SHUNT SYSTEM, SHUNT AND METHOD FOR TREATING AN OCULAR DISORDER

Abstract

A shunt 10 for implantation in the human body for treating ocular disorders related to disorders of intraocular or intracranial pressure by providing for flow of aqueous fluid in the anterior chamber A of the eye and cerebrospinal fluid in the subarachnoid space B surrounding the optic nerve C. The shunt has a proximal end 12 which is implanted in the ocular anterior chamber and a distal end 14 which is implanted in the subarachnoid space. The shunt has a two-part construction, including a flexible distal tube 18 and a rigid proximal tube 20. The distal tube has a distal stop formation 26 near the distal end 14 which is located in the subarachnoid space upon implantation of the distal end, resisting withdrawal of the shunt. The proximal tube has a curved portion which conforms to the anatomical curvature of the ocular globe.

Claims

1-48. (canceled)

49. A shunt for treating an ocular disorder of intraocular or intracranial pressure by regulating intraocular pressure in an eye of a patient, the shunt comprising: a proximal shunt portion defining a proximal end which is implantable in an ocular anterior chamber of the patient and a distal shunt portion defining a distal end which is implantable in a subarachnoid space of the patient, the shunt defining a lumen extending longitudinally between the distal and proximal ends, the shunt having an enlarged distal stop formation near the distal end of the shunt, configured to be disposed in the subarachnoid space after implantation of a distal end region of the shunt in the subarachnoid space, for resisting withdrawal of the shunt after implantation in the subarachnoid space, and the shunt being flexible along a portion of a length of the shunt configured to conform to an outer anatomical curvature of an ocular globe, the proximal shunt portion including at least one outwardly projecting ridge formation for resisting migration of the proximal shunt portion after implantation thereof in the ocular anterior chamber, the distal shunt portion and the proximal shunt portion being releasably connected to one another in a press fit configuration, at a connection point which is configured to be along an outer surface of the ocular globe, with the lumen of the shunt extending continuously through the distal and proximal shunt portions.

50. The shunt of claim 49, further comprising: an enlarged proximal stop formation disposed along the length proximal to the distal end of the shunt between the proximal end and the enlarged distal stop formation to be disposed externally of an optic nerve sheath to prevent over-migration of the shunt into the subarachnoid space.

51. The shunt of claim 49, wherein the distal shunt portion comprises a rigid implant body defining the distal end of the shunt, the proximal shunt portion facilitating advancement of the proximal shunt portion along a scleral passageway defined in a sclera extending to the ocular anterior chamber.

52. The shunt of claim 49, wherein the distal end of the shunt is tapered towards the distal end of the shunt to facilitate advancement of the distal end region of the shunt along an anatomical passageway of the eye.

53. The shunt of claim 49, wherein the proximal shunt portion is tapered towards the proximal end of the shunt to facilitate displacement of the proximal shunt portion along a scleral passageway of the eye.

54. The shunt of claim 49, wherein the proximal shunt portion comprises a wall defining two or more slots permitting drainage of aqueous fluid into the lumen of the shunt from different directions.

55. The shunt of claim 49, wherein the proximal shunt portion comprises a straight section at the proximal end of the shunt and a curved section spaced from the proximal end of the shunt, the curved section having a curvature to confirm to a portion of the outer anatomical curvature of the ocular globe.

56. The shunt of claim 49, wherein the proximal shunt portion comprises an outwardly-projecting locating formation for engagement by a suture for suturing the proximal shunt portion to a sclera to hold the proximal shunt portion in place.

57. The shunt of claim 49, wherein a distal end of the shunt is closed, wherein the distal shunt portion comprises a side wall defines one or more fluid flow openings non-parallel to the lumen and in fluid communication therewith.

