Shunt device and a method for shunting cerebrospinal fluid
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 brain ventricle catheter having an inlet end with an inlet opening and an inner lumen extending through the brain ventricle catheter,
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 including walls defining a chamber configured for subcutaneous placement of the shunt body on a calvarium of a patient, the inner lumen of the brain ventricle catheter 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 the compacted state;
wherein the distancer is configured to maintain the outlet opening substantially at a central position of a lumen of a sinus system cavity of the patient when the tubular outlet element is inserted into the sinus system cavity; and
wherein, when the shunt body is placed on the calvarium of the patient:
the brain ventricle catheter is shaped and sized to fluidly connect the shunt body with a brain ventricle of the patient when the inlet opening of the brain ventricle catheter is placed in the brain ventricle of the patient; and
the tubular outlet element is shaped and sized to fluidly connect the shunt body with the lumen of the sinus system cavity of the patient when the outlet end and the distancer are inserted into the lumen of the sinus system cavity of the patient and the inlet opening of the brain ventricle catheter is placed in the brain ventricle of the patient.
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 . 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.
4 . The shunt device according to claim 3 , wherein the direction of fluid flow of cerebrospinal fluid (CSF) exiting the outlet opening is substantially parallel to the direction of fluid flow in the sinus system cavity.
5 . 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.
6 . The shunt device according to claim 1 , wherein the distancer is integral with the outlet end of the tubular outlet element.
7 . 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.
8 . The shunt device according to claim 7 , 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.
9 . The shunt device according to claim 7 , wherein said at least three distance keepers are positioned equidistantly from one other.
10 . The shunt device according to claim 9 , 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, βand 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°.
11 . The shunt device according to claim 9 , 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.
12 . The shunt device according to claim 7 , 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.
13 . 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.
14 . 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.
15 . 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 tubular outlet element.
16 . 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.
17 . The shunt device according to claim 16 , 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.
18 . 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.
19 . 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.
20 . The shunt device according to claim 1 , wherein the brain ventricle catheter is adapted for draining cerebrospinal fluid (CSF) from the brain ventricle of the patient 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.
21 . The shunt device according to claim 20 , wherein the sinus system cavity is sinus transversus or vena jugularis.
22 . The shunt device according to claim 1 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening.
23 . The shunt device according to claim 1 , wherein a tube inserted into the outlet opening of the tubular 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.
24 . The shunt device according to claim 1 , wherein the shunt body comprises a flow restricting part.
25 . 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.
26 . A shunt device, comprising:
a brain ventricle catheter having an inlet end with an inlet opening, and an inner lumen extending through the brain ventricle catheter;
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 including walls defining a chamber configured for subcutaneous placement of the shunt body on a calvarium of a patient, the inner lumen of the brain ventricle catheter 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 opening substantially at a central position of a lumen of a sinus system cavity when the tubular outlet element is inserted into the sinus system cavity; and
wherein, when the shunt body is placed on the calvarium of the patient:
the brain ventricle catheter is shaped and sized to fluidly connect the shunt body with a brain ventricle of the patient when the inlet opening of the brain ventricle catheter is placed in the brain ventricle of the patient; and
the tubular outlet element is shaped and sized to fluidly connect the shunt body with the lumen of the sinus system cavity of the patient when the outlet end and the distancer are inserted into the lumen of the sinus system cavity of the patient and the inlet opening of the brain ventricle catheter is placed in the brain ventricle of the patient.
27 . The shunt device according to claim 26 , wherein the distancer is configured to prevent the outlet end of the tubular outlet element from contacting surrounding endothelial tissue when the tubular outlet element is inserted into the sinus system cavity.
28 . The shunt device according to claim 26 , wherein the brain ventricle catheter is adapted for draining cerebrospinal fluid (CSF) from the brain ventricle of the patient 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.
29 . The shunt device according to claim 28 , wherein the sinus system cavity is sinus transversus or vena jugularis.
30 . The shunt device according to claim 26 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening.
31 . The shunt device according to claim 26 , wherein a tube inserted into the outlet opening of the tubular 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.
32 . The shunt device according to claim 26 , wherein the shunt body comprises a flow restricting part.
33 . The shunt device according to claim 26 , 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.
34 . 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, the tubular outlet element defining a central longitudinal axis;
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 the central longitudinal axis 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 opening along the central longitudinal axis of the tubular outlet element.
35 . The shunt device according to claim 34 , wherein the distancer is configured to prevent the outlet end of the tubular outlet element from contacting surrounding endothelial tissue when the tubular outlet element is inserted into a sinus system cavity.
36 . The shunt device according to claim 35 , wherein the outlet opening is maintained substantially at a central position of the sinus system cavity when the tubular outlet element is inserted into the sinus system cavity.
37 . The shunt device according to claim 34 , 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.
38 . The shunt device according to claim 37 , wherein the sinus system cavity is sinus transversus or vena jugularis.
39 . The shunt device according to claim 34 , wherein a flow restricting part is positioned between the inlet opening and the outlet opening.
