CN104168943B - Tubulose clip is utilized to reduce the intraocular pressure in eyes - Google Patents

Abstract

Can be so that aqueous humor to be discharged from the anterior chamber of eyes by ductility hollow clip or bail, this clip or bail can be formed as the intracavity flowing being attached to ophthalmology tissue and providing aqueous humor to pass through clip.Additionally, on the basis of during initial surgical operation and after surgery, clip can be adjusted, to regulate the outflow of aqueous humor.Additionally, describe a kind of apparatus, during wherein the tweezers of clip delivery apparatus reside in the chamber of hollow clip during configuration and manipulation.The feature of apparatus is designed in order to clip to be fixed to delivery tweezers, and prevents the tissue occlusion in the chamber of clip.The color of clip can be with the Organization Matching of lower section to pretend, and the surface of clip can be with drug delivery.

Description

Tubulose clip is utilized to reduce the intraocular pressure in eyes

The cross reference of related application

The interests of the U.S. Provisional Application No.61/598,208 of patent application claims submission on February 13rd, 2012；This Shen Entire disclosure please is incorporated by reference in its entirety herein.

The theme of the application relates to the master of U.S.'s non-provisional application No.13/709,375 of December in 2012 submission on the 10th Topic；The entire disclosure of this application is incorporated by reference in its entirety herein.

Technical field

Present invention relates generally to ophthalmic surgery.Exemplary embodiment relates to by discharging room from the anterior chamber of eyes Water and treat the embodiment of glaucoma and other disease.

Background technology

Glaucoma is blind one of the main reasons.It causes owing to intraocular pressure (IOP) increases, and this may damage Optic nerve.The source that pressure increases is the generation of aqueous humor and the imbalance of discharge.Before aqueous humor (aqueous humor) is filling eyes Portion (anterior chamber) the transparent fluid produced by continued eye.Aqueous humor is carried out by ocular region in the region of referred to as angle of anterior chamber Discharge.In normal eyes, drainage rates is extremely mated with producing speed, thus keeps the healthy pressure in eyes.Work as room When the discharge of water is hindered, IOP increases.

For surgical operation therapy glaucoma, the traditional surgery of such as trabeculectomy removes the group in angle of anterior chamber Knitting, this forms opening, in order to aqueous humor is discharged, and thus reduces IOP.Then, surgeon forms sclera at angle overthe openings Lobe tissue, to allow fluid from scleral flap discharge, and is drained in the memory space between conjunctivae and selerae.This aqueous humor is deposited Storage is referred to as blister.One of traditional trabeculectomy problematically, the opening that produces at this angle may become blocking or May close, this reduces or eliminates its effect.In order to process this defect, there is drainage arrangement, to provide more measurable And lasting aqueous humor discharge.The present invention is provided to novel method and device that quick, simple and lasting aqueous humor is discharged Exemplary embodiment with system.

Summary of the invention

Present invention generally provides the medical treatment device of improvement, system and/or method.Embodiments of the invention are particularly suitable for Ophthalmic surgery, including novel method and device, in order to discharge aqueous humor from the anterior chamber of eyes.One illustrative methods includes Using ductility hollow clip or bail, it can be configured such that to be attached to ophthalmology tissue, and provides by this clip Aqueous humor intracavity flowing.Additionally, in some cases, during initial surgical operation and after surgery on the basis of, clip can To be optionally adjusted, to regulate the outflow of aqueous humor.Additionally, describe a kind of apparatus, the wherein arm of tweezers or clip Other structure of delivery apparatus resides in the drain chamber of hollow clip removedly.The feature of this apparatus is designed in order to incite somebody to action Clip is fixed to delivery apparatus, clip is evenly installed to tissue, and prevents the tissue occlusion in the chamber of clip.The table of clip The color in face can be with the Organization Matching of lower section to pretend, and/or the surface of clip can be with drug delivery.

In an aspect, the method that the present invention is provided to discharge excess fluid from the region of patient body, this region Defined by tissue.The method includes penetrating tissue, in order to make the elongated leg of draining clip be distally advanced in tissue.Tissue Engage with the base portion of draining clip, and at least some of deformation of the leg of the draining clip advanced so that base portion and leg Draining clip is attached to tissue.Excess fluid can be transmitted along the passage of leg from this region.