58. A shunt for treating an ocular disorder in an eye of a patient, the shunt comprising: a proximal shunt portion defining a proximal end to be received in an ocular anterior chamber of the patient, the proximal shunt portion comprising at least one outwardly projecting ridge formation for resisting migration of the proximal shunt portion in the ocular anterior chamber; a distal shunt portion releasably connected to the proximal shunt portion in a press-fit configuration at a connection point to be disposed along an outer surface of an ocular globe, the distal shunt portion defining a distal end to be received in a subarachnoid space of the patient; an enlarged distal stop formation disposed proximal to the distal end to be disposed in the subarachnoid space for resisting withdrawal of the shunt after implantation in the subarachnoid space, wherein the shunt defines a length and a lumen extending continuously between the distal and proximal ends, and wherein the shunt is flexible along a portion of the length of the shunt to conform to an outer anatomical curvature of the ocular globe.

59. The shunt of claim 49, further comprising: an enlarged proximal stop formation disposed along the length proximal to the distal end of the shunt between the proximal end and the enlarged distal stop formation to be disposed externally of an optic nerve sheath to prevent over-migration of the shunt into the subarachnoid space.

60. The shunt of claim 49, wherein the distal shunt portion comprises a rigid implant body defining the distal end of the shunt, the proximal shunt portion facilitating advancement of the proximal shunt portion along a scleral passageway defined in a sclera extending to the ocular anterior chamber.

61. The shunt of claim 49, wherein the distal end of the shunt is tapered towards the distal end of the shunt to facilitate advancement of the distal end of the shunt along an anatomical passageway of the eye.

62. The shunt of claim 49, wherein the proximal shunt portion is tapered towards the proximal end of the shunt to facilitate displacement of the proximal shunt portion along a scleral passageway of the eye.

63. The shunt of claim 49, wherein the proximal shunt portion comprises a wall defining two or more slots permitting drainage of aqueous fluid into the lumen of the shunt from different directions.

64. The shunt of claim 49, wherein the proximal shunt portion comprises a straight section at the proximal end of the shunt and a curved section spaced from the proximal end of the shunt, the curved section having a curvature to confirm to a portion of the outer anatomical curvature of the ocular globe.

65. The shunt of claim 49, wherein the proximal shunt portion comprises an outwardly-projecting locating formation for engagement by a suture for suturing the proximal shunt portion to a sclera to hold the proximal shunt portion in place.

66. The shunt of claim 49, wherein a distal end of the shunt is closed, wherein the distal shunt portion comprises a side wall defines one or more fluid flow openings non-parallel to the lumen and in fluid communication therewith.

67. A shunt for treating an ocular disorder in an eye of a patient, the shunt comprising: a proximal shunt portion defining a proximal end to be received in an ocular anterior chamber of the patient; and a distal shunt portion releasably connected to the proximal shunt portion in a press-fit configuration at a connection point to be disposed along an outer surface of an ocular globe, the distal shunt portion defining a distal end to be received in a subarachnoid space of the patient; wherein the shunt defines a length and a lumen extending continuously between the distal and proximal ends, and wherein the shunt is flexible along a portion of the length of the shunt to conform to an outer anatomical curvature of an ocular globe.

68. The shunt of claim 67, wherein the shunt incorporates an elutable therapeutic substance comprising an antibiotic, an anticlotting agent, or an anti-vascular endothelial growth factor.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0071] Further features of the invention are described hereinafter by way of a non-limiting example of the invention with reference to and as illustrated in the accompanying diagrammatic drawings. In the drawings:

[0072] FIG. 1 shows a cross-sectional view of a human eye;

[0073] FIG. 2 shows a cross-sectional view of a human eye in which a first embodiment of a shunt in accordance with the invention, has been implanted to provide for fluid flow between the anterior chamber of a human eye and the subarachnoid space surrounding the optic nerve;

[0074] FIG. 2A shows a side view of the shunt of FIG. 2;

[0075] FIG. 3A shows a three-dimensional view of a shunt inserting device of a shunt system in accordance with the invention;

[0076] FIG. 3B shows a three-dimensional view of the shunt inserting device of FIG. 3A with the housing removed to show internal components thereof;

[0077] FIG. 4 shows a side view of the shunt inserting device of FIG. 3B;

[0078] FIG. 5 shows enlarged detail A of the shunt inserting device of FIG. 4;

[0079] FIG. 6 shows a top view of the distal insertion tube of the shunt inserting device of FIG. 4;

[0080] FIG. 7 shows a sectional side view of the distal insertion tube of FIG. 6;

