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.

Claims

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.

Description

SHORT DESCRIPTION OF THE DRAWINGS

[0101] In the following, exemplary embodiments of the device, the method, and the use according to the invention will be described with reference to the schematic drawings in which:

[0102] FIG. 1 shows a schematic picture of a shunt device installed in a patient;

[0103] FIG. 2 shows a part of the shunt device of FIG. 1;

[0104] FIG. 3 shows an outlet end of the shunt device of FIG. 2 comprising a distancer in an embodiment of the invention;

[0105] FIG. 4 shows the outlet end of FIG. 3 in a vessel;

[0106] FIG. 5 shows the outlet end of FIG. 3 in an introducer sheet;

[0107] FIG. 6 is a side view of the outlet end with two sets of distancer members in another embodiment of the invention;

[0108] FIG. 7 is a view in direction of arrow VII in FIG. 6; and

[0109] FIG. 8 is a view of the outlet end with a distancer in a third embodiment.

DETAILED DESCRIPTION OF THE DRAWINGS

[0110] FIG. 1 shows a shunt device according to an embodiment of the present invention installed in a patient.

[0111] The shunt device (1) comprises a shunt body (3) which is positioned subcutaneously on top of the calvarium (5) of the patient.

[0112] A tubular inlet element (7), constituting a brain ventricle catheter, is connected to a first end of the shunt body (3). The tubular inlet element (7) comprising an inlet end (9) with an inlet opening (11), which is inserted into a CSF containing space (13) from which it is desired to drain CSF, such as the subarachnoid space or a brain ventricle.

[0113] A tubular outlet element (15) is connected to another, opposite end of the shunt body (3. The tubular outlet element (15) comprises an outlet end (17) with an outlet opening (19) (see FIG. 3). The outlet end (17) is inserted in a cavity of the sinus system (21) of the patient, e.g. in sinus transversus or in vena jugularis, the outlet element thus constituting a sinus catheter.

[0114] FIG. 2 shows a preferred embodiment of the shunt body (3), preferably made from silicone rubber, comprising an antechamber (23) having opposite flat walls (25), preferably made from hard silicone rubber, and opposite domed walls (27), preferably made from soft, perforatable, self-healing silicone rubber. Preferably, at the first end which is an inlet end of the shunt body (3), the antechamber's walls end in a tapering end comprising a tip (29), to which the brain ventricle catheter or tubular inlet element (7) can be connected and secured.

[0115] The shunt body further comprises a flow restricting member (31) provided by a tubular flow restricting part of the shunt body (3). Preferably, the antechamber (23) is connected to the tubular flow restricting part so that an outlet end of the antechamber (23) forms an inlet to the tubular flow restricting part, i.e. the flow restricting member (31).

[0116] Preferably, a check valve or non-return valve, i.e. a one-way valve (33) is arranged both at the entrance to the antechamber (23) and at an outlet of the flow restricting member (31). Preferably, said one-way valves do not have any inherent resistance or opening pressure, and essentially do not exert any resistance on the flow of cerebrospinal fluid from the brain ventricle catheter through the shunt body (3) to the sinus catheter i.e. the outlet element (15).

[0117] In preferred embodiments of the present invention, fluidic connection to a sinus system cavity of the patient is provided by the tubular outlet element (15), which is attached to the shunt body (3) at the end thereof opposite the tip (29), and fluidic connection to a brain ventricle of the patient is provided by the tubular inlet member (7) or brain ventricle catheter which is preferably attached to the tip (29), which is provided with an annular bead, and the tubular inlet member is optionally secured by means of a ligature.

[0118] Preferably, the length of the tip (29) is about 5 mm. In one preferred embodiment of the present invention, the tubular flow restricting member (31) is dimensioned in accordance with Hagen-Poiseulle's law so as to provide a passive and substantially constant resistance to flow of less than 8 mm Hg/ml/min.

[0119] In preferred embodiments an internal radius, R, of an inner lumen of the tubular flow restricting part constituting the flow restricting member (31) is more than 0.05 mm and preferably less than 0.50 mm, and appropriate lengths, L, of the flow restricting member (31) can be calculated accordingly, as follows:

L=((ICP−P.sub.ss)×π×R.sup.4)/(8×F×V)   (Hagen-Poiseuille's law),

[0120] wherein ICP is the intracranial pressure, P.sub.ss is the pressure in the sagittal sinus, F is the flow rate of the cerebrospinal fluid and V is the viscosity of the cerebrospinal fluid. In preferred embodiments, the length of the flow restricting part is in the range of from about 3.0 mm to about 90 mm.

[0121] The shunt device described so far of the present invention is embodied and used e.g. as disclosed in US 2007/0112291 A1, which is incorporated herein by reference.

