CN105919723A - Non-invasive adjustable drainage equipment - Google Patents

Abstract

The equipment disclosed by the invention comprises at least one inlet tube (1) which serves as a drainage fluid passage, and the tube (1) is connected to a cavity (2), and the cavity (2) comprises rotating devices (4, 5) for regulating a flow velocity in the tube.

Description

Non-invasively adjustable drainage device

The application is Application No. 200780101682.3, filing date on November 23rd, 2007, denomination of invention Divisional application for the application for a patent for invention of " non-invasively adjustable drainage device ".

Technical field

The present invention relates to the implantable adjustable drainage device for drainage fluid.Specifically, the present invention relates to And non-invasively adjustable drainage device, for example, this drainage device is used for treating glaucoma.

Background technology

In prior art, particularly in the field for the treatment of glaucoma, existing implantable adjustable drainage device.

Glaucoma is the disease relevant with ocular hypertension, is characterized in damaging optic nerve, thus causes vision Lose, be initially to lose peripheral visual acuity, if but state of an illness sustainable development, then may cause blind.Sorry , the patient of suffering from glaucoma is typically the most asymptomatic, until the late period of disease.Green light eye shadow Ring the whole world about seven million people.

The traditional treatment of glaucoma is the product being reduced ophthalmic liquid (aqueous humor) by medicine (such as eye drop) Raw, in some cases, this treatment is invalid, thus preferably by other therapeutic method of surgery, Such as filter or storing have the Glaucoma Drainage equipment (GDD) of drainage tube.GDD is by providing Artificial drainage path contributes to discharging ophthalmic liquid, thus maintains ocular hypotension (IOP).

Generally, GDD is inserted by the little otch being positioned on conjunctiva.Then, surgeon is in the Gong of eyes Cut minimum otch on film and form the weapon implanting equipment for drain.Put drainage tube and make tubule Opening be positioned at the anterior chamber of eye, wherein, the opening of tubule immerses in aqueous humor.Manage and be attached to eyes Episcleral drainage device is sewed up in position.Most of surgeon will be able to can absorb when operation Stitching thread is arranged in the surrounding of pipe in case stop-pass is crossed this equipment and filtered, until forming fibrous capsule.With regard to this point For, until this program about 3-8 week, this equipment is just expected to work.It is thought that this technology Excessively filter for preventing.

The passive drainage device of glaucoma of the prior art in the United States Patent (USP) 4,457,757 of Molteno Describe.Specifically, the equipment of Molteno includes the pipe being made up of biologically inert silicone tube, and this pipe is inserted into eye Interior with from anterior chamber's drain aqueous humor of eyes.This equipment does not have pressure-regulating device and only relies only on pipe The pressure regulation that the resistance of liquid stream provides.

One subject matter of this equipment is: equipment is completely passive, i.e. drain flow depends on IOP Fixing hydrodynamic resistance with branch.But, in many cases, the hydrodynamic resistance of branch may not It is preferable, when resistance height, high IOP may be caused, if resistance is low, then may cause excessive drain.

Having realized that this problem in prior art, some publications relate to the improvement of known device, thus Can control and adjust flow.

The United States Patent (USP) 5,411,473 of Ahmed shows another example.In that patent, conception be for Drainage device increases a system, and wherein, this system has that fold between the two plates and is in and draws Stretch the film of state, thus slit opening is provided.Film changes in response to pressure to open or close slit opening. All features of this system are attributes based on film self, and can not change this element easily.

The United States Patent (USP) 5,300,020 of L'Esperance shows another example, and wherein, drainage system includes Volume control device.In that patent, described device is that the form of the stopper maintaining anterior chamber pressure presents , this stopper is made up of the absorbable material with porosity characteristic.Once aqueous humor is all absorbed into plug Son, the path towards the relatively slow drain fluids of subconjunctival space is just established, and puts down until forming pressure Weighing apparatus.Pressure release is enough slowly to avoid cornea to wither, but be enough to reduce intraocular pressure.

As be readily appreciated that, the defect of this scheme is that it has certain inertia and flow velocity can Can will not change due to the difference of situation.

