CN1895694A

CN1895694A - Subarachnoid epidural shunt

Info

Publication number: CN1895694A
Application number: CN 200610082096
Authority: CN
Inventors: B·J·格伦
Original assignee: Johnson and Johnson
Current assignee: Codman and Shurtleff Inc; Johnson and Johnson
Priority date: 2005-04-05
Filing date: 2006-04-05
Publication date: 2007-01-17

Abstract

Devices are provided for shunting fluid to treat hydrocephalous, and in particular for treating normal pressure hydrocephalous, or Alzheimer's, Idiopathic Intracranial Hypertension (IIH), or any other condition in which it is necessary to drain and/or cleanse CSF. The devices utilize a shunt having an inlet port, and outlet port, and a flow control component for controlling fluid flow from the inlet port to the outlet port. The shunt can be implanted at a location along or within a patient's spinal column. In one exemplary embodiment, an inlet port of a shunt can be implanted within the subarachnoid space, and an outlet port of a shunt can be implanted at a drainage site. In certain exemplary embodiments, the cerebrospinal fluid is drained into the epidural space.

Description

Subarachnoid epidural shunt

The cross-reference of related application

The present invention requires the applying date, and to be on April 5th, 2005, denomination of invention be the U.S. Provisional Application No.60/668 of " under the arachnoidea-epidural diverter ", 111 and to be on July 29th, 2005, denomination of invention be the U.S. Provisional Application No.60/703 of " under the arachnoidea-epidural diverter and improved CSF drainage device and method " applying date, 470 priority, the full content of above-mentioned application has been incorporated with for referencial use.

Technical field

The present invention relates to be used to shunt the method and apparatus of cerebrospinal fluid.

Background technology

Many situations are benefited from shunting, removal or the purification of CSF, comprise hydrocephalus, and pseudotumor cerebri (the special property intracranial hypertension of sending out, IIH) and Alzheimer (Alzheimer ' s) disease.For example, hydrocephalus is a kind of situation that torments a kind of like this patient, and described patient can not regulate self inherent path that cerebrospinal fluid flows through their health.The cerebrospinal fluid (CSF) that is produced by ventricular system is absorbed by the Venous system of health usually.In suffering from hydrocephalic patient, cerebrospinal fluid is not absorbed in this mode, but changes in the ventricles of the brain that are accumulated in patient's brain, and can cause serious medical conditions.

Hydrocephalus exists with two kinds of forms: the communicating hydrocephalus (non-obstructivity hydrocephalus) that is caused by insufficient absorption of CSF when ventricles of the brain path is not blocked; The noncommunicating hydrocephalus (obstructive hydrocephalus) that causes with obstruction in the ventricles of the brain path of flowing through by CSF wherein.Hydrocephalus also can be geneogenous, and wherein this situation just exists at birth or is found very soon afterwards, or posteriority, and wherein this situation is owing to infection, head trauma, cerebroma, cyst etc. obtain.Normal pressure hydrocephalus (NPH) is to occur in the adult, normally a kind of traffic (non-obstructivity) hydrocephalus in the middle of the old people.The drain of CSF is blocked gradually, and excessive fluid accumulates lentamente.It is believed that the ventricles of the brain when suffering from NPH enlarge handling the increase volume of CSF, and be full of the cerebral power that the fluidic ventricles of the brain produce and destroy or the infringement cerebral tissue, thereby cause some symptoms from inside.Be different from the hydrocephalus that typically causes other type that the pressure in the head increases when too much CSF accumulation, NPH has very little pressure to be increased even not to have pressure to increase, thereby is called as " normal pressure hydrocephalus ".

NPH can be by draining into other zone of patient body with excess fluid from ventricular system, for example abdominal part or vascular system and treated, and it can be absorbed in the blood flow again in described zone.The drainage system that is commonly called diverter usually is used to carry out fluidic transfer.It is made up of conduit system, and this conduit system has flowing controling part with control fluid conduction and anti-backflow.For diverter is installed, typically makes incision of scalp and in skull, get out aperture.The current diverter that is used for the treatment of NPH is inserted into by operation, thereby the upper end is communicated with ventricular system.Because NPH is non-obstructive, so the upper end of diverter or proximal catheter can be placed in the ventricles of the brain (ventricular catheter) or in the subarachnoid space of lumbar spinal column level (lumbar catheter).The lower end of diverter or distal catheter can import (ventriculo-peritoneal shunt device) in the abdominal part, and it enters blood flow at abdominal part.Exist other several body cavitys to can be used for the far-end shunting of diverter.When diverter was introduced into first, check valve directly drained into spinal fluid in the right atrium of heart (ventricles of the brain atrium diverter) through jugular vein.The work of vascular diverter is very good, but they are easy to produce various problems, comprise early stage and the later stage infection, and the clot granule that peels off owing to the catheter tip from diverter cause rare, the potential mortality heart failure that the obstruction of blood vessel causes in the lung.Because these problems, abandoned the use of heart in a large number as primary selection, but when infect or operation it remains the second feasible selection when causing the abdominal cavity to be not suitable for far-end diverter conduit.The thoracic cavity is can be as another chamber (ventricles of the brain thoracic cavity diverter) of the reserve chamber in abdominal cavity, and conduit is placed in the rib frame between the exodermis of its endodermis and lung.Sometimes, this chamber can not fast Absorption CSF, so lung is by excessive CSF extruding, thereby causes dyspnea.Conduit must be moved in the different chambeies under these circumstances.Rarely, conduit can rest on barrier film (muscle that is used to breathe in the bottom of lung), thereby causes stimulating and singultus.

Break through although diverter is great medical science, in hydrocephalic treatment, still have an open question, comprise that diverter blocks, infect and excessively drain.The success rate that NPH is shunted only is approximately 50%.Shift other situation for the treatment of by CSF, for example also there are these identical problems in pseudotumor cerebri.