[0122] Referring to FIGS. 3 and 4, according to the present invention the outlet end (17) of the tubular outlet element (15) of FIG. 2 is provided with a distancer (35) for keeping the outlet end (17) with the outlet opening (19) a minimum distance from the inner surface of a wall (37) of a vessel or cavity of the sinus system in which the outlet end is positioned and thus to keep the outlet end (17) at a minimum distance from the endothelium of said wall (37).

[0123] In the embodiment shown in FIGS. 3 and 4 the distancer (35) comprises a distance member (39) formed as a resilient mesh comprising a first set of six loops (41) mutually interconnected at connections (43) to respective adjacent loops thus forming a ring of loops encircling a central longitudinal axis (45) extending through and out from the tubular outlet element (15).

[0124] Of the six loops (41), only three are seen in FIG. 3 the other three being hidden behind the three loops being actually seen. The resilient mesh further comprises a second set of three loops (47) each of which is connected through a branch (49) with an attachment member (51) by which the distancer (35) is connected to the tubular outlet element (15).

[0125] In an expanded use state of the distance member (39), the connections (43) are positioned furthest from the central longitudinal axis (45) extending though and out from the tubular outlet element (15) and the connections (43) constitutes distance keepers (43a) of the distancer (35).

[0126] Thus in the present embodiment shown in FIGS. 3 and 4, six distance keepers are provided and they are placed circumferentially in a substantially equidistant manner around the central longitudinal axis (45).

[0127] As it is best seen in FIG. 4 the distancer (35) will keep the outlet end (17) with the outlet opening (19) at a minimum distance from the inner surface of the wall (37). In the embodiment shown the distancer (35) does not span the width of the cavity or vessel in which it is positioned and accordingly only a few, if any, of the distance keepers or connections (43) are actually in contact with the inner surface of the wall (37). It is however possible within the present invention that the distancer (35) does span said width.

[0128] For insertion of the tubular outlet element (15) in a cavity or vessel of a patient the distancer (35) is, as shown in FIG. 5 compacted and introduced together with the outlet end (17) of the tubular outlet element (15) into an introducer sheet (53). Such procedure will in general be familiar to the skilled person.

[0129] Thus in a method for shunting cerebrospinal fluid using the shunt device (1) steps to be performed are [0130] a) inserting at least a part of the inlet end (9) of the tubular inlet element (7), comprising the inlet opening (11), into a CSF containing space, such as the subarachnoid space of a patient, [0131] b) inserting at least a part of the outlet end (17) of the tubular outlet element (15), comprising the outlet opening (19) and the distancer (35), said part of the outlet end (17) and the distancer (35) being accommodated in an introducer sheet (53) for the distancer to be in a compacted state, into a cavity (21) of the sinus system such as the sinus transversus or the vena jugularis cavity of the patient, [0132] c) changing the state of the distancer from the compacted state to an expanded use state by withdrawing the introducer sheet (53), and [0133] d) fixating the shunt device (1).

[0134] The insertion of the shunt device may be carried out through any suitable entrance point, known to the person skilled in the art.

[0135] Such methods are to be considered as anticipated by the present invention.

[0136] In an embodiment the insertion of at least a part of the outlet end (17) of the tubular outlet element (15) and the distancer (35) in the introducer sheet (53), is carried out through an opening in the vena jugularis.

[0137] In an embodiment, the shunt device is fixated in a position where the distancer (35) is at a distance of at least 3 cm along the central longitudinal axis (45) from the opening forming the entry point into the vena jugularis. If another entry point is used, the shunt device is preferably fixated in a position, so that the distancer is at least 3 cm away from the entry point to the cavity (21) into which the distancer (35) is inserted. By fixating the shunt device (1) in a position where the distancer (35) is at a distance of at least 3 cm from the entry point into the cavity (21) wherein the distancer (35) is inserted, the risk of endothelium growing over the outlet end (17) and the outlet opening (19) of the tubular outlet element (15) is minimal.

[0138] The shunt device (1) having been installed may be used to relieve hydrocephalus and drain CSF and possible toxic substances in the CSF that for some reason is not drained naturally. Thus the shunt device may apart from treating hydrocephalus, be used for treating clinical conditions such as e.g. Alzheimer's disease. Treatment of Alzheimer's disease is an example of a clinical condition capable of being treated by using the shunts of the invention to drain CSF comprising e.g. amyloid plaque proteins from the CSF space of a patient.

[0139] In addition to Alzheimer's disease, the shunt device according to the present invention will also be useful in treating other conditions resulting from the accumulation of toxic substances and resulting lesions in the patient's brain, such as e.g. Down's Syndrome, hereditary cerebral hemorrhage with amyloidosis of the Dutch Type (HCHWA-D), epilepsy, narcolepsy, Parkinson's disease, polyneuropathies, multiple sclerosis, amyotrophic lateral sclerosis (ALS), myasthenia gravis, muscular dystrophy, dystrophy myotonic, other myotonic syndromes, polymyositis, dermatomyositis, brain tumors, Guillain-Barre-Syndrome, and the like, as disclosed in US 2007/0112291 A1 and US 2007/0112293 A1, both of which are incorporated herein by reference.