In another embodiment disclosed in this patent, this system includes having time-delay valve Unclosing structure Flexible drainage tube.This structure includes the ball with biocompatibility absorbable material, and this ball is as at pipe Upper applying makes the device of the extruding of valve closing.Gradually dissolve the material of ball due to body fluid, the valve of ball cuts out Power reduce, thus create the condition that valve is opened.In another embodiment, valve opens knot Structure includes polymer element, and its (due to reason or reason of preparation especially of material itself) is selectivity Collapsible or extensile to realize opening and/or shutoff operation of valve arrangement,

In this embodiment, As time goes on, it is clear that be difficult to the essence of the flow velocity to drain Really regulation, and once ball is dissolved, and the most again can not regulate flow.

The publication of following prior art disclose other examples: US 5,626,558, US 6,186,974, US 6,508,779 or US 6,726,664.

The United States Patent (USP) 6,077,299 of Adelberg et al. discloses a kind of for drain aqueous humor in glaucoma Non-intrusion type adjustable valve implant.One purpose of equipment disclosed in this patent is to provide one can The implant of discharge characteristic is adjusted in non-intrusion type mode.More specifically, this equipment includes having inlet tube Implant, by operation inlet tube inserted in the anterior chamber of eyes, to allow aqueous humor to flow to valve from anterior chamber Door.After by the pressure in implant and/or flow control valve, liquid divides along the periphery of implant Being scattered to the inside of ocular capsule (Tenon's capsule), at ocular capsule, liquid is absorbed by health. In one embodiment, valve is forbidden between the bubble cavity pressure that liquid is less than intraocular pressure and ocular capsule Certain pressure difference and allow liquid to be higher than this certain pressure difference.This certain pressure difference or set point are the most just Value, for negative pressure differential, valve be always off to prevent the liquid countercurrent of ocular capsule from returning to eyes Anterior chamber.

In that patent, the chamber that valve is connected by inlet tube is formed, the flexible material of flat cone-shaped (as Silicon) pressure sensitive valve made cuts out described chamber.The pressure regulation set point of valve depends on and strengthens The flexible membrane that plate coordinates, reinforcing plate has inclined-plane, and this inclined-plane is configured to slip over and is attached on diaphragm Complementary bevel.The inclined-plane of plate and the cooperation of complementary bevel make diaphragm inclined according to reinforcing plate location Tiltedly.Reinforcing plate self rotates to reduce rotating speed by rotor and one group, institute implemented by the gear of increase moment of torsion State regulation.

As be readily appreciated that, the feature of valve is heavily dependent on a conical-shaped valve element. Additionally, adjusting means includes many rotary parts and the gear implementing this device, cause its manufacture the most multiple Miscellaneous.Additionally, due to there is a large amount of movable part, therefore there is also the risk of device fails.

The United States Patent (USP) 6,168,575 and 6,589,198 of Soltanpour et al. discloses Micropump assembly, this Micropump Assembly can implanted ophthalmic controllably to get rid of unnecessary liquid from eyes, thus treat glaucoma.At this In a little patents, the pump of implantation has the variable pumping that manually or automatically can regulate according to intraocular pressure Speed.The defect of this equipment is in particular, in that it is complicated and expensive.It is true that this equipment must comprise institute Having required element, especially electronic device and power supply, owing to this equipment is to implant, these elements must Must be small-sized and be comprised in sealing shell in.Owing to there is a large amount of common different elements coordinated, because of This, too increase the risk broken down.

Summary of the invention

Therefore, it is an object of the invention to improve known equipment and system.

It is a further object to provide a kind of less GDD of parts easily operated, that use to set Standby.

A further object of the present invention is to provide a kind of being simple to manufacture and cheap GDD equipment

Accompanying drawing explanation

By description and the following accompanying drawing of some embodiments, it is better understood with the present invention:

Fig. 1 shows first embodiment of the present invention；

One example of the external control devices shown in Fig. 2；

Fig. 3 shows second embodiment of the present invention；

Fig. 4 shows third embodiment of the present invention；

Fig. 5 shows the 4th embodiment of the present invention.

Detailed description of the invention

In the following description, Primary Reference can be used as setting of GDD (Glaucoma Drainage equipment) Standby.But, this property of should not be considered as limiting, according to the present invention it is possible to imagine other of this equipment Drain is applied.