40 . The shunt device according to claim 34 , wherein a tube inserted into the outlet opening of the tubular outlet element provides resistance to the flow of CSF through the shunt device, wherein the shunt body does not have a flow restricting part.
41 . The shunt device according to claim 34 , wherein the shunt body comprises a flow restricting part.
42 . The shunt device according to claim 34 , 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.
43 . The shunt device of claim 34 , wherein the distancer includes an expandable mesh.
44 . The shunt device of claim 43 , wherein the expandable mesh includes a first set of six mutually interconnected loops forming a ring of the loops that encircles the central longitudinal axis of the tubular outlet element.
45 . The shunt device of claim 44 , wherein the mesh includes a second set of three loops each connected to the attachment member.
46 . The shunt device of claim 44 ,
wherein the loops are interconnected at connections; and
wherein the distancer is configured such that when the distancer is in the at least one expanded state, the connections are portions of the distancer that are furthest from the central longitudinal axis of the tubular outlet element.
47 . The shunt device of claim 44 , wherein the loops are positioned circumferentially equidistantly around the central longitudinal axis of the tubular outlet element.
48 . The shunt device of claim 44 , wherein, when the tubular outlet element is inserted into a sinus system cavity and the distancer is in the at least one expanded state, the distancer is configured not to span a width of a lumen of the sinus system cavity such that some but not all of the loops contact an inner surface of a wall of the sinus system cavity.
49 . The shunt device of claim 44 , wherein the distancer is configured to span a width of a lumen of a sinus system cavity when the tubular outlet element is inserted into the sinus system cavity and the distancer is in the at least one expanded state.
50 . The shunt device of claim 34 , wherein the distancer is configured to span a width of a lumen of a sinus system cavity when the tubular outlet element is inserted into the sinus system cavity and the distancer is in the at least one expanded state.
51 . The shunt device of claim 34 , wherein the attachment member includes a ring fully surrounding the tubular outlet element.
52 . The shunt device of claim 34 , wherein the attachment member is positioned closer to the tubular inlet element than the outlet end of the outlet opening.
53 . The shunt device of claim 34 , wherein a portion of the distancer extends into the inner lumen of the tubular outlet element to restrict fluid flow through the inner lumen of the tubular outlet element.
54 . The shunt device of claim 53 , wherein the portion of the distancer that extends into the inner lumen of the tubular outlet element is a tube.
55 . A shunt device, comprising:
a tubular outlet element comprising an outlet end with an outlet opening, and an inner lumen extending through the tubular outlet element, the tubular outlet element defining a central longitudinal axis; 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 the central longitudinal axis of the tubular outlet element,
wherein the distancer is compactable into a compacted state, and expandable into at least one expanded state; and
wherein a portion of the distancer extends into the inner lumen of the tubular outlet element to restrict fluid flow through the inner lumen of the tubular outlet element.
56 . The shunt device of claim 55 , wherein the portion of the distancer that extends into the inner lumen of the tubular outlet element is a tube.
57 . The shunt device of claim 55 , wherein the distancer is configured to prevent the outlet end of the tubular outlet element from contacting surrounding endothelial tissue when the tubular outlet element is inserted into a sinus system cavity and the distancer is in the at least one expanded state.
58 . The shunt device of claim 1 , further comprising an attachment member positioned on an exterior of the tubular outlet element,
wherein the distancer includes exactly three branches extending from the attachment member.
59 . The shunt device of claim 26 , further comprising an attachment member positioned on an exterior of the tubular outlet element,
wherein the distancer includes exactly three branches extending from the attachment member.
60 . The shunt device of claim 34 , further comprising an introducer sheet,
wherein an entirety of the distancer is positioned within the introducer sheet when the distancer is in the compacted state.
61 . The shunt device of claim 34 , wherein an entirety of the attachment member is spaced apart along the central longitudinal axis from the outlet end.
62 . The shunt device of claim 1 ,
wherein the shunt body comprises an antechamber formed by the walls; and
wherein the walls end in a tapering end comprising a tip.
63 . The shunt device of claim 1 ,
wherein the shunt body comprises an antechamber formed by the walls; and
wherein the walls are opposite walls and include flat and/or dome walls.
64 . The shunt device of claim 1 ,
wherein the shunt body comprises an antechamber formed by the walls; and
wherein the walls are made from a soft material.
65 . The shunt device of claim 1 , wherein the shunt body comprises an antechamber.
66 . The shunt device of claim 1 , wherein the chamber is an antechamber.
67 . The shunt device of claim 1 , wherein the shunt body comprises a plurality of materials having different hardnesses.
68 . The shunt device of claim 1 , wherein the shunt body comprises self-healing silicone rubber.
69 . The shunt device of claim 1 , wherein the shunt body comprises a tapering end at which the brain ventricle catheter is connected.
70 . A method of shunting cerebrospinal fluid, comprising:
providing the shunt device of claim 1 ;
inserting the inlet end into the brain ventricle of the patient;
placing the shunt body subcutaneously on the calvarium of the patient; and
placing the outlet end in the sinus system cavity of the patient.