Therefore, still need to be used for drain CSF with treatment hydrocephalus, pseudotumor cerebri (IIH) or must drain and/or the improving one's methods and equipment of purification CSF any other situation (may comprise Alzheimer).

Summary of the invention

Provide and be used to shunt so fluidic method and apparatus such as CSF.In one embodiment, provide a kind of shunting device, it comprises the shell with fluid intake and fluid issuing.Described fluid intake and outlet are separated a segment distance and place, make described fluid intake can be oriented to from receiving fluid such as the such cerebrospinal fluid source of the subarachnoid space of spinal column, and described fluid issuing can be oriented to transport fluid into the body cavity that can hold drainage of cerebrospinal fluid, for example epidural space of spinal column.Described shell also can comprise the flowing controling part that is arranged in wherein and is communicated with described fluid intake and outlet fluid, flow to described fluid issuing to be used to controlling fluid from described fluid intake.

Described shell can have various structures, but described in one embodiment shell can comprise from its extension and be suitable for being arranged in elongate member in the bone hole.Described elongate member can have various structures, and it can comprise first tube chamber and optional second tube chamber that is communicated with described fluid issuing fluid that is communicated with described fluid intake fluid.Described elongate member can comprise further feature, for example is suitable for promoting that bone inwardly grows into the outer surface in the described elongate member.For example, described elongate member can comprise bone composition surface feature or face coat.In other embodiments, described equipment also can comprise sleeve, and this sleeve is arranged and is suitable for and puts in the bone hole so that described elongate member is anchored in the described bone hole around described elongate member movably.Described sleeve can be included in its terminal go up form and be suitable for flange near bone surface.Described sleeve also can be included in the matching element that forms on its inner surface, and this matching element is suitable for cooperating movably the complementary matching element on the outer surface that is formed at described elongate member.

In another embodiment, described shell can comprise the core that is suitable for being arranged in the tube chamber, locatees described core is anchored at the described intraluminal first and second relative ends with the opposite end that is suitable near described tube chamber.Described fluid intake can be formed at first end of described shell, and described fluid issuing can be formed at second end of described shell.Described core can have various structures, but it can have the shape that is configured to be arranged in the intraluminal general cylindrical of general cylindrical in an exemplary embodiments.Described flowing controling part can be arranged in the inner chamber or perforate that is formed in the described core, and perhaps described perforate can form described flowing controling part and it can have and control fluid effectively and flow through wherein diameter.First and second ends of described shell also can have various structures, but first and second ends of described shell can be expandable in one embodiment.

On the other hand, provide a kind of separate system, it has diverter, and this diverter has first and second conduits and is connected between them to be used to control fluid flows to second conduit from first conduit flowing controling part.Described system also comprises the two-chamber sleeve pipe, and this two-chamber sleeve pipe has and extends through wherein to be used for admitting respectively first and second tube chambers of first and second conduits.First tube chamber can have opening, opening one segment distance of this opening in second tube chamber is positioned, make opening in the tube chamber of winning can be oriented to receive fluid from the subarachnoid space in the spinal column, the opening in second tube chamber can be oriented to transport fluid into the epidural space in the spinal column.In typical embodiment, the part of first tube chamber of contiguous described opening be bent with first catheter guidance in subarachnoid space, the part of second tube chamber of contiguous described opening be bent with second catheter guidance in epidural space.

The method that is used for shunting fluid also is provided, described in one embodiment method can comprise that the inlet of locating diverter is to receive the fluid from the subarachnoid space in the spinal column, with the location diverter outlet to transport fluid into the epidural space in the spinal column, make fluid be drained into the epidural space from subarachnoid space.Although diverter can have various structures, comprise with described entrance and exit fluid at an embodiment of diverter being communicated with to be used to control fluid flows to described outlet from described inlet flowing controling part.Described inlet can form at the end of first conduit that is connected to described flowing controling part, and described outlet can form at the end of second conduit that is connected to described flowing controling part.Locate described inlet and can comprise that formation enters the hole of subarachnoid space by dura mater, with at least a portion by location, the described hole in dura mater diverter described inlet is positioned to receive fluid from subarachnoid space, locate described outlet and can comprise that formation enters the bone hole of epidural space and locatees at least a portion of diverter so that described outlet is positioned to transport fluid into epidural space by the described bone hole in the lamina by lamina.In exemplary embodiments, diverter can comprise elongate member, and described inlet can extend in first tube chamber of described elongate member, and described outlet can extend in second tube chamber of described elongate member.Described elongate member can be inserted into by the described bone hole in the lamina.Insert described elongate member and can comprise that the sleeve in the described bone hole in making described elongate member and be positioned at lamina by screw thread cooperates.In other embodiments, locate described entrance and exit and can comprise that inserting the two-chamber sleeve pipe by tissue is positioned in the epidural space with the opening with first tube chamber of described element, and the opening of second tube chamber of described element is positioned in the subarachnoid space, with insert first conduit by first tube chamber and be positioned in the epidural space with a end with first conduit, and insert second conduit by second tube chamber and be positioned in the subarachnoid space with a end with second conduit.

Described method may further include near the described flowing controling part of spinal column anchoring.For example, described flowing controling part can be anchored to vertebra.Typical anchorage point comprises the spinous process of vertebra.In other embodiments, described flowing controling part can be anchored to vertebra soft tissue on every side.

In another embodiment, the method of shunting fluid is provided, this method comprises that the inlet with diverter is positioned at cerebrospinal fluid and can flows into the intravital position of patient of described inlet and the flowing controling part of diverter is anchored in the soft tissue around vertebra and the vertebra at least one.Described flowing controling part is disposed between the entrance and exit of diverter and flows to described outlet to be used to controlling cerebrospinal fluid from described inlet.Described method comprises further that the outlet with diverter is positioned at the cerebrospinal fluid that flows through from described outlet can be by the intravital position of the patient of drain.In some exemplary embodiments, described flowing controling part can be anchored to supraspinal position, spinous process for example, lamina, and transverse process.