In fig. 1 it is shown that the schematic diagram of the first embodiment of this equipment.According to the present invention, it is former Reason is the hydrodynamic resistance of the disk regulation equipment by rotating, and the disk of this rotation passes through around fluid Variable section.Along with disk clockwise or counterclockwise, section expands or shrinks respectively, and resistance divides It is not decreased or increased.In order to reach this effect, this equipment includes inlet tube 1, its by fluid from eyes (or Other any parts needing drain) drain into hollow kiver 2.Container utilizes liner 4 hermetic seal, Liner 4 includes variable section opening 5, and fluid can be flowed to from the outlet 3 of pipe by variable section opening 5 Container, then flows to space outerpace by outlet opening 6.Although liner 4 hermetic seal container, but lining Pad 4 still is able to be rotated about their axes, and this axle is also the rotation axes of symmetry of container.According to the present invention, liner 4 Rotation change the opening 5 relative position relative to the outlet 3 of pipe, thus fluid flow is applied with Adjustable resistance.Open section when liner rotates (from the top) counterclockwise, before the outlet 3 of pipe Reduce, thereby increase flow resistance, otherwise, when turning clockwise, open big cross section and expand, convection current The resistance of body flowing reduces.

As be readily appreciated that, the principle of this system is simpler than the existing equipment above quoted to be obtained Many.

It is also required to provide the device being preferred for driving liner to rotate (preferably non-intrusion type).For Obtain tele-control system, in one embodiment, use the directivity external magnetic field applied.Real Recommended procedure and the device of existing this effect are as follows: liner includes the permanent magnet 7 producing magnetic field, and can pass through will External equipment (i.e. awareness apparatus) is seated in above the eyes of patient to be conveniently detected this magnetic field.Sense Know that equipment includes multiple sensor, such as magnetoresistive transducer or other can the equivalent apparatus in perception magnetic field. Can the information of in the future autobiography sensor combine with magnetic field equation, with amplitude and the direction in magnetic field of deriving.This permits Permitted accurately measure the direction of magnet 7 and thereby determine that the position of rotation of liner 4.

Once be aware of the direction of magnet 4, user can by apply strong external magnetic field and make liner by Given mode rotates, and orients this external magnetic field with the given angle relative to the actual angle of magnet 4.

Fig. 2 schematically shows the method.High-intensity magnetic field can add torque on magnet, this moment of torsion and magnetic The amplitude of field and the amassing of the magnetic moment of magnet 7 are directly proportional.Moment of torsion can make magnet 7 align with the magnetic field applied, Liner is thus made to rotate, the angle between the direction in the magnetic field that this rotation is equivalent to magnetic field and applying Difference.Utilizing the method, operator can make liner accurately and measurably rotate, therefore, in drain Equipment obtains the expectation of fluid resistance and changes.

Magnetoresistive transducer 9 is placed on wheel rim 8, and wheel rim 8 is positioned at the top of patient's eye.Sensor is used The direction of the magnet 7 below catching and calculating, on the screen of control unit 11, the direction quilt of magnet It is shown as the vector towards the left side.An angle, φ if the user desired that liner 4 is turned clockwise, he/her Rotating electromagnet 10, thus its direction forms the expected angle Φ between magnet angle, the direction is in control Illustrated by the vector towards the right on the screen of unit 11 processed.Then, user is energized for electromagnet 10, This is applied with the high-intensity magnetic field that polarity is contrary with magnet polarity, and the direction in this magnetic field and the vector towards the right Direction consistent.The magnetic field inducted applies strong moment of torsion to the magnet 7 of lower section, and this makes magnet 7 and towards the right side The vector alignment on limit, is achieved in desired liner and rotates.

In the design of another kind equivalent, the electromagnet 10 of rotation can be replaced by two fixing positive alternating currents Magnet.After being activated, the orthogonal electric magnet of the two each can produce the magnetic field along its axle, the direction. Total magnetic field is the vector of the two individual magnetic.Electric current relative of each electric magnet is led to by selection Intensity, it is possible to produce the magnetic field with any desired size and intensity.

Can measure the liner fluid resistance when different rotary position, thus, this selects to realize for user Rotational steps required for desired drainage effect and final IOP provides priori and instructs.In addition, User can apply increment to rotate and measure the IOP in each moment to verify the optimal location of liner 4.

Fig. 3 shows another embodiment of the invention.In this embodiment, ophthalmic it is inserted into empty Between and serve as the pipe 12 of fluid conduit systems and with right angle or be generally connected to container 13 with the oblique angle shown in Fig. 3.Hold Device 13 is flat with the base portion of eye contact or has the least spherical curvature part, the song of this sweep Rate radius is usually 11mm or approximation, and this radius of curvature is corresponding to the natural curvature radius of eyes.? Fig. 3 C shows this sweep.