[0140] As further disclosed in US 2007/0112291 A1, the methods disclosed herein are also envisaged as being used in combination with other medical treatments, for instance conventional drug treatments.

[0141] By “in combination”, it is meant that the methods disclosed herein may be used on an individual prior to, during, or after treatment of the individual with one or more other medical treatment.

[0142] Said medical treatment may comprise administration of a compound inside the inner lumen of said shunt device. In one preferred embodiment, an individual is treated with the methods disclosed herein, in combination with administration of one or more of an antibiotic, anti-coagulants such as heparin, Acetazolamide or Frusemide, Isosorbide, Glycerol, Urokinase, calcification inhibiting agents or MEDTA. In another, equally preferred embodiment, a patient is treated with the methods disclosed herein, in combination with administration of one or more of an anti-infective compound such as e.g. vancomycin, EDTA, Gentamycin, Chymotrypsin, chlorine dioxide, or Minocycline. It is also envisaged that the shunt system of the present invention may be adapted to be capable of being infused with a drug, thus allowing ease of drug delivery. The shunt device may also be impregnated with bioactive compounds, such as a drug, before being positioned inside the patient.

[0143] FIGS. 6 and 7 show a second embodiment of a distancer (135) according to the present invention comprising two sets (155a) and (155b) of distance members (139a) and (139b) wherein the distance members (139a) of the first set (155a) are attached to a first attachment member (151a) and the distance members (139b) of the second set (155b) are attached to a second attachment member (151b). The attachment members (151a and (151b) are mounted of the outlet end (17) of the tubular outlet element (15) at the outlet opening (19). Each set (155a) and (155b) comprise three distance members (139a) and (139b), respectively and apart from mounting the respective sets (155a) and (155b) the attachment members (151a) and (151b) constitute connector members connecting and retaining the mutual positions of the respective distance members (139a) and (139b). Alternatively the distance members might each be mounted on the tubular outlet element by means of respective attachment members (not shown).

[0144] In the latter case independent connector members might be provided for retaining the mutual positions of the distance members. As seen in FIG. 7 the distance members (139a) (and the distance members (139b) which are hidden behind the former) are positioned with mutual angular distances α, β and γ each of angles α, β and γ being 120°.

[0145] The distance members (139a) and (139b) are each shaped to have a curved part (57) defining the maximum protrusion of the respective distance member (139a) and (139b) the curved parts (57) thus constituting the distance keepers (59) of the respective distance members (139a) and (139b).

[0146] The two sets (155a) and (155b) of distance members are positioned at different distances from the outlet opening (19) along the central longitudinal axis (45). Accordingly, the distancer (135) has a certain length in the direction of the central longitudinal axis (45) and the distancer (135) has accordingly the effect of keeping the outlet end (17) substantial parallel to the wall of the vessel or cavity in which the outlet end (17) is installed apart from maintaining the outlet end (17) with the outlet opening (19) at a minimum distance from the wall of said vessel or cavity and the endothelium thereof.

[0147] FIG. 8 shows in perspective a third embodiment of a distancer (235) according to the present invention. In this embodiment the distance members (239) are cut and formed from a tube (261) of a shape-memory alloy. The figure shows the distance member (239) in its use position which it will obtain when installed in a patient. A part of the tube (261) is inserted into the outlet opening (19) of the tubular outlet element (15) for the mounting of the distancer (235). The distancer (235) comprises two sets (255a) and (255b) of each three distance members (239a) and (239b). Like in the second embodiment the distance members (239a) and (239b) are curved, but in this embodiment the ends of the respective distance members protrude most from the central longitudinal axis (45) of the tubular outlet element (15) and accordingly these ends constitute distance keepers (259).

[0148] Like in the second embodiment the two sets (255a) and (255b) of distance members (239a) and (239b) are positioned at different distance from the outlet opening of the tubular outlet element and accordingly the outlet end thereof is kept substantially parallel to the wall of the vessel or cavity in which the outlet end with the distancer (235) is installed apart from the outlet end (17) with the outlet opening (19) being kept at a minimum distance from the wall of said vessel or cavity and the endothelium thereof.

[0149] It should be noted that correspondingly in the first embodiment the distancer (35) might be provided with two (or more) sets of distance members (39) in the form of resilient meshes attached to the outlet end (17) by means of respective attachment members (51) at different distances from the outlet opening (19) thereby obtaining for the first embodiment the effect of the outlet end (17) being kept substantially parallel to the wall of the vessel or cavity in which the outlet end (17) with such embodiment of the distancer is installed.