Description of drawings

From the following specifically describes in conjunction with the accompanying drawings, will more fully understand the present invention, wherein:

Figure 1A is the side view of the mid portion of the human body that obtains along sagittal plane;

Figure 1B is the top view of the human body vertebral body that obtains along axial plane;

Fig. 2 is the side view of the part of spinal column, and it has shown a kind of method that is used for fluid is diverted to from subarachnoid space epidural space;

Fig. 3 A is the rearview of adjacent vertebral bodies, and it has shown the various anchorage points that are used for the anchoring diverter;

Fig. 3 B is the side view of the part of spinal column, and it has shown the various anchorage points that are used for the anchoring diverter;

Fig. 4 is the side view of the part of spinal column, and it has shown the another kind of method that is used for fluid is diverted to from subarachnoid space the drain position of health;

Fig. 5 is the side view of an embodiment that is used for first and second conduits are inserted into respectively the instrument of subarachnoid space and epidural space;

Fig. 6 is the side view of an exemplary embodiments that is used for fluid is diverted to from subarachnoid space the diverter of epidural space;

Fig. 7 is the top view of the another kind of diverter of Fig. 6, and this diverter has in the lamina that is arranged in wherein and is implanted to vertebra so that fluid is diverted to another embodiment of the flowing controling part the epidural space from subarachnoid space;

Fig. 8 is the top view of the diverter of Fig. 6, and this diverter has the tissue penetration tip of far-end, and is implanted in the lamina of vertebra so that fluid is diverted to the epidural space from subarachnoid space;

Fig. 9 is used for fluid is diverted to the top view of the another embodiment of the diverter that is positioned at intravital another drain position from subarachnoid space, and it has shown the diverter in the lamina that is implanted to vertebra;

Figure 10 A is the top view of vertebra, and it has shown the sleeve that is implanted in the lamina;

Figure 10 B is the top view of the vertebra of Figure 10 A, and it has shown and will be placed by the outer sleeve of Figure 10 A so that fluid is diverted to diverter the epidural space from subarachnoid space;

Figure 10 C is the top view of the vertebra of Figure 10 B, and it has shown by outer sleeve and is placed to be used for fluid is diverted to from subarachnoid space the diverter of epidural space;

Figure 11 A is the top view of vertebra, and it has shown the sleeve that is implanted in the lamina;

Figure 11 B is the top view of the vertebra of Figure 11 A, and it has shown and will be placed by the outer sleeve of Figure 11 A so that fluid is diverted to elongate member the epidural space from subarachnoid space;

Figure 11 C is the top view of the vertebra of Figure 11 B, and it has shown the elongate member by outer sleeve;

Figure 11 D is the top view of the vertebra of Figure 11 C, and it has shown will be connected to elongate member and telescopic diverter shell;

Figure 11 E is the top view of the vertebra of Figure 11 D, and it has shown and is connected to elongate member and outer sleeve to be used for fluid is diverted to from subarachnoid space the diverter shell of epidural space;

Figure 12 is implanted in the epidural space to be used for fluid is diverted to from subarachnoid space the side view of the diverter of epidural space according to another exemplary embodiments;

Figure 13 A is the side view with exemplary embodiments that is arranged in its telescopic diverter on every side; With

Figure 13 B is the side view of the diverter of the removed Figure 13 A of sleeve, and it has shown and is inflated diverter anchored to bone or to organize anchoring piece in the hole.

The specific embodiment

Some exemplary embodiments will be described now with the principle that structure, function, manufacturing and use to equipment disclosed herein are provided and the complete understanding of method.One or more examples of these embodiment shown in the drawings.Those of ordinary skill in the art will be understood that, specifically describe and equipment illustrated in the accompanying drawings and the determinate exemplary embodiments of method right and wrong at this, and scope of the present invention only is defined by the claims.Or the feature described shown in conjunction with exemplary embodiments can with the characteristics combination of other embodiment.Such modifications and variations mean within the scope of the present invention.

The method and apparatus that the invention provides shunting fluid is with treatment hydrocephalus, especially NPH, or Alzheimer, the special property sent out intracranial hypertension (IIH), or any other situation of necessary drain and/or purification CSF.Usually, described method is utilized diverter, and this diverter comprises inlet, outlet and be used to control fluid flows to outlet from inlet flowing controling part.Typical diverter will more specifically be discussed below.Described diverter can be implanted to along patient's spinal column or in the intravertebral position of patient.Figure 1A and 1B show human spine's arrowhead figure and axial view.As shown in Figure 1A, in typical embodiment, diverter is implanted in the lumbar vertebra, more preferably is implanted to the centre position in the lumbar vertebra, for example L3.This has been avoided contacting with the accident of spinal cord ideally.Yet described diverter can be implanted to any position of spinal column.Subarachnoid space S is shown in Figure 1B and extends through spinal canal along the length of spinal column.The inlet of diverter can be implanted near this space or wherein, and the outlet of diverter can be implanted to the drain position.Although the drain position can be any body cavity, it is preferably CSF can heavily be absorbed position in the blood flow directly or indirectly.For example, CSF can be drained into peritoneal cavity.Fluid is drained among the epidural space E in some exemplary embodiments.As shown in Figure 1B, epidural space E is around dura mater D, and dura mater is around subarachnoid space S.The specific implantation position of the flowing controling part of diverter also can change.In one embodiment, flowing controling part can be anchored to vertebra or vertebra soft tissue on every side.In other embodiments, flowing controling part can be implanted among the epidural space E or epidural space E and subarachnoid space S between dura mater D in, to be used for that fluid is diverted to epidural space E from subarachnoid space S, this will discuss below.