In figure 3, " A " shows the assembled view of this embodiment of the present invention." B " shows this The decomposition view of equipment, illustrated therein is the inner panel 17 including variable section opening 16 and magnet 18.

" C " is the pipe-container assemblies cross sectional view along pipe 12 rip cutting, it is shown that the pipeline 14 that fluid flows through.

Fluid will flow out to container 13 by pipeline 14 drain and by outlet opening 15 and stacked opening 16 Inner chamber in, finally, fluid will flow out to space outerpace from this inner chamber by hole 20.As at the first In implementation pattern, the rotation of the plate 17 that the rotation of the magnet 18 by being caused by external magnetic field is brought, Thus realize the change of fluid resistance.Plate 17 assembles in the following manner: make it to the inner chamber of container 13 Bottom keeps certain pressure (such as passing through spring), thus in addition to by opening 16, not for stream Body flows out leaving space from pipe 12.Therefore, according to the principle of the present invention, opening 16 and outlet opening 15 Position relatively determines the effective dimensions of outlet opening, thus also determines effective fluid resistance of system.Excellent Selection of land, plate 17 has the axle (not shown) in the hole extending through container 13 to guarantee suitable relative rotation Turn.

In another kind of design illustrated in fig. 4, plate 17 can comprise multiple with variable section opening 16 phase To hole 21.The diameter in hole tapers into, and the most spaced apart relative to rotary shaft on circular arc: As disc rotary given angle Δ θ, hole 21 for a moment at top concentric with outlet opening 15.Here institute Anglec of rotation Δ θ between two the continuous print holes illustrated is 30 degree, but what this angle realized in expectation The change procedure of fluid resistance can change according to the quantity in hole and desired separating degree (fine setting).For Guaranteeing that the increment rotated is exactly angle delta θ, plate 17 can include allowing to rotate in its rotary shaft or its edge Stepping be exactly " gear class " system or the equivalent system of angle delta θ.Among others, this One example of system figure 4 illustrates.Dodecagon " gear " 22 is concentric with plate 17 and is attached to plate On 17.Hard but flexible beam 23 is fixed on the wall of container 13 and promotes 12 with power F determined One plane of limit shape " gear " 22.Any rotation less than Δ θ of plate 17 all can force beam the most curved Song, thereby increases contact force F.When the angle rotated is right up to Δ θ, contact force F returns to it Floor level.Such system ensure that two important functions:

1) it forces this system to occupy position at minimum energy point, thereby ensures that the angle of rotation exactly Δ θ or the multiple of Δ θ.

2) its prevent plate due to external mechanical factors (that is, the change of physiological movement, impact, external magnetic field, Etc.) and the accident that causes rotates.

It is obvious that the meaning that plate 17 causes due to the change (i.e. the change etc. in magnetic field of the earth) of external magnetic field External rotation or unexpected rotation can be by correctly changing the size in the magnetic field needing applying by electromagnet 10 Avoid, thus need the magnetic field applied to be more than spontaneous external magnetic field, and be enough to: a) overcome plate Frictional force between 17 and the bottom surface of container 13 and b) provide enough energy (moment) with bent beam 23 And carry out desired rotation.

Obviously, the similar system of continuous aperture also can replace the variable section opening 5 in Fig. 1.Additionally, " tooth Wheel " or be similar to other equivalent mechanical systems that the previously described accident limiting liner 4 rotates and also can wrap Include in the equipment described in Fig. 1.

In another embodiment, according to the equipment of the present invention can include along fluid passage 14 miniature Pressure transducer, it is the most as far as possible near ophthalmic space, and this micro pressure sensor is connected to can Remotely activating and the miniature telemetry system of energy supply, this system can send measurement to external receiver remote measurement IOP signal.This feature will allow simple and non-intrusion type ground measurement IOP.

The magnetic direction of the equipment that the principle of the present invention, i.e. perception are implanted also applies magnetic field with mobile or rotate The equipment of the described implantation of part, can be general for various armarium.One such example is Control the fluid flow in body conduit, body conduit such as vascular (vein or tremulous pulse) or other conduits (that is, urological catheters etc.).One example of the another embodiment of the invention illustrating this principle exists Shown in Fig. 5.