[0081] FIGS. 8A-8C show various views of the tissue-penetrating tip of the distal inserting tube of the shunt inserting device of FIG. 4, illustrating the manner in which the tissue penetrating tip is formed;

[0082] FIG. 9 shows a side view of the distal tube of the shunt of FIG. 2A;

[0083] FIG. 10 shows a sectional side view of the distal tube of the shunt of FIG. 2A, sectioned along section line X-X of FIG. 9;

[0084] FIG. 11 shows another side view of the distal tube of the shunt of FIG. 2A;

[0085] FIG. 12 shows a sectional side view of the distal tube of the shunt of FIG. 2A, sectioned along section line XII-XII of FIG. 11;

[0086] FIG. 13 shows a side view of the proximal tube of the shunt of FIG. 2A;

[0087] FIG. 14 shows another side of the proximal tube of the shunt of FIG. 2A;

[0088] FIG. 14A shows enlarged detail C of the proximal tube of FIG. 14;

[0089] FIG. 15 shows a sectional side view of the proximal tube of the shunt of FIG. 2A, sectioned along section line XV-XV of FIG. 14;

[0090] FIG. 15A shows a side view of another embodiment of the proximal tube of the shunt in accordance with the invention;

[0091] FIGS. 16A-16C show the shunt inserting device in a first mode of operation;

[0092] FIGS. 17A-17C show the shunt inserting device in a second mode of operation;

[0093] FIGS. 18A-18C show the shunt inserting device in a third mode of operation;

[0094] FIGS. 19A-19E show, in sequence, the manner in which the distal end of the shunt is implanted in the subarachnoid space surrounding the optic nerve;

[0095] FIGS. 20A-20C show, in sequence, the manner in which the proximal end of the shunt is implanted in the anterior chamber of the eye;

[0096] FIG. 21 shows a side view of a second embodiment of a shunt in accordance with the invention;

[0097] FIG. 22 shows an exploded three-dimensional view of a distal tube of the shunt of FIG. 21 and a shunt inserting device for implanting the distal tube in the subarachnoid space;

[0098] FIG. 23 shows an exploded sectional side view of the distal tube and shunt inserting device of FIG. 22;

[0099] FIG. 24 shows a side view of the distal tube of FIG. 22;

[0100] FIG. 25 shows a sectional side view of the distal tube of FIG. 22, sectioned along section line XXV-XXV of FIG. 24;

[0101] FIG. 26 shows another side view of the distal tube of FIG. 22;

[0102] FIG. 27 shows a sectional side view of the distal tube of FIG. 22, sectioned along section line XXVII-XXII of FIG. 26; and

[0103] FIGS. 28A-28E show, in sequence, the manner in which the distal end of the second embodiment of the shunt is implanted in the subarachnoid space surrounding the optic nerve.

DETAILED DESCRIPTION OF THE INVENTION

[0104] With reference to FIG. 1 of the drawings, a cross-sectional view illustrating anatomical parts of a human eye 2 which are required for use in the description which follows below, comprises: [0105] A: Anterior chamber filled with aqueous fluid [0106] B: Subarachnoid space filled with cerebrospinal fluid [0107] C: Optic nerve [0108] D: Optic nerve sheath [0109] E: Sclera [0110] F: Subtenon's space [0111] G: Tenon's capsule [0112] H: Conjunctiva [0113] I: Eyelids [0114] J: Limbus and trabecular meshwork [0115] K: Posterior segment filled with vitreous jelly [0116] L: Cornea [0117] M: Ciliary body [0118] N: Ocular globe

[0119] With reference to FIGS. 1 to 20 of the drawings, a shunt in accordance with the invention, is designated generally by the reference numeral 10. The shunt 10 is adapted for implantation in the human body so as to provide for flow communication between aqueous fluid in the anterior chamber A of the eye and cerebrospinal fluid in the subarachnoid space B surrounding the optic nerve C. The shunt is adapted for treating ocular disorders related to disorders of intraocular or intracranial pressure in a patient. The shunt 10 when implanted, regulates intraocular pressure in the eye of a human patient. For the treatment of glaucoma, the shunt permits aqueous fluid to drain from the anterior chamber of the eye into the subarachnoid space, thereby reducing intraocular pressure. For the treatment of phthisis and idiopathic intracranial hypertension, the shunt permits the flow of cerebrospinal fluid which has a similar composition to aqueous fluid, to flow to the anterior chamber of the eye thereby increasing intraocular pressure.