In one aspect of the method, the present invention is provided to discharge the system of excess fluid, this district from the region of patient body Territory is defined by tissue.This system includes the draining clip with elongated leg, before this elongated leg is distad configured for Enter in tissue.Leg has the passage extended along it, and draining clip also includes that the proximal end with leg is adjacent to The base portion arranged.Base portion can be orientated to engage tissue, in order to when clip has progressed to desired depth optionally Help halts.Advance draining clip leg be configured at least partially deformation so that base portion and leg Draining clip is attached to tissue, and excess fluid is transmitted from this region along the passage of leg.

In certain embodiments, this region carrying out the health of draining can be included the patient's eye of certain volume.Should Tissue can include that eye tissue, fluids along channels transmission can aid in the excessive intraocular pressure (IOP) alleviating eyes, bag Include the IOP relevant with glaucoma.The internal diameter of the passage of leg can be optionally about 0.002 "-0.008 ", the external diameter of leg About 0.005 "-0.013 " can be optionally.In certain embodiments, passage can have material (or permissible in passage Receiving has material), this material contributes to providing desired flow.Can provide quantity optional leg, with provide relevant can The flow of choosing.

Leg is typically included tubular body, and this tubular body has proximal open and distal openings, this proximal open and There is chamber, for use as passage between distal openings.The configuration that leg can be configured to by being arranged in chamber is the most remote Advance in side, in order to suppression tissue enters in chamber.This axle can be regained by proximad from chamber, in order to fluid passes along chamber Pass.Optionally, axle can be included in configuration component, and this configuration component supports this clip releasedly when penetrating tissue. In certain embodiments, configuration component can be included in the distal extension of draining clip so that penetrating the sharp distal end of tissue Portion, this sharp distal end can be optionally disposed on the axle in chamber, and configuration component can be included in lateral leg and side is prolonged The body stretched or axle, etc..Some embodiments of configuration component can include the actuatable axle extended along leg, and leg Deformation can cause outside tissue by activating this actuatable axle so that axle causes the distally foot of leg the most curved Song, to be captured in tissue between foot and base portion.Actuatable axle can be included in leg and extend distally into deformation mechanism And/or the wire rod of body or axle, the proximal movement of its axis laterally promotes deformation mechanism and/or body against foot, in order to Make foot deformities.In certain embodiments, deformation mechanism and/or body can be provided in the structure in leg.Real at other Executing in example, deformation mechanism can be incorporated in foot so that the load from axle is applied on foot and causes the curved of foot Bent.When deforming body and being included in configuration component, deformation body can be constructed such that when configuration component is regained from patient Time deformation body is proximally pulled through draining clip can stretch deformation body and draining clip is stayed in tissue.

In many examples, multiple legs of drainage clip subsystem proceed in tissue.Optionally, base portion is permissible Cross between the first and second legs of single clip.In other embodiments, what base portion can include from tubulose leg is near The tubular material that side end extends, wherein base portion is by separately managing partly and the most outwards being opened by each several part of pipe Open and formed.

Accompanying drawing explanation

Fig. 1 show below scleral flap use clip so that aqueous humor discharge illustrative methods.

Fig. 2 shows the exemplary embodiment of equipment, and wherein clip is made up of single pipe.

Fig. 3 shows the exemplary embodiment delivering tweezers equipment of carrying hollow clip.

Fig. 4 shows being implanted by tissue of being formed so that the exemplary embodiment of clip of aqueous humor draining.

Fig. 5 shows the exemplary embodiment of the equipment for hollow clip, and it can be used in the scalable flowing of aqueous humor.

Fig. 6 schematically shows shank and the proximal end of the axle of the configuration embodiment for clip as herein described.

Fig. 7 A1-7A3 (collectively referenced as " Fig. 7 A ") shows the draining having by crossing over 2 legs that connector connects Clip is in the embodiment of its first configuration phase, and it pierces through supporting mechanism and collocation mechanism pierces through organized layer so that this leap Part is concordant with tissue.

Fig. 7 B1-7B3 shows the embodiment identical with Fig. 7 A, and it is in when piercing through supporting mechanism from tissue withdrawal Time the second configuration phase.

Fig. 7 C1-7C3 shows the embodiment identical with Fig. 7 A, and it is in when collocation mechanism makes the end of each leg curved 3rd configuration phase of the bent drainage clip period of the day from 11 p.m. to 1 a.m to form Guan Bi.