Fig. 2 shows an exemplary embodiments that is used for fluid is drained into from subarachnoid space S the diverter 10 of epidural space E.Diverter 10 generally includes first conduit 12 and second conduit, 14, the first conduits 12 to have and has the end that is formed at one or more fluid intake 12i, and second conduit 14 has and has the end that is formed at one or more fluid issuing 14o.Flowing controling part 16 is connected between first and second conduits 12,14 and it is controlled fluid effectively and flows to second conduit 14 from first conduit 12, controls CSF pressure thus.In fact any flowing controling part structure as known in the art can be used, and comprises the flow adjustment valve pin, differential valve, and slit valve, diaphragm valve has the valve of ball in the cone, have the valve of pin in the seat, adjustable valve, electronic control valve, Electronic Control pump etc.

As further shown in Figure 2, flowing controling part 16 can be anchored to vertebra V.The anchoring position can be any position on the vertebra V, yet typical anchoring position is shown in Fig. 3 A and 3B.Fig. 3 A shows the typical anchoring position A1 on the transverse process T, and A2, Fig. 3 B show anchoring position A3 on the spinous process SP of vertebra V and the anchoring position A9 in the vertebral body.In other embodiments, flowing controling part 16 can be disposed in or anchor to the soft tissue around the vertebra, the anchoring position A4 among the ligamenta flava F shown in Fig. 3 A for example, A5, or the anchoring position A6 among the ligamenta intervertebralia L shown in Fig. 3 B.Although soft tissue or bone can remain on the appropriate location with flowing controling part 16 effectively, can use various technology that flowing controling part 16 is anchored to vertebra V or vertebra soft tissue X on every side, comprise bone screw, suture, binding agent etc.

Although Fig. 2 shows second conduit 14 of fluid conduction to epidural space E, also can use intravital other drain position.Fig. 4 shows the diverter 10 of Fig. 2, this diverter have stretch out spinal column with fluid conduction to peritoneum or such as second conduit 14 at other such drain position of atrium or thoracic cavity.Second conduit 14 can extend to allow the outlet 14o on second conduit 14 to be implanted to intravital other position around vertebra.

Diverter also can use various technology implanted.In an exemplary embodiments as shown in Figure 2, first conduit 12 extends to the subarachnoid space S or at least near it by the ligamenta flava between the adjacent vertebrae from flowing controling part 16, and second conduit 14 extends to the epidural space E or at least near it by the ligamenta flava between the adjacent vertebrae from flowing controling part 16.Although conduit 12,14 only can use seal wire or other known technology to be conducted through described ligament, but Fig. 5 shows and is used for being directed among epidural space E and the subarachnoid space S first and second conduits 12,14 or a near exemplary embodiments of the instrument 20 it.As shown in the figure, instrument 20 adopts the telescopic form of hollow elongation, and this sleeve pipe has two

tube chambers

22,24 that extend through wherein.First tube chamber 22 has the localized outlet of the outlet 24o 22o of contiguous second tube chamber 24.As a result, when two-chamber sleeve pipe 20 was inserted into by ligament, the outlet 22o in first tube chamber 22 can be positioned near the of epidural space E or wherein, and the outlet 24o in second tube chamber 24 can be positioned near the of subarachnoid space S or wherein.One skilled in the art will appreciate that the outlet 22o of each

tube chamber

22,24, the distance between the 24o can be suitable for obtaining to use the desired result of this equipment.As further shown in Figure 5, near outlet 22o, the distal portions 22d of each

tube chamber

22,24 of 24o, 24d can comprise help catheter guidance in epidural space E and subarachnoid space S or near the feature it.In exemplary embodiments, near outlet 22o, the conduit that the part 22d of each tube chamber of 24o, 24d are bent will insert wherein rotates about 90 °, and guide catheter makes it axially to extend along patient's spinal column thus.

In other embodiments, be different from and flowing controling part anchored to vertebra or soft tissue and conduit is extended among epidural space E and the subarachnoid space S or near it, diverter can be configured to directly anchor to lamina, or be implanted among the epidural space E or epidural space E and subarachnoid space S between dura mater D in.Fig. 6-11 shows and is used for diverter is implanted to lamina, various exemplary embodiments and technology among epidural space E or the dura mater D.

In exemplary embodiments shown in Figure 6, diverter 30 generally includes shell 32, the elongate member 34 that this shell has from its extension and is configured to be placed by bone.Shell 32 can have different shape and size, but it is preferably suitable for keeping flowing controling part 36 therein, and this will discuss below.In an illustrated embodiment, shell 32 has hollow substantially cylindrical shape, and elongate member 34 is from the remote extension of shell 32.Elongate member 34 can have various structures, shape and size, and it can be inflexible, semirigid or flexible.For example, elongate member 34 can adopt rigid needle or sleeve pipe, or such as the form of the so flexible tube-like piece of conduit.In the embodiment shown in fig. 6, elongate member 34 adopts the telescopic form that is suitable for being placed in the bone hole.Elongate member 34 can form with shell 32, and perhaps it can removably be connected to shell 32.For example, joint or other bindiny mechanism can be formed on the near-end of elongate member 34 to be used for removably elongate member 34 being connected to shell 32.Elongate member 34 also can be included in and wherein form and have first tube chamber 38 of fluid intake 38i and form and have second tube chamber 39 of fluid issuing 39o therein.Fluid intake 38i and outlet 39o can be positioned near the of subarachnoid space S or wherein to allow fluid intake 38i along axis each interval one segment distance of elongate member, while fluid issuing 39o is positioned near the of epidural space E or wherein, this will more specifically describe below.Although can use various technology will enter the mouth 38i and the outlet 39o be positioned to each interval one segment distance, first tube chamber 38 extends beyond second tube chamber, 39 1 segment distances in the embodiment shown in fig. 6.As a result, the inlet 38i in contiguous first tube chamber 38 of the outlet 39o in second tube chamber 39.As further shown, first tube chamber 38 extends through second tube chamber 39 and makes that

tube chamber

38,39 is coaxial.Yet,

tube chamber

38,39 can be placed side by side or they can have various other structures.