[0120] The shunt 10 has an elongate tubular configuration having a proximal end 12 and a distal end 14. The shunt defines a lumen 16 which extends between the distal and proximal ends.

[0121] The shunt 10 is of a two-part construction, including a distal shunt portion comprising a flexible distal tube 18 of silicone rubber; and a proximal shunt portion comprising a rigid plastics proximal tube 20 of polyetheretherketone (PEEK). The rigid proximal tube 20 is removably connected to the flexible distal tube 18. This allows the surgeon to assess the function of the shunt and flush the lumen or inject a therapeutic substance through the shunt as required peri- or post-operatively. The distal tube 18 defines the distal end 14, while the proximal tube 20 defines the proximal end 12. Opposite ends 22, 24 of the proximal tube 20 and the distal tube 18, respectively, are removably connected. More specifically, the end 22 of the proximal tube 20 is press-fitted into the end 24 of the distal tube 18 in an arrangement wherein internal passages of the distal and proximal tubes form a continuous internal passage defining the lumen 16.

[0122] The rigidity of the proximal shunt portion facilitates its displacement along a narrow scleral passage which prevents aqueous fluid leakage and prevents tube erosion through conjunctival tissue.

[0123] The distal tube 18 has an enlarged resiliently compressible distal stop formation 26 in the form of an annular flange near the distal end 14. The distal stop formation 26 is spaced a predetermined distance from the distal end 14. The distal end 14 of the distal tube 18 is closed, with two fluid flow openings 28.1, 28.2 being defined on opposite sides of the distal tube at locations between the distal stop formation 26 and the distal end 14.

[0124] The shunt further includes an enlarged proximal stop formation 30 in the form of an annular flange which is spaced from the distal stop formation a predetermined distance at a position relatively closer to the proximal end of the distal tube.

[0125] The distal stop formation 26 resists withdrawal of the shunt after implantation of the shunt in the subarachnoid space, while the proximal stop formation 30 is disposed externally of the optic nerve sheath upon implantation of the distal end of the shunt in the subarachnoid space for preventing over-migration of the shunt into the subarachnoid space.

[0126] The proximal end 12 of the shunt is convexly rounded so as to provide the proximal tube with a tapered end facilitating displacement of the proximal tube along the scleral passageway towards the anterior chamber. The proximal tube 20 has a curved section 32 near the end 22 and a straight section 34 extending between the curved section and the proximal end 12. The curvature of the curved section conforms to the anatomical curvature of the ocular globe N as is shown in FIG. 2, thereby preventing erosion of the surrounding tissue. The straight section 34 is displaced along the scleral passageway from about 4 mm away from the corneal limbus to enter the anterior chamber at the trabecular meshwork.

[0127] The distal tube is approximately 30 mm in length and has an outer diameter of 1 mm or less. The flexibility of the distal tube allows the distal tube to conform to the anatomical curvature of the ocular globe with minimal resistance. The distal tube may incorporate an elutable therapeutic substance comprising one or more of an antibiotic, an anticlotting agent and an anti-vascular endothelial growth factor.

[0128] The proximal tube is approximately 10 mm in length and has an outer diameter of 0.5 mm or less. The relatively small outer diameter of the proximal tube prevents endothelial decompensation and tube erosion. The proximal tube defines a fluid flow opening 36 at the proximal end 12. The opening 36 is defined by a central opening at the proximal end 12 and a pair of opposed slots 38 defined in opposite sides of a wall of the proximal tube at the proximal end 12. These allow fluid to drain into the proximal end opening from multiple axes and prevent tube blockage by iris tissue.