Fig. 7 D1-7D3 shows the embodiment identical with Fig. 7 A, and it is in the 4th when activating wire rod and regaining from tissue Configuration phase.

Fig. 7 E1-7E3 shows the embodiment identical with Fig. 7 A, and it is in when the remainder of collocation mechanism is received from tissue The 5th and final configuration phase when returning.

Fig. 8 A1-8A4 shows that having the draining clip of at least one leg is in the embodiment of the first configuration phase, should One end of leg terminates at ' T ' opened, and it pierces through collocation mechanism and pierces through organized layer so that ' T ' opened is concordant with tissue.

Fig. 8 B1-8A4 shows the embodiment identical with Fig. 8 A, its be in be pulled when actuation connection so that The other end of leg has opened for ' T ' so that the second configuration phase when itself and tissue are concordant.

Fig. 8 C1-8C4 shows the embodiment identical with Fig. 8 A, its be in be released when actuation connection so that Actuating mechanism can pass through the 3rd configuration phase when being retracted in the middle of draining clip.

Fig. 9 A1-9A3 shows that having the draining clip of at least one leg is in the embodiment of the first configuration phase, should One end of leg terminates at opens, and it pierces through configuration actuator and pierces through organized layer so that ' T ' opened is concordant with tissue.

Fig. 9 B1-9B3 shows the embodiment identical with Fig. 9 A, its be in when pierce through configuration actuator be pulled with The other end making leg has opened for the second configuration phase during triangle concordant with tissue.

Fig. 9 C1-9C3 shows the embodiment identical with Fig. 9 A, its be in when pierce through configuration actuator passed through clip The 3rd configuration phase when being retracted.

Detailed description of the invention

There is provided for discharging aqueous humor and the method and apparatus reducing IOP.Fig. 1 shows use hollow ductility clip 2 Or the illustrative methods of bail, this clip or bail can be attached in the organized layer of such as sclera S, and provide a mean for The path of this tissue draining.One or two leg 4 of clip is hollow, and perform be attached to tissue (when be formed as by During a pair compatible tweezers Guan Bi) and allow the dual-use function that fluid flows at intracavity.Fig. 1 show placement clip so that Carrying out an illustrative methods of trabeculectomy, wherein, this clip is formed from pre-inserted structure or bends to closed structure, and Thus it is attached to organized layer, thus this clip provides aqueous humor from the anterior chamber of eyes to the discharge of scleral flap F lower zone.Lobe F can To be attached to the over top of the clip of configuration outside cornea C, as skilled in the art will understand.

Fig. 2 shows the exemplary embodiment of clip device 6, and this clip device can be by any biocompatible ductility The pipe that material is formed is made, and this material is such as tantalum, rustless steel, titanium and/or plastics.More specifically, it is provided that desired length Tube material 8, wherein regional area utilizes any amount of method of such as machining, laser energy or chemical etching to carry out Excise, cut or cut.Utilize such method, in pipe, feature structure can be cut out in the position of any desired quantity, So as to flow in and out of fluid.In this shown specific embodiment, a part 10 for pipe is cut flows out district to provide Territory, tube end 12 is used for flowing into, and wherein cut-out is formed selectively the base portion between two tubulose legs of clip, and And the chamber of leg is easy to fluid and discharged by tissue, clip will configure in this tissue.

Fig. 3 schematically shows the exemplary embodiment of clip configuration system 14, including being installed to tweezers equipment 16 Clip 2, this tweezers equipment can be used in being placed by clip and fixing in the tissue.In this embodiment, the tubular legs of clip 2 Portion 18 is each carried on the end of tweezers 16 so that the end of tweezers jaw 20 just extends beyond the end of clip leg Portion.Tweezers end 20 can be sharp-pointed, in order to penetrates sclera S.This equipment provides multiple clinical advantages.First, at clip In the case of tubulose leg is loaded directly on tweezers, clip is kept regularly (such as by spring-loaded protuberance 22) so that it can be prevented from departing from unintentionally tweezers.It is being fixed on additionally, clip is carried in by this way on tweezers In tissue, period provides the good control of clip deformation.Second clinical advantages of illustrated embodiment is, sharp-pointed tweezers end End penetrates tissue and blocks the chamber of hollow clip, enters undesirably to prevent from organizing, and the entrance of tissue may block or with it Its mode weakens the draining by clip.