In order to allow fluid to flow through diverter 30,

tube chamber

38,39 can be communicated with flowing controling part 36 fluids that are placed between them.As shown in Figure 6, flowing controling part 36 is disposed in the proximal part of shell 32 and is oriented to control fluid and flows to second tube chamber 39 from first tube chamber 38.Especially, first tube chamber 38 directly extends to flowing controling part 36 in the shell 32 by elongate member 34.So fluid can directly flow in second tube chamber 39 by flowing controling part 36.In fact flowing controling part 36 can have any structure as known in the art.In an illustrated embodiment, bellows valve is used to control fluid and flows through wherein.Fig. 7 and 8 show have flowing controling part 36 ' the diverter of Fig. 6 of another embodiment, the form that described flowing controling part adopts the flow adjustment pin be used for regulated fluid flow through flowing controling part 36 '.As the example of indefiniteness, the type of other typical flowing controling part comprises differential valve, slit valve, and diaphragm valve has the valve of ball in the cone, have the valve of pin in the seat, adjustable valve, electronic control valve, Electronic Control pump etc.

In use, with reference to figure 7 and 8, diverter 30 is suitable for implanted, make inlet 38i be disposed near the of subarachnoid space S or wherein, and outlet 39o is disposed near the of epidural space E or wherein, allow CSF to pass through to flow in second tube chamber 39 in flowing controling part 36 ' inflow first tube chamber 38 thus, 39o flows out into epidural space E from outlet.Although diverter 30 can be implanted to all places and be positioned at the position of expectation with will enter the mouth 38i and outlet 39o, diverter 30 is implanted among the lamina B in exemplary embodiments.Fig. 3 A shows two anchoring position A7 among the lamina B, A8.Later with reference to figure 7 and 8, the bone hole can be formed among the lamina B and elongate member 34 can be by wherein being inserted into.Various technology can be used for diverter 30 is anchored to lamina B.For example, the outer surface of elongate member 34 can comprise screw thread or formed thereon and be configured to other surface character of the bone around the zeugopodium hole.Elongate member also can or alternately comprise face coat, for example porous coating or hydroxyapatite.As another selection, as shown in Fig. 6-8, prolate body or sleeve are for example managed screw 40, can implanted lamina B in to be used for anchoring diverter 30.The size of pipe screw 40 is determined to be and is suitable for being placed in the bone hole, and it can comprise flange 42, this flange on the one end, forms and be suitable near near the bone surface in bone hole to prevent that managing screw 40 passes through the bone hole.Pipe screw 40 also can comprise formed thereon to be used for screw 40 is screwed into the screw thread in bone hole, and perhaps it can use other technical battery as known in the art to receive lamina B.In exemplary embodiments, pipe screw 40 has been attacked screw thread, and the screw applicator is used for screw 40 is screwed in the bone hole that is formed at lamina B.Elongate member 34 can be inserted into will enter the mouth 38i and outlet 39o by pipe screw 40 and be positioned at respectively among subarachnoid space S and the epidural space E or near it.In an exemplary embodiments, elongate member 34 can comprise matching element formed thereon, and screw thread for example is to be used for cooperating the complementary matching element of the inner chamber that is formed at pipe screw 40.When needs, such structure allows diverter 30 to be removed and/or to replace.

For will enter the mouth 38i and outlet 39o are positioned among subarachnoid space S and the epidural space E or near it, elongate member 34 need extend through the dura mater D between subarachnoid space S and epidural space E.In an embodiment as shown in Figure 7, the distal-most end of elongate member 34 can comprise blunt most advanced and sophisticated 34a.Various technology and equipment as known in the art can be used for being directed among the subarachnoid space S in dura mater D formation perforation and/or with blunt most advanced and sophisticated 34a.Select as another, the distal-most end of elongate member 34 can comprise tissue penetration formed thereon as shown in Figure 8 most advanced and sophisticated 34t, for example tip or thorn-like tip.Most advanced and sophisticated 34t can be used to pierce through dura mater D when diverter 30 is implanted.

In case diverter 30 is implanted, as shown in Fig. 7 and 8, the CSF fluid that flows through subarachnoid space S will flow among the inlet 38i of first tube chamber 38, and flowing out outlet 39o in second tube chamber 39 directly to be transported among the epidural space E, at least some among the CSF can heavily be absorbed in the blood back stream thus.Flowing controling part 36, the 36 ' fluid of diverter 30 is flow through in adjusting is controlled CSF pressure thus.

Fig. 9 shows another embodiment of the diverter 50 that is used for the treatment of CSF.In this embodiment, diverter 50 is suitable for being implanted among the lamina B so that CSF is drained into intravital other position from subarachnoid space S.Especially, diverter 50 comprises shell 52, and this shell has from its extension and is suitable for extending to elongate member 54 the subarachnoid space S.Shell 52 is similar to the described shell 32 about Fig. 6, and comprises to be arranged in wherein to be used to control fluid and flow through wherein flowing controling part 56.On the other hand, elongate member 54 only comprises and extends through one of them tube chamber 58.Tube chamber 58 is included in the inlet 58i of its distal-most end, and the fluid that flows through tube chamber 58 is transported to flowing controling part 56.Be different from and have the return cavity that is used to transport fluid into epidural space E, outlet 52o can form in shell 52 and conduit 60 can connect with it.Conduit 60 can be transported to intravital another drain position, for example peritoneal cavity from outlet 52o with fluid.Those skilled in the art will appreciate that shell 52 and elongate member 54 can have various other shape and size, and they can form one or cooperation movably each other each other.