[0129] With reference to FIG. 15A, another embodiment of a proximal tube of the shunt is designated by the reference numeral 120. The proximal tube is similar to the proximal tube 20 and, as such, the same and/or similar reference numerals are used in FIG. 15A to designate features of the proximal tube which are the same and/or similar to features of the proximal tube 20. A first difference is that the proximal tube 120 includes three spaced annular ridges 102.1, 102.2 and 102.3 near the proximal end 122 of the proximal tube to resist migration of the proximal tube after implantation in the ocular anterior chamber. A second difference is that the proximal tube 120 includes a fenestrated flare 101 providing for suturing of the proximal tube 120 to the sclera to hold the proximal tube in place.

[0130] The invention extends to a shunt system including the shunt 10 and a shunt inserting device 40 for implanting the shunt in the subarachnoid space surrounding the optic nerve. The shunt inserting device 40 comprises a tubular housing 42, a shunt advancing device 44 and a distal inserting portion 46 mounted to the housing. The housing 42 provides a handle by which the shunt inserting device can be held.

[0131] The distal insertion portion 46 comprises a lancet 48 defining an internal passageway 50 within which the distal tube 18 of the shunt is slidably located. The lancet has a distal end 52 defining a discharge opening 54 through which the distal tube is advanced. The distal end 52 defines a tissue-penetrating tip 56 for penetrating the optic nerve sheath.

[0132] The distal end of the lancet is defined by a taper cut. With reference to FIGS. 8A-8C of the drawings, in order to form the taper cut, a first bevel cut 58 and a second bevel cut 60 is made at the distal end (see FIGS. 8A and 8B). The taper cut has a distal end coinciding with the tissue-penetrating tip 56 and a proximal end 62. The taper cut is defined by the first bevel cut 58 proximate the proximal end 62 and the second bevel cut 60 proximate the tissue-penetrating tip. The bevel cuts define sharp edges. After making the bevel cuts, the first bevel cut 58 and a portion of the second bevel cut 60 spaced from the tissue-penetrating tip, are blunted by rounding off sharp edges (see FIG. 8C) so as to prevent further cutting of tissue and promote maximal stretching, but not tearing, of tissue around the lancet as it is inserted into the optic nerve sheath in order to maximise a seal formed around the lancet by the optic nerve sheath, but also minimise inflammation. The tissue-penetrating tip and a portion of the second bevel cut adjacent the tissue-penetrating tip are not blunted and thus retain their sharp edged properties for cutting through the optic nerve sheath. The blunted regions of the first bevel cut and of a portion of the second bevel cut are designated by the reference letter B while the distal end region of the second bevel cut having sharp edges are designated by the reference letter S in FIG. 8C.

[0133] The lancet 48 has an enlarged stop formation 66 in the form of an annular flange at a location spaced a predetermined distance from the tissue-penetrating tip 56. The stop formation 66 is configured and dimensioned so as to abut against an external side of the optic nerve sheath thereby preventing over-insertion of the tissue-penetrating tip into the subarachnoid space.

[0134] The shunt advancing device 44 is configured for advancing the distal tube 18 of the shunt distally along the lancet 48 for inserting the distal end of the shunt into the subarachnoid space. The mechanism 44 includes an elongate advancing stylet 68.

[0135] The distal tube 18 is received within the internal passageway 50 of the lancet 48 and the stylet 68 is received within the lumen 16 of the distal tube. The mechanism 44 includes a piston 70 which is slidably displaceable along an internal passageway within the housing 42. The mechanism includes a slider block 72 at a distal end of the housing which is slidably supported within the housing and a mounting block 76 at the distal end which is fixedly mounted to the housing. The lancet 48 is fixedly mounted to the mounting block 76. A proximal end of the stylet is connected to the piston, while the slider block defines a passage within which the stylet is slidably located. A sleeve 95 is located within the mounting block for supporting the distal tube at its end 24.

[0136] The mechanism also include a coil spring 78 which is mounted at opposite ends thereof to spigot mounting formations 80, 82 of the slider block 72 and the piston 70, respectively. The coil spring is compressed when the piston is displaced towards the slider block resulting in the spring exerting a force on the piston 70 for urging the piston away from the slider block.

[0137] The piston has a resiliently deformable lever arm 82 having an engagement projection 84 at an end thereof, while the slider block 72 has a slider arm 86 defining a complementary engagement aperture 86 within which the projection 84 of the piston is receivable for releasably locking the piston to the slider block.