[0150] It should also be noted that although in the embodiment of the shunt devise described above the shunt body (3) comprises a flow restricting member (31), the flow restricting effect thereof might be obtained by a flow restricting part positioned elsewhere in the shunt device (1) between the inlet opening (11) and the outlet opening (19), e.g. in the third embodiment the tube (261) might provide or accommodate a flow restricting member providing the pursued resistance to the flow of the CSF through the shunt device in which case the flow restricting member of the shunt body might be eliminated.

[0151] Embodiments of the present invention are recited in the below-captioned items. [0152] 1. A shunt device comprising a tubular inlet element (7) having an inlet end (9) with an inlet opening (11) for insertion in a cerebrospinal fluid (CSF) containing space (13), such as a subarachnoid space or a brain ventricle, and a tubular outlet element (15) having an outlet end (17) with an outlet opening (19) adapted for insertion in a sinus system cavity (21), such as sinus transversus or vena jugularis, said tubular elements (7, 15) respectively comprising an inner lumen extending through the respective tubular element (7, 15), and said shunt device further comprising a flow restricting part (31) positioned between the inlet opening (9) and the outlet opening (19), the inner lumen of the tubular inlet element (7) and the inner lumen of the tubular outlet element (15) being connected for CSF to flow through the shunt device from the inlet opening (7) to the outlet opening (19), and the shunt device further comprises a one-way valve (33) preventing flow in a direction from the outlet opening to the inlet opening, characterized in that it further comprises a distancer (35; 135; 235), said distancer being provided at the outlet end (17) of the tubular outlet element (15) and comprising at least three distance keepers (43a; 59; 259) each being positioned at a distance from the tubular outlet element (15) in a direction perpendicular to a central longitudinal axis (45) of the tubular outlet element (15) at least in a use state of the shunt device. [0153] 2. A shunt device according to item 1, 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. [0154] 3. A shunt device according to item 1 or 2, wherein said at least three distance keepers are positioned equidistantly from each other at least when in a use state. [0155] 4. A shunt device according to one or more of the preceding items wherein said at least three distance keepers and/or distance members are positioned in a fashion satisfying the equation a+β+γ=360°, where α, β, and γ represents non-overlapping angles between two distance keepers and/or distance members when seen in the direction of the central longitudinal axis of the inner lumen, and where α>90°, β>90°, and γ>90°, and preferably α<150°, β<150°, and γ<150°. [0156] 5. A shunt device according to one or more of items 2-4, 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. [0157] 6. A shunt device according to one or more of items 2-5, wherein the distancer comprises two or more sets of distance members and wherein the distance members of one set being arranged to protrude from the tubular outlet element at a different distances from the outlet opening in the direction of the central longitudinal axis than the distance members of another set. [0158] 7. A shunt device according to one or more of the preceding items, wherein the distancer comprises a resilient mesh comprising the at least three distance keepers defining the maximum protrusion of the mesh from the central longitudinal axis. [0159] 8. A shunt device according to one or more of the preceding items, wherein the distancer is connected to the tubular outlet element via one or more attachment members. [0160] 9. A shunt device according to one or more of the preceding items, wherein the distancer is compactable into a compacted state and expandable into at least one expanded use state where the at least three distance keepers protrude further from the central longitudinal axis than in the compacted state. [0161] 10. A shunt device according to any one of the preceding items, wherein the flow restricting part is a part of a shunt body and wherein the tubular inlet element further includes a brain ventricle catheter adapted for draining cerebrospinal fluid from a brain ventricle to the shunt body and the tubular outlet element includes a sinus catheter adapted for draining cerebrospinal fluid from the shunt body to the sinus system cavity. [0162] 11. Method for shunting cerebrospinal fluid using a shunt device according to one or more of the preceding items, the method comprising the steps of: [0163] a) inserting at least a part of the tubular inlet element, comprising the inlet opening, into a cerebrospinal fluid containing space, such as the subarachnoid space of a patient, [0164] b) inserting at least a part of the tubular outlet element, comprising the outlet opening and the distancer in a compacted state into a cavity of the sinus system, such as the sinus transversus or the vena jugularis cavity of the patient, [0165] c) changing the state of the distancer from the compacted state to an expanded use state, and [0166] d) fixating the shunt device. [0167] 12. Method of item 10, wherein the insertion of the tubular outlet element end in step b) is carried out through an opening in the vena jugularis. [0168] 13. Method of item 11 wherein the shunt device is fixated in a position where the distancer is at a distance of at least 3 cm, from the opening in the vena jugularis. [0169] 14. Use of a shunt device according to any one of items 1 to 10 in the treatment of hydrocephalus.