In use, identical with the embodiment shown in Fig. 7 and 8, by elongate member 54 is inserted by the bone hole that is formed among the lamina B, the diverter 50 of Fig. 9 can be implanted among the lamina B.Elongate member 54 can directly cooperate lamina B, and perhaps it can cooperate the sleeve that is placed in the bone hole, for example previously described pipe screw 40.The far-end of elongate member 54 is configured to extend through dura mater D, thereby it can use various technology as known in the art to be inserted into by the preformed perforation that is formed among the dura mater D, and perhaps it can comprise that tissue penetration tip formed thereon is to be used to pierce through dura mater D.The conduit 60 that extends from outlet 52o can around the adjacent vertebrae or between extend to be positioned at intravital another drain position.

The ad hoc approach that one skilled in the art will appreciate that the implantable shunt device will depend on whether the particular configuration of diverter and diverter comprise one, two still three elements and changing.For example, with reference to the diverter 30 of figure 6, shell 32 and elongate member 34 can form the discrete component that can directly be implanted in the lamina with shunting fluid.As another selection, diverter 30 can have two-piece construction, and wherein shell 32 and elongate member 34 form first element, form second element such as the sleeve of managing screw 40, and perhaps wherein shell 32 forms first element, and elongate member 34 forms second element.In another embodiment, diverter 30 can have the three-member type structure, and this structure comprises shell 32, and independent elongate member 34 and independent sleeve are for example managed screw 40.Therefore, the method for implantable shunt device will depend on the structure of diverter and change.As the indefiniteness example, Figure 10 A-10C shows a typical method that is used to implant the two-piece type diverter, and Figure 11 A-11E shows with a typical method implanting the three-member type diverter.

Figure 10 A shows vertebra, and this vertebra comprises vertebral body VB, spinous process SP, lamina L and subarachnoid space S.Epidural space E is the zone around subarachnoid space S.As shown in Figure 10 A, perforate can be formed in the lamina and sleeve 110 can be implanted in the perforate to form the path by lamina.Diverter 120 has diverter shell 122 that comprises the flowing controling part (not shown) and the elongate member 124 that extends from diverter shell 122, and as shown in Figure 10 B and 10C, it can be inserted in the sleeve 110 and cooperate with it.Elongate member 124 will extend among the subarachnoid space S, flow in elongate member 124 and the diverter shell 122 to allow CSF.Flowing controling part in the diverter shell 122 will be re-directed to CSF and be formed in the diverter and be positioned at one or more outlets among the epidural space E, thus CSF be drained into epidural space E from subarachnoid space S.

Show vertebra like Figure 11 category-A, this vertebra comprises vertebral body VB, spinous process SP, lamina L and subarachnoid space S.Epidural space E is the zone around subarachnoid space S.As shown in the figure, perforate can be formed in the lamina and sleeve 210 can be implanted in the perforate to form the path by lamina.Elongate member 212, for example intubate or conduit can be inserted in the sleeve 210, as shown in Figure 11 B and 11C.As a result, elongate member 212 will have first end of the outside that extends to sleeve 210 and extend to second end among the subarachnoid space S, flow in the elongate member 212 to allow CSF.Three element adopts the form of the diverter shell 214 that wherein has flowing controling part, as shown in Figure 11 D and 11E, it can be connected to sleeve 210 to receive CSF from elongate member 212 and CSF is re-directed to the epidural space E then, thus CSF is drained into epidural space E from subarachnoid space S.CSF can flow through second outlet plenum that is formed in the elongate member 212, and it can flow between elongate member 212 and sleeve 210, and perhaps it can flow through the pipeline in the sleeve.It will be apparent to one skilled in the art that the screw thread that can use other compounding technique makes diverter shell 214 cooperate sleeve 210.Diverter shell 214 also can cooperate or engage the near-end of elongate member 212 so that elongate member 212 is remained on wherein.

As mentioned above, diverter can be implanted in the dura mater D between subarachnoid space S and the epidural space E in other embodiments.Figure 12 shows an embodiment of such diverter 70.As shown in the figure, diverter 70 is similar to the diverter 50 of Fig. 9, and comprises shell 72 with the flowing controling part 76 that is placed on wherein and the elongate member 74 that extends and have the tube chamber 78 that is communicated with flowing controling part 76 fluids from shell 72.Inlet 74i forms in the far-end of elongate member 74, one or

more outlet

72a, and 72b can form in shell 72.In this embodiment, elongate member 74 diverter 50 than Fig. 9 on length is short, and this is because it only need extend through dura mater D, and does not need the same as lamina B, epidural space E and dura mater D with the embodiment of Fig. 9.Diverter 70 does not comprise conduit yet, and this is that 72b can be directly released into fluid among the epidural space E because export 72a.

In use, as shown in the figure, diverter 70 is implanted among the epidural space E, and elongate member 74 is positioned by dura mater D, makes inlet 74i be positioned near the of subarachnoid space S or wherein.As previously described, can use equipment as known in the art come perverse wear dura mater D and/or with elongate member 74 guiding by wherein, perhaps elongate member 74 can comprise the tissue penetration tip that forms thereon.For diverter 70 is anchored among the epidural space E, elongate member 74 can comprise that the surface character and/or the coating that form or arrange move from dura mater D to prevent it thereon, and perhaps shell 72 can use suture, and bone screw or other compounding technique are connected to dura mater D.In case diverter 70 is implanted, CSF can flow through diverter 70 from subarachnoid space S, in diverter 70 it be released in a controlled manner epidural space E near or wherein.