In the operation of the embodiment shown in Fig. 3, shank provides the axially-movable of outer shaft 26.When shank promotes forward outer shaft Time, it compresses tweezers jaw and thus closes attached ductility clip, thus being fixed in the tissue by clip.On tweezers Feature is shown as during inserting tissue at tweezers and clip preventing clip from sliding backward.These physics resistance on tweezers jaw Gear additionally aids the front clip in jaw Guan Bi and evenly installs against tissue surface.Illustrate in this embodiment is extra special Levying is spring-loaded protuberance 22, and it can provide dual-use function: physical barriers, to prevent clip from sliding forward from tweezers jaw Fall；And as anvil block, during being formed when jaw closes, this anvil block contributes to the shaping of clip.When configuration completes, in order to Being discharged from jaw by clip, spring-loaded protuberance can be removed by the action of shank.

Fig. 4 shows the exemplary embodiment of the clip 2 of Guan Bi, and wherein clip is formed as triangle by tweezers jaw Shape, clip is fixed in tissue ' T ' by this triangle, and resists further motion.But, the leg end of hollow clip Remain exposed at fluid, carry out discharging stream by tissue ' T ' from high-pressure area 28 to the expectation of area of low pressure 30 for fluid Dynamic.On the distal end opposite side side with suspension of organized layer, at the proximal end of clip leg, fluid flows out, wherein Clip has been cut to form base portion 32 and has allowed such draining.In other embodiments, proximally end can be allowed Flowing towards distal end.

There may be expectation after inserting and/or implanting and remove or reorientate the situation of clip.This can utilize use The identical tweezers configuring clip perform, or the special tweezers that can optimize with removing for clip perform.Tweezer Sub-jaw can obtain the chamber of clip leg in the way of similar with Fig. 3 again so that tweezers jaw slides into hollow clip legs In portion.Extension characteristics due to clamp material so that tweezers jaw can activated and move out, thus opens clip legs Portion, to be generally oriented to be easy to the withdrawal of clip with organizing vertical.In this, clip can be removed or in another position Reconfigure in putting.

The present invention includes the method for the regulating flow quantity by the fluid of clip.Optionally, this is by changing The geometry flowing in or out aperture and/or size on clip and realize.This can utilize the extension spy of clamp material Property pinch chamber or otherwise change the shape of clip and realize to change the cross-sectional area in clip aperture.As other one Planting and select, insert can be placed in chamber and/or from chamber and remove.Additionally, during initial surgical operation or after surgery On the basis of can carry out the regulation to clip flow, in order to regulated fluid stream in the case of need not to remove clip.

Fig. 5 shows the exemplary embodiment of the clip device that can regulate drainage rates.This embodiment is similar to Fig. 1-4 Shown embodiment.But, in this embodiment, an arm of clip has leg 36, and this leg has atrium 38, and Another leg 40 of clip is Guan Bi and is rounding.In order to change the effective vent cross section in the chamber 38 being exposed to fluid Long-pending (thus regulating flow), leg is promoted toward each other so that the Guan Bi of a clip leg and the end of rounding can portions Divide ground or the chamber fully against open end, and/or leg is promoted away from each other to increase flow.The clip of Guan Bi end The degree of closeness of the clip leg of leg next-door neighbour's atrium increases or reduces the exposed surface area of atrium and regulate circulation.

In the method relevant to clip Flow-rate adjustment, it is used for configuring the shank of clip and tweezers can be calibrated, to incite somebody to action Clip port size and/or flow pass to operator.The given position of shank provides the position of tweezers jaw, thus provides The relative forming position of clip.In the embodiment shown in fig. 5, such as, shank can be calibrated to indicate clip leg (with And thus port size) relative proximity.Therefore, for the given position of shank, the size in clip aperture can be known, And it is calibrated to handle position.Therefore, it can on shank, mark suitable labelling, to indicate port size and/or clip Flow.This can during initial surgical operation or after surgery on the basis of carry out, meet patient to regulate clip flow Need.

