancer is in the compacted state when the tubular outlet element is retracted from said sinus system cavity. 
     
     
         39 . The shunt device according to  claim 1 , wherein the tubular inlet element forms part of a brain ventricle catheter adapted for draining cerebrospinal fluid (CSF) from a brain ventricle to the shunt body, and wherein the tubular outlet element forms part of a sinus catheter adapted for draining cerebrospinal fluid from the shunt body to the sinus system cavity. 
     
     
         40 . The shunt device according to  claim 39 , wherein the sinus system cavity is sinus transversus or vena jugularis. 
     
     
         41 . The shunt device according to  claim 1 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening. 
     
     
         42 . The shunt device according to  claim 1 , wherein a tube inserted into the outlet opening of the outlet element provides resistance to the flow of cerebrospinal fluid (CSF) through the shunt device, wherein the shunt body does not have a flow restricting part. 
     
     
         43 . The shunt device according to  claim 1 , wherein the shunt body comprises a flow restricting part. 
     
     
         44 . The shunt device according to  claim 1 , wherein the shunt body comprises a one-way valve configured to prevent cerebrospinal fluid (CSF) from flowing from the outlet opening to the inlet opening. 
     
     
         45 . A shunt device, comprising:
 a tubular inlet element having an inlet end with an inlet opening, and an inner lumen extending through the tubular inlet element;   a tubular outlet element having an outlet end with an outlet opening, and an inner lumen extending through the tubular outlet element;   a shunt body, the inner lumen of the tubular inlet element and the inner lumen of the tubular outlet element being operably connected to each other through the shunt body; and   a distancer attached at the outlet end or at a portion of the tubular outlet element that includes the outlet end,   wherein the distancer is configured to maintain the outlet end substantially at a central position of a sinus system cavity when the tubular outlet element is inserted into the sinus system cavity.   
     
     
         46 . The shunt device according to  claim 45 , wherein the distancer is configured to prevent the outlet end of the tubular element from contacting surrounding endothelial tissue when the tubular outlet element is inserted into the sinus system cavity. 
     
     
         47 . The shunt device according to  claim 45 , wherein the tubular inlet element forms part of a brain ventricle catheter adapted for draining cerebrospinal fluid (CSF) from a brain ventricle to the shunt body, and wherein the tubular outlet element forms part of a sinus catheter adapted for draining cerebrospinal fluid from the shunt body to the sinus system cavity. 
     
     
         48 . The shunt device according to  claim 47 , wherein the sinus system cavity is sinus transversus or vena jugularis. 
     
     
         49 . The shunt device according to  claim 45 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening. 
     
     
         50 . The shunt device according to  claim 45 , wherein a tube inserted into the outlet opening of the outlet element provides resistance to a flow of cerebrospinal fluid (CSF) through the shunt device, wherein the shunt body does not have a flow restricting part. 
     
     
         51 . The shunt device according to  claim 45 , wherein the shunt body comprises a flow restricting part. 
     
     
         52 . The shunt device according to  claim 45 , wherein the shunt body comprises a one-way valve configured to prevent cerebrospinal fluid (CSF) from flowing from the outlet opening to the inlet opening. 
     
     
         53 . A shunt device, comprising:
 a tubular inlet element comprising an inlet end with an inlet opening, and an inner lumen extending through the tubular inlet element;   a tubular outlet element comprising an outlet end with an outlet opening, and an inner lumen extending through the tubular outlet element;   a shunt body, the inner lumen of the tubular inlet element and the inner lumen of the tubular outlet element being operably connected to each other through the shunt body; and   a distancer attached with an attachment member to the outlet end of the tubular outlet element or to a portion of the tubular outlet element that includes the outlet end, and having a central longitudinal axis coaxial with a central longitudinal axis of the outlet end of the tubular outlet element,   wherein the distancer is compactable into a compacted state, and expandable into at least one expanded state; and   wherein in the compacted state and in the at least one expanded state, the distancer extends from the attachment member beyond the outlet end.   
     