Figure 13 A and Figure 13 B show another embodiment of the diverter that can be implanted among the dura mater D.Although diverter can have various structures, diverter 80 adopts the form of tubular body as shown in the figure, and this tubular body has the tube chamber 82 that extends through wherein between inlet 80i and outlet 80o.Tube chamber 82 serves as fluid and flow into pipeline the epidural space E from subarachnoid space S.Tube chamber 82 can comprise the flowing controling part that is placed on wherein, and perhaps tube chamber 82 can form flowing controling part.For example, tube chamber can have size and is suitable for regulated fluid and flows through wherein diameter.Check valve such as duckbill valve 84 can be formed in the tube chamber 82 to be used for preventing that fluid from flowing into subarachnoid space S.

Diverter 80 also can be included on its each end the anchoring piece that forms or connect with its each end to be used for that diverter 80 is anchored to dura mater D.Anchoring piece can have various structures, but anchoring piece is expandable in exemplary embodiments.For example, each anchoring piece can adopt the form of inflatable air bag.In the embodiment shown in Figure 13 A and the 13B, anchoring piece is inflatable ring 86,88, and it is connected to diverter 80 and around its layout, and is formed by shape-memory material, Nitinol (Nitinol) for example, thereby anchoring piece 86,88th, self-expanding.Sleeve pipe 90 such sleeves shown in Figure 13 A can be arranged anchoring piece 86,88 is remained on initial not expanded configuration around diverter 80.In case sleeve 90 is inserted among the dura mater D or by it and is inserted into, sleeve 90 can be contracted, and perhaps diverter 80 can be pushed out sleeve 90, expands to allow anchoring piece 86,88, as shown in Figure 13 B.Diverter 80 is positioned such that an anchoring piece 88 is disposed near the of subarachnoid space S or wherein, and another anchoring piece 86 is disposed near the of epidural space E or wherein.As a result, anchoring piece 86,88 will be bonded on the dura mater D between them, thus diverter 80 will be anchored among the dura mater D.Those skilled in the art will appreciate that and to use various other anchorage technologies, and diverter can be formed under the situation of not using anchoring piece and remains among the dura mater D in other embodiments.Suture, binding agent or other technology also can or alternatively be used.

Those skilled in the art will understand further feature and advantage of the present invention based on embodiment described above.Therefore, the present invention also can't help by the content constraints that specifically shows and describe, but is represented by appended claim.Clearly be incorporated herein by reference in full at these all public publications quoted and list of references.

Claims

1. shunting device, it comprises:

Shell with fluid intake and fluid issuing, described fluid intake and outlet are separated a segment distance and place, make that described fluid intake can be oriented to receive fluid from the subarachnoid space of spinal column, and described fluid issuing can be oriented to transport fluid into the epidural space of spinal column, described shell further comprises the flowing controling part that is arranged in wherein and is communicated with described fluid intake and outlet fluid, flow to described fluid issuing to be used to controlling fluid from described fluid intake.

2. according to the equipment of claim 1, wherein said shell is suitable for being positioned at substantially the position from following group selection, comprising: the bone hole in the vertebra, epidural space, dura mater, and subarachnoid space.

3. according to the equipment of claim 1, wherein said shell is suitable for being arranged in substantially the soft tissue near spinal column.

4. according to the equipment of claim 1, wherein said shell comprises from its extension and is suitable for being arranged in elongate member in the bone hole.

5. according to the equipment of claim 4, wherein said elongate member comprises the pin of the tissue that is suitable for puncturing.

6. according to the equipment of claim 4, wherein said elongate member comprises first tube chamber that is communicated with described fluid intake fluid and second tube chamber that is communicated with described fluid issuing fluid.

7. according to the equipment of claim 4, further comprise sleeve, this sleeve is arranged and is suitable for and puts in the bone hole so that described elongate member is anchored in the described bone hole around described elongate member movably.

8. according to the equipment of claim 7, wherein said sleeve is included in the matching element that forms on its inner surface, and this matching element is suitable for cooperating movably the complementary matching element on the outer surface that is formed at described elongate member.

9. according to the equipment of claim 1, wherein said shell comprises the core that is suitable for being arranged in the tube chamber, locate described core is anchored at the described intraluminal first and second relative ends near the opposite end of described tube chamber with being suitable for, described fluid intake is formed at first end of described shell, and described fluid issuing is formed at second end of described shell.

10. according to the equipment of claim 9, first and second ends of wherein said shell are expandable.

11. a separate system, it comprises:

Diverter, this diverter have first and second conduits and are connected between them to be used to control fluid flows to second conduit from first conduit flowing controling part; With

The two-chamber sleeve pipe, this two-chamber sleeve pipe has and extends through wherein to be used for admitting respectively first and second tube chambers of first and second conduits, first tube chamber has opening, opening one segment distance of this opening in second tube chamber is positioned, make opening in the tube chamber of winning can be oriented to receive fluid from the subarachnoid space in the spinal column, the opening in second tube chamber can be oriented to transport fluid into the epidural space in the spinal column.

12. system according to claim 11, the part of first tube chamber of wherein contiguous described opening be bent with first catheter guidance in subarachnoid space, the part of second tube chamber of contiguous described opening be bent with second catheter guidance in epidural space.

13. a method that is used for shunting fluid, it comprises:

The inlet of location diverter is to receive the fluid from the subarachnoid space in the spinal column; With

The outlet of location diverter makes fluid be drained into the epidural space from subarachnoid space to transport fluid into the epidural space in the spinal column.

14. according to the method for claim 13, wherein diverter comprises the flowing controling part that is communicated with described entrance and exit fluid, this flowing controling part control fluid flows to described outlet from described inlet.

15. according to the method for claim 14, wherein said inlet forms at the end of first conduit that is connected to described flowing controling part, described outlet forms at the end of second conduit that is connected to described flowing controling part.