With reference now to Fig. 6, at least Fig. 7 A-7E (and other embodiments the most as herein described) draining clip and The exemplary embodiment of relevant configuration device can include shank 60, and this shank is connected to configure the proximal end of shaft assembly 62 Portion, in order to support the clip configuration structure being positioned adjacent to the distal end of configuration component and optionally make this clip join Put structure and carry out pivotal motion.More specifically, configuration system can include shank 60, this shank has optionally support and pierces through The shank body 64 of shaft actuator mechanism 66, pierces through shaft actuator mechanism and is piercing through this thorn while supporting mechanism pierces through tissue Perforating branches support mechanism releasably holds in place, and can activate near shank, with from tissue withdrawal pierce through supporting mechanism or Axle.It addition, shank 60 includes the deformed shaft actuator mechanism 68 supported by shank body 64, this deformed shaft actuator mechanism allows Operator is such as by pulling so that clip deforms and makes deformation mechanism carry out pivotal motion at actuating wire rod or actuator shaft.One In a little embodiments, the additional actuated of deformation mechanism (or another structure) can be the most logical so that clip is from configuration system release Cross and further pull on action wire rod or axle, until they depart from distally collocation mechanisms remainder and can be from draining clip Freely regain.Being attached to the clip support structure 69 of shank body 64 (and can by clip at least some of period of configuration The optionally extra parts of distally collocation mechanism) it is held in place relative to shank body, and also can (such as) row of preventing Water clip moves relative to collocation mechanism (and/or other configuration structure), until collocation mechanism is the most fully actuated and activates Wire rod has been retracted.

With reference now to Fig. 7 A-7C, illustrate in greater detail the distal part of configuration component 62.Clip 70 supports releasedly Near the distal end of configuration component 62, and configuration component can help to insert the clip in tissue ' T ' and permissible Help configuration clip so that clip is attached to this tissue and configuration component can be retracted.Pierce through for a pair of configuration component 62 Support member 72 has slightly pointed distal end, and this distal end contributes to piercing through tissue T, generally makes tissue can be attached to clip And/or tissue can be kept by clip.Pierce through the rigid structure that support member 72 can include having passage, this rigid structure Support and during this pierces through action, avoid contact tissue with relaying configuration mechanism and clip.Activate wire rod 74 a pair to be attached to join Put body or mechanism 76, and be configured to so that configuration ontology or mechanism 76 are mobile when pulled at configuration wire rod and/ Or deformation.Then, activate wire rod 74 along nearside relative to configuration ontology or mechanism 76 further pull on or nearside moves permissible Wire rod is separated with collocation mechanism (via the frangible welding between wire rod and foot, bonding or other removably connect, via By partial cut-out or otherwise weaken wire rod and the frangible distal part of wire rod that formed, etc.).Thus, work as configuration When mechanism has made the leg curvature of clip, wire rod can be regained from clip and tissue.

The structure of clip 70 and deformation can be as shown in Fig. 7 C and 7E.Clip 70 generally comprises the first and second tubulose legs 73, it is extended with body 75 between them.Leg 73 is deformable at least partially so that each leg the most removable Part or foot 77 move relative to body 75, in order to attach the clamp to tissue T.Notice, in certain embodiments, can move Dynamic part or foot 77 can contain largely or entirely leg.It is also noted that leg can plastically and/or flexibly become Shape, and body may or may not be tubulose, as from multiple embodiments as herein described it will be appreciated that.

It is referred to Fig. 7 C and 7D and understands the deformation of clip 70 and removing of wire rod 74.In order to configure clip, collocation mechanism 76 are configured to deform in multiple positions under the column load and/or bending load of wire rod 74 applying, in order to make drainage clip The leg 73 of son 70 bends.Exemplary draining clip 70 has by crossing over part or two hollow legs 73 of base portion 75 connection, And the part near two ends of two legs has narrowed or pressure alleviates so that they can be than its remaining part of leg Divide and be more prone to bending.Two ends of one or two leg can be with the optionally provided chamber to leg or hollow centre Directly touch.Once configuring, this most optionally allows fluid to pass one or two leg, to alleviate overvoltage or the like. Leg inner chamber can also allow for activating wire rod and passes.By pulling the actuating of collocation mechanism 76 that wire rod 74 causes initially to make configuration Mechanism or body 76 move, and this body bends, deforms and make the foot 77 of each leg 73 to move relative to the base portion of clip Dynamic.Then, further activate and wire rod is separated with configuration ontology, separate with the distal end of configuration component, and also permissible Wire rod is pulled from clip.