In this design, this equipment comprises the shell 24 being connected to clip 25 by hinge 26, this equipment Can arrange around vascular 27, thus vascular is comprised between clip 25 and flexible and/or elastic film 28 Space in, film 28 covers this equipment hermetically and prevents the interior arrangement of equipment and external fluid and group Any contact knitted.Clip 25 is by locking system 31 fix in position.As it was previously stated, comprise magnet 29 Elliptic Cylinder 30 can by apply external magnetic field rotate, thus, according to the rotation of Elliptic Cylinder 30 Indexing is put, its squeeze film 28 to some extent, therefore, compresses the transverse cross-sectional area of tremulous pulse to some extent. Then, this can cause hydrodynamic resistance change and control flow.It should be apparent to those skilled in the art that The shape of the Elliptic Cylinder 30 of clip 25 and rotation can be selected, so that rotating the vascular comprised Shape affect optimization, thus reach optimal result (that is, every degree of rotation, the cross-sectional area of vascular Territory is by linear change or changes a specified amount, etc..)

Additionally, this embodiment can be used for the equipment shown in Fig. 1, wherein, the vascular 27 of Fig. 5 is by entering Mouth pipe 1 substitutes to obtain identical regulating effect.

It is equally possible that utilize the system that is equal to the gear 22 in Fig. 4 and beam 23, with carry out to Determine rotation rather than the continuous print change of angle.

In another embodiment, the principle of the present invention can be applied to outlet opening 6 (seeing Fig. 1) Or 20 (seeing Fig. 3) limit and leave the flow of chamber 2 or 13.Utilize the principle of the present invention, can root According to the Angle Position of liner by cushion designs for opening one or more outlet opening, thus limit or increase and leave The flow of the fluid of container.Identical principle can be applied in the embodiment of Fig. 3, wherein, can beat Open one or more outlet opening 20 and leave the flow of container 13 with restriction or increase.

In another embodiment, as the replacement of the diameter to the section or hole changing opening, permissible Imagination utilizes the porous media with variable porosity battery rate.Such as, all of hole can have identical diameter also Be there is the sheath of different porosities or other biological biocompatible fabric is covered.Further possibility is wide Spend equal continuous opening, but with there is the sheath of graded porosity or fabric or surface of equal value covers opening. Such as, can carry out altered porosity by increasing the number of plies, thus when the number of plies used increases, porosity subtracts Little.

In one deforms, even if adding these porous medias, opening or hole also variable-size.This Can allow preferably to regulate flow.

Certainly, above-mentioned embodiment is nonrestrictive illustration, and the deformation of use equivalent arrangements is Possible.

Claims (6)

1. an implantable devices for adjustable drainage, at least includes the inlet tube of the passage as drain fluids (1；12), described pipe (1；12) chamber (2 it is connected to；13；24), wherein said chamber (2；13；24) include using Rotary apparatus (4,5 in the flow velocity regulated in described pipe；16,17；30), wherein, described chamber (2) at least has The fluid having the import (3) being connected with pipe and at least one permission drain leaves the outlet (6) of chamber, described rotation Rotary device be characterized by including the opening (5 of a continuous variable shape；16；21) element (4；17), To provide the resistance of continuous variable along Opening length fluid flow, thus by this opening relative to this The position of import, above or exports on (6) at least one, by this element relative to this chamber in this import (3) Relatively rotation place fluid flow apply continuous variable resistance.

2. equipment as claimed in claim 1, it is characterised in that described opening be have variable section or There is the opening (5 of the different porous media of porosity；16).

3. equipment as claimed in claim 1, it is characterised in that this equipment also includes for realizing rotation Device (4；17；30) attachment device (22,23) that stepping rotates.

4. equipment as claimed in claim 3, it is characterised in that described in be used for realizing rotary apparatus (4；17；30) The attachment device that rotates of stepping include the gear-like system (22) that coordinates with bendable curved beam (23).

5. equipment as claimed in claim 1, it is characterised in that described rotary apparatus (4；17；30) include For detecting and regulate described rotary apparatus (4；17；30) permanent magnet (7 of position of rotation；18；29).

6. a system for the flow velocity of regulation equipment according to any one of aforementioned claim 1-5, wherein Described system includes positioner (10) and for determining the detector (9) of the position of described rotary apparatus, This positioner (10) for being positioned at predetermined rotational positions with regulation drainage device by described rotary apparatus Flow velocity, wherein, described detector includes on wheel rim mounted externally for detecting permanent magnet (7；18；29) position The magnetoresistive transducer (9) put and be used for the described permanent magnet (7 that aligns as positioner；18；29) electromagnet (10)。