16. method according to claim 13, wherein locate described inlet and comprise that formation enters the hole of subarachnoid space by dura mater, with at least a portion by location, the described hole in dura mater diverter described inlet is positioned to receive fluid from subarachnoid space, wherein locate described outlet and comprise that formation enters the bone hole of epidural space and locatees at least a portion of diverter so that described outlet is positioned to transport fluid into epidural space by the described bone hole in the lamina by lamina.

17. method according to claim 16, wherein diverter comprises elongate member, described inlet extends in first tube chamber of described elongate member, and described outlet extends in second tube chamber of described elongate member, and wherein said elongate member is inserted into by the described bone hole in the lamina.

18., wherein insert described elongate member and comprise that the sleeve in the described bone hole in making described elongate member and be positioned at lamina by screw thread cooperates according to the method for claim 17.

19., wherein locate described entrance and exit and comprise according to the method for claim 13:

Insert the two-chamber sleeve pipe by tissue and be positioned in the epidural space, and the opening of second tube chamber of described element is positioned in the subarachnoid space with opening with first tube chamber of described element;

Insert first conduit by first tube chamber and be positioned in the epidural space, and insert second conduit by second tube chamber and be positioned in the subarachnoid space with a end with second conduit with a end with first conduit.

20., further comprise near the described flowing controling part of spinal column anchoring according to the method for claim 14.

21. according to the method for claim 20, wherein said flowing controling part is anchored to vertebra.

22. according to the method for claim 20, wherein said flowing controling part is anchored to the spinous process of vertebra.

23. according to the method for claim 20, wherein said flowing controling part is anchored to the soft tissue around the vertebra.

24. a shunting device, it comprises:

Shell, this shell has at least a portion that is configured to be placed in the bone hole, and have therein form and fluid intake in being formed at shell and fluid issuing between the fluid flow path of extending, described fluid intake and outlet are separated a segment distance and place, make described fluid intake can be positioned near the cerebrospinal fluid source, and described fluid issuing can be positioned near the body cavity that can hold drainage of cerebrospinal fluid, and described fluid flow path is configured to control fluid and flows between described fluid intake and outlet.

25. according to the equipment of claim 24, wherein said shell comprises from its extension and is suitable for being arranged in elongate member in the bone hole.

26. according to the equipment of claim 25, wherein said elongate member cooperates described shell movably.

27. according to the equipment of claim 25, wherein said fluid intake and outlet form in described elongate member.

28. equipment according to claim 27, wherein said fluid flow path comprises second tube chamber that extends through described elongate member and first tube chamber that is communicated with described fluid intake fluid and extend through described elongate member and be communicated with described fluid issuing fluid.

29. according to the equipment of claim 25, further comprise sleeve, this sleeve is arranged and is suitable for and puts in the bone hole so that described elongate member is anchored in the described bone hole around described elongate member movably.

30. according to the equipment of claim 29, wherein said sleeve be included in its terminal go up form and be suitable for flange near bone surface.

31. according to the equipment of claim 29, wherein said sleeve is included in the matching element that forms on its inner surface, this matching element is suitable for cooperating movably the complementary matching element on the outer surface that is formed at described elongate member.

32. equipment according to claim 24, wherein said shell comprises the core that is suitable for being arranged in the bone hole, locate described core is anchored at the first and second relative ends in the described bone hole near the opposite end in described bone hole with being suitable for, described fluid intake is formed at first end of described shell, and described fluid issuing is formed at second end of described shell.

33. according to the equipment of claim 32, wherein said flowing controling part comprises perforate, this perforate extends through described core and has and controls fluid effectively and flow through wherein diameter.

34. according to the equipment of claim 32, first and second ends of wherein said shell are expandable.

35. a shunting device, it comprises:

Sleeve, it is suitable for being anchored in the bone hole and has the tube chamber that extends through wherein;

Shell, it has therein the fluid flow path that forms and is arranged in the described fluid flow path to be used to control fluid and flows through wherein flowing controling part, with extend from described shell and be movably disposed within intraluminal elongate member the described sleeve, described elongate member comprises the entrance and exit that is communicated with fluid flow path fluid in the described shell.

36. according to the shunting device of claim 35, wherein said elongate member cooperates described shell movably.

37. according to the shunting device of claim 35, the described entrance and exit in the wherein said elongate member axially is arranged along the length of described elongate member separated from one anotherly.

38. according to the shunting device of claim 35, wherein said inlet is formed at the far-end of described elongate member, and described elongate member comprises by wherein extend to first tube chamber of the fluid flow path the described shell from described inlet.

39. according to the shunting device of claim 38, wherein said outlet is contiguous described goes into interruption-forming.

40. the method for a shunting fluid, it comprises:

The inlet of diverter is positioned at the intravital position of patient that cerebrospinal fluid can flow into described inlet;

The flowing controling part of diverter is anchored to vertebra, and described flowing controling part is disposed between the entrance and exit of diverter and flows to described outlet to be used to controlling cerebrospinal fluid from described inlet; With

The outlet of diverter is positioned at the cerebrospinal fluid that flows through from described outlet can be by the intravital position of the patient of drain.

41. method according to claim 40, wherein the anchoring flowing controling part comprises sleeve is implanted in the bone hole that is formed in the vertebra, the elongate member that wherein is formed with inlet is inserted in the described sleeve, make fluid to flow into the shell from described inlet, this shell is connected to described elongate member and has the flowing controling part that is arranged in wherein.

42. method according to claim 40, wherein the anchoring flowing controling part comprises sleeve is implanted in the bone hole that is formed in the vertebra, the elongate member that wherein is formed with inlet is inserted in the described sleeve, with will have the shell that is arranged in flowing controling part wherein and be connected to described elongate member, make the inlet of fluid from described elongate member flow in the described shell.

43. according to the method for claim 40, wherein said flowing controling part is anchored to supraspinal position, described position is selected from down group: spinous process, lamina, and transverse process.