[0138] The housing 42 defines an aperture 90 at a proximal end region thereof within which the engagement projection of the piston 70 is received for releasably locking the piston to the housing in a retracted condition of the piston.

[0139] With reference to FIGS. 16 to 18, the shunt is advanced via a manual force applied by a surgeon on the slider block 72. Referring to FIG. 16, the shunt is initially wholly received within the lancet 48. The slider block is in a retracted position with the piston 70 in an extended position in abutment with the slider block. In this position, the stylet is received within the lumen of the distal tube 18. In order to advance the distal tube distally, the slider block 72 is displaced distally by the surgeon as is shown in FIG. 17, causing a distal end 92 of the stylet to exert a force on an inner side of the closed end of the distal tube, advancing the distal tube distally so that a distal end region of the distal tube projects from the lancet.

[0140] The distal stop formation 26 of the distal tube 18, being resiliently compressible, is compressed when the distal end of the shunt is received within the lancet. Upon advancement of the distal tube from the lancet, the distal stop formation expands, the outer diameter thereof being relatively larger than the outer diameter of the proximal stop formation 30 in its expanded configuration.

[0141] After implantation of the distal tube of the shunt into the subarachnoid space, the lancet of the shunt inserting device is retracted leaving the distal tube in its implanted condition. Referring to FIG. 18, the engagement projection 84 of the piston 70 is pushed inwardly causing the piston to be released from its engagement with the slider block thereby causing displacement, under the action of the coil spring, of the piston into its retraction position and thereby withdrawal of the stylet from the distal tube.

[0142] With reference to FIGS. 19A-19E, the manner in which the distal tube 18 of the shunt 10 is implanted in the subarachnoid space, is illustrated, in sequence. A passageway is created through orbital connective tissue surrounding the ocular orbit using an orbital retractor device 92. Once the passageway has been created, the lancet 48 of the shunt inserting device is inserted into the orbital retractor with a clear pathway defined to the optic nerve sheath (FIG. 19A). The tissue-penetrating tip 56 of the lancet is inserted through the optic nerve sheath D into the subarachnoid space B. During insertion, the stop formation 66 of the lancet abuts against an external side of the optic nerve sheath preventing over-insertion of the lancet (FIG. 19B). The slider block is displaced distally by the surgeon causing the distal end of the distal tube 18 of the shunt to be advanced into the subarachnoid space (FIG. 19C). The piston 50 of the shunt inserting device is thereafter disengaged from the slider block 72, causing retraction of the piston and withdrawal of the stylet 68. Upon withdrawal of the stylet, the support sleeve 95 supports the distal tube at its end 24 so as to prevent withdrawal of the distal tube along with the stylet. The shunt inserting device is then removed via the orbital retractor leaving the distal end of the distal tube implanted in the subarachnoid space with the remainder of the distal tube extending along a side of the orbital globe.

[0143] With reference to FIGS. 20A-20C, the proximal end of the proximal tube is implanted in the anterior chamber of the ocular globe, by initially creating a scleral channel through the sclera using a surgical blade 93 which enters the sclera about 4 mm from the limbus and exits the sclera at the trabecular meshwork (FIG. 20). Thereafter, the straight section 34 of the rigid proximal tube 20 is advanced along the scleral channel using forceps 94 (FIG. 20B). After implantation of the proximal end 12 in the anterior chamber the opposite end 22 of the proximal tube is inserted into the end 20 of the distal tube thereby forming the shunt between the anterior chamber and the subarachnoid space (FIG. 20C).

[0144] With reference to FIGS. 21 to 30, a second embodiment of a shunt in accordance with the invention, is designated by the reference numeral 100. The shunt 100 is similar to the shunt 10 with the only difference being that the distal tube has a different configuration at the distal end thereof. The proximal tube of the shunt 100 is the same as the proximal tube 20 of the shunt 10. In FIGS. 21 to 30, those features of the shunt 100 which are the same as and/or similar to those of the shunt 10 are designated by the same and/or similar reference numerals.

[0145] The shunt 100 comprises the rigid proximal tube 20 and a flexible distal tube 118 to which the proximal tube 20 is releasably connected. The distal tube 118 comprises an elongate flexible tubular body 105 of silicone rubber and a rigid implant body 106 of titanium, PEEK or other suitable material.