Can be clear that in figure 7e and remove, at configuration component, the clip configured afterwards, wherein clip and being organized in Shown in the cross-sectional view of Fig. 7 E1, the distal part (with distal tissue surface) of the leg of configuration shown in Fig. 7 E2, and Clip body 75 and proximal tissue surface are shown in Fig. 7 E3.Clip in the embodiment of Fig. 7 can be configured to allow for the eye-chamber Water is discharged by other tissue (referred to as tissue or material) of scleral tissue and/or eyes, and leg 73 pierces through and trap these groups Knit.Alternative embodiment can allow other fluid to be discharged by any material that may be penetrated by leg 73, trap, by This allows structure or hollow body to be discharged.In this embodiment, clip can be oriented such that shank is in outside eyes In portion, and the configuration side of the leg 73 of clip 70 or distal end are in the anterior chamber of eyes.This embodiment and/or other Embodiment can also be used to subjacent tissue's plane or layer, adjacent tilt or against organization edge and/or plane, and/or adjacent Connect more than 2 tissues, or can be used merely to strengthen monolithic tissue.In addition to tissue, clip can also be used to adjoin it Its material, or their any combination.Although this example show a pair leg connected by single leap part, but identical Concept may be used for by zero or more cross over that part connects with the most linear or matrix pattern one or Multiple legs.Thus, by configuring the clip of desired amt and/or array, the overall draining characteristics by tissue can be selected. Actuating mechanism and shank assembly can also carry more than one draining clip in box or clip.Activate and shank assembly is permissible More than one position configures more than one draining clip simultaneously.The end of clip can be divided into multiple toe, these Toe can be folded along one or more directions by actuating mechanism.

The embodiment of all devices focusing on ophthalmic applications as shown in Figure 7 can be the least, optionally has Clip leg chamber ID is of about .002 "-.008 ", and leg OD is of about .005 "-.013 ", and the device span between leg is less than 0.3 " (the most about .080 "), and/or penetration depth is less than 0.2 " (the most about .040 ").Other application can be adopted With having various sizes of clip and device.Noticing, some or all leg of clip can partially or even wholly block , thromboembolism or solid (such as utilizing other collocation mechanism), and this can be different for each leg.Though So this embodiment for ophthalmic applications and thus its clip can by deformable and biocompatible material (such as rustless steel, Titanium, tantalum, platinum and/or gold) make, but this or other application can use other clamp material widely.

Can include from following steps for configuring the method for the embodiment (and other related embodiment multiple) of Fig. 7 One or more elements:

1.The distal end of configuration component and clip is distad pressed against tissue to be fixed or the surface of other material, directly Be pierced supporting mechanism the most completely to this material to penetrate, and the body of clip or cross over part concordant with this material, such as Fig. 7 A Shown in.

2.In the case of clip is concordant with this material, activate this device pierces through shaft actuator 66, and it is received from this material Return and pierce through supporting mechanism, as shown in Figure 7 B.

3.In the case of clip is still concordant with this material, activate deformed shaft actuator 68, in order to proximad pulls wire Material 74, and make collocation mechanism or foot 76 carry out pivotal motion, so that the end bending of each leg 73, this is this device In second action, as seen in figure 7 c.

4.While utilizing this device to keep the pressure to clip, activating the 3rd action in this device, this action will Activate wire rod 74 to regain from clip proximad, as illustrated in fig. 7d.

5.Configuration component is pulled away from this material, and this will stretch collocation mechanism or foot 76 and pull it clip legs The chamber in portion 73 and material or tissue T, and clip is stayed in the material, as seen in figure 7e.

With reference now to Fig. 8 A1-8C4, it is shown that another exemplary embodiment of draining clip 80, it has delivery system Adjacent component, but not tissue in Fig. 8 A1 (before configuration) and Fig. 8 B1 (during configuring), and in Fig. 8 C1 Clip after showing the configuration of configuration system and removing.It is referred to Fig. 8 A2-8A4；8B2-8B4 and 8C2-8C4 understands clip Interaction between 80 and tissue ' T '.