     
         54 . The shunt device according to  claim 53 , wherein the distancer is configured to prevent the outlet end of the tubular element from contacting surrounding endothelial tissue when the tubular outlet element is inserted into a sinus system cavity. 
     
     
         55 . The shunt device according to  claim 54 , wherein the outlet end is maintained substantially at a central position of the sinus system cavity when the tubular outlet element is inserted into the sinus system cavity. 
     
     
         56 . The shunt device according to  claim 53 , wherein the tubular inlet element forms part of a brain ventricle catheter adapted for draining cerebrospinal fluid (CSF) from a brain ventricle to the shunt body, and wherein the tubular outlet element forms part of a sinus catheter adapted for draining cerebrospinal fluid from the shunt body to a sinus system cavity. 
     
     
         57 . The shunt device according to  claim 56 , wherein the sinus system cavity is sinus transversus or vena jugularis. 
     
     
         58 . The shunt device according to  claim 53 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening. 
     
     
         59 . The shunt device according to  claim 53 , wherein a tube inserted into the outlet opening of the outlet element provides resistance to the flow of CSF through the shunt device, wherein the shunt body does not have a flow restricting part. 
     
     
         60 . The shunt device according to  claim 53 , wherein the shunt body comprises a flow restricting part. 
     
     
         61 . The shunt device according to  claim 53 , wherein the shunt body comprises a one-way valve configured to prevent cerebrospinal fluid (CSF) from flowing from the outlet opening to the inlet opening. 
     
     
         62 . A shunt device, comprising:
 a tubular inlet element having an inlet end with an inlet opening for insertion into a cerebrospinal fluid (CSF) containing space, and an inner lumen extending though the tubular inlet element;   a tubular outlet element having an outlet end with an outlet opening adapted for insertion into vena jugularis, and an inner lumen extending through the tubular outlet element;   a shunt body, the inner lumen of the tubular inlet element and the inner lumen of the tubular outlet element being operably connected to each other through the shunt body;   a distancer attached at the outlet opening or at a portion of the tubular outlet element that includes the outlet end of the tubular outlet element for maintaining the outlet end of the tubular outlet element at an essentially fixed distance from endothelial tissue surrounding said tubular outlet element when the shunt device is inserted into vena jugularis; and   a one-way valve positioned at an end of the tubular outlet element that is opposite the outlet end.   
     
     
         63 . The shunt device according to  claim 62 , wherein the distancer is configured to prevent the outlet end of the tubular element from contacting surrounding endothelial tissue when the tubular outlet element is inserted into vena jugularis. 
     
     
         64 . The shunt device according to  claim 63 , wherein the outlet end is maintained substantially at a central position of a sinus system cavity when the tubular outlet element is inserted into vena jugularis. 
     
     
         65 . The shunt device according to  claim 62 , wherein the tubular inlet element forms part of a brain ventricle catheter adapted for draining CSF from a brain ventricle to the shunt body, and wherein the tubular outlet element forms part of a sinus catheter adapted for draining CSF from the shunt body to vena jugularis. 
     
     
         66 . The shunt device according to  claim 62 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening. 
     
     
         67 . The shunt device according to  claim 62 , wherein a tube inserted into the outlet opening of the outlet element provides resistance to flow of CSF through the shunt device, wherein the shunt body does not have a flow restricting part. 
     
     
         68 . The shunt device according to  claim 62 , wherein the shunt body comprises a flow restricting part. 
     
     
         69 . The shunt device according to  claim 62 , wherein the one-way valve is configured to prevent CSF from flowing from the outlet opening to the inlet opening. 
     
     
         70 . The shunt device according to  claim 62 , wherein the one-way valve is positioned between the end of the tubular outlet element that is opposite the outlet end and an end of the tubular inlet element that is opposite the inlet end.