[0146] The rigid implant body 106 of the distal tube 118 defines a distal end 114 of the shunt 100. The distal tube 118 is connected to the proximal tube 20 at an opposite end 24 of the distal tube 118. More specifically, the end 22 of the proximal tube 20 is press-fitted into the open end 24 of the distal tube.

[0147] The distal tube 118 and the proximal tube 20 of the shunt 100, define a lumen 116 which extends continuously through the shunt between the distal end 114 and the proximal end 12 thereof.

[0148] The implant body 106 comprises a distal stop formation 126, a proximal stop formation 130 which is spaced from the distal stop formation and a narrower neck 107 which extends between the stop formations. The distal stop formation and the proximal stop formation define inwardly facing abutment faces 108 and 109, respectively, which abut inner and outer sides, respectively, of the optic nerve sheath when the distal stop formation 126 is implanted in the subarachnoid space as will be explained in more detail hereinbelow. A distal end region of the implant body is tapered towards the distal end 114 for facilitating advancement of the distal stop formation through a passageway created in the optic nerve sheath.

[0149] The abutment faces 108, 109, are disposed opposite one another and are obliquely slanted so as to conform to the curvature of inner and outer surfaces of the optic nerve sheath following implantation.

[0150] The invention extends to a shunt system including the shunt 100 and a shunt inserting device 140 for implanting the distal tube 118 in the subarachnoid space.

[0151] The shunt inserting device 140 comprises a tubular housing 142 and a distal inserting portion 146 mounted to the housing. The tubular housing provides a handle by which the shunt inserting device can be held.

[0152] The distal inserting portion includes an inner lancet 148 defining an internal passageway 150. The lancet has a distal end 152 which is identical to the distal end 52 of the shunt inserting device 40. As such, the lancet defines a tissue-penetrating tip 156 at the distal end for penetrating the optic nerve sheath for defining a passage therethrough through which the distal end of the implant body 106 can pass. The distal inserting portion further includes a tubular outer sleeve 181 within which the lancet is located in a spaced arrangement wherein the lancet and the outer sleeve are co-axially arranged and define an annular space 183 within which the tubular body 105 of the distal tube 118 is displaceably received.

[0153] The lancet 148 extends into the housing to a location at a proximal end region of the housing. The housing defines an inlet port 185 at a proximal end 187 thereof which is in fluid flow communication with the passageway 150 of the lancet, to which an outlet of a syringe 189 or the like, containing a gas or a liquid, can be connected.

[0154] With reference to FIGS. 28A-28E, the manner in which the distal tube 118 of the shunt 100 is implanted in the subarachnoid space, is illustrated, in sequence. A passageway is created through orbital connective tissue surrounding the ocular orbit using an orbital retractor device. Once the passageway has been created, the shunt inserting device 140 having the syringe 189 containing a biocompatible gas or liquid F connected thereto, is inserted (FIGS. 28A-28B) into the orbital retractor (not shown). The gas or liquid is introduced into the subarachnoid space via the lancet 148 by the surgeon by depressing the piston of the syringe thereby to displace the optic nerve sheath and the optic nerve away from one another so as to avoid the tissue-penetrating tip 156 of the lancet 148 accidentally piercing the optic nerve. The tissue penetrating tip 156 of the lancet is inserted through the optic nerve sheath D into the subarachnoid space B (FIGS. 28C-28CC). The shunt inserting device 140 is advanced distally until the distal stop formation 126 of the implant body 106 passes through the aperture defined in the optic nerve sheath by the tissue-penetrating tip 156 of the lancet 148 and the neck 107 of the implant body is located in the aperture in the optic nerve sheath. The implant body is now securely located within the optic nerve sheath with the opposing abutment faces 108 and 109 of the distal stop formation 126 and the proximal stop formation 130, respectively, abutting internal and external sides, respectively, of the optic nerve sheath. Thereafter the shunt inserting device 140 is withdrawn (FIG. 28D) leaving behind the distal tube 118 having its distal end 114 implanted in the subarachnoid space (FIG. 28E).