Draining clip 80 generally comprises the tubulose leg 82 with proximal base 84, and wherein a part for leg includes foot Portion 86, this foot can move relative to base portion, to attach the clamp in tissue T.Leg 82 generally includes chamber 81, to provide By the draining in this chamber, and the relevant configuration device of Fig. 8 A-8C includes shank 60 (seeing Fig. 6), has in shank 68 Deformation actuating mechanism.This allows operator's proximad on the axle of actuation connection to pull, until tissue pierces through axle 85 Tissue penetrating distal end proximal motion, thus axle makes distally collocation mechanism 83 stretch, this is then by the end of leg 83 Or foot 86 opens for " T ".In actuating so that after foot deformities, deforming actuator can be configured to allow the company of actuating Fitting distad returns in its position being pre-configured with.The distal movement of axle 85 allows actuating mechanism 83 to return to its less horizontal stroke Cross section be pre-configured with shape, to allow the chamber proximad of axle and the collocation mechanism leg by configuring to regain.It is attached to shank The clip support structure 69 of (seeing Fig. 6) keeps the remainder of collocation mechanism relative to shank, and prevents draining clip edge Collocation mechanism to move towards shank, until collocation mechanism is regained from clip.

In this embodiment, pierce through shaft actuator and can omit and/or be attached in deforming actuator, and the company of actuating The axle 85 of fitting has slightly pointed end to pierce through tissue and to make collocation mechanism deform when pulled.Collocation mechanism 83 is at axle Carry out pivotal motion at multiple desired locations, bend and/or deform under 85 column loads applied, in order to make the leg of draining clip 82 (and in particular foots 86) bend desired deformation, and this collocation mechanism is further configured to when being pulled through draining clip Its little contour shape being pre-configured with of Shi Chaoxiang is retracted.Draining clip 80 can include single hollow legs, two ends of leg The pressure in portion alleviates so that they can bend more easily than the remainder of leg, and an end of described leg ' T ' shape is generally prebended in portion's (typically proximal end), and two ends of leg provide chamber 81 or the hollow of described leg Directly touching of center, passes during configuring for actuating mechanism, and passes after configuring for fluid.

In this embodiment, clip can be configured to allow aqueous humor (it penetrates and catches by scleral tissue Collect this scleral tissue), discharged by any material that may be pierced, trap and discharge.In this embodiment, clip can To be oriented such that shank is on the outside of eyes, and the configuration side of clip proceeds to the tissue of eyes from the anterior chamber of eyes In, including the tissue of the fluid outflow path along eyes.Such as, as shown in Fig. 8 A2-8A4, intra-operative within the eye, clip 80 and the relevant distal end of configuration component can be distally advanced in the tissue surface TS of the fluid being exposed to eyes anterior chamber. The eye tissue that the sharp tips of axle 85 and foot 86 can advance through near canthus (is formed by iris and cornea, such as Fig. 1 institute Show), and/or proceed to nature or artificial fluid outflow path passage FC or advance from this passage so that foot can be at this angle In degree or passage or only deform, and the open end attachment of clip leg is exposed to passage and anterior chamber, to provide fluid stream Dynamic.

Although this embodiment is shown without subjacent tissue's plane, but same (or similar) embodiment can be effectively For adjoining oblique organization edge and/or tissue plane, and the tissue of more than two can be adjoined, or can be used merely to Strengthen monolithic tissue.In addition to tissue, clip can also be used to other material adjacent, or their any combination.Although should Embodiment shows that single leg is not connected to extra leg by any leap part, but identical concept may be used for leading to Cross multiple legs that one or more leap part connects with the most linear or matrix pattern.Actuating mechanism and shank group Part can also carry more than one draining clip in box or clip.Activate and shank assembly can be in more than one position Upper configure more than one draining clip simultaneously.One end of clip or each end can be divided into only one, two, three Individual or the toe of more than three or foot, these toes or foot can be folded on nearside or the shank side of clip in advance, and And can be folded on distally or the far-end of clip along one or more directions by actuating mechanism.The exemplary embodiment of device (thus clip leg ID can be in the range of about .002 "-.008 ", and leg OD can be about to focus on ophthalmic applications "-.013 ", and the axial length near foot of leg can optionally be configured to penetration depth (very outline .005 Ground) it is of about .040 "), other application can use has various sizes of clip and device.Notice, clip some or That whole legs can partially or even wholly block, thromboembolism, or in the case of using other collocation mechanism can be Solid, and this can be different for each clip used in clip systems.Although this embodiment is used for eye Section's application and its clip can be made up of deformable and biocompatible material (such as rustless steel, titanium, tantalum, platinum or gold), But this or other application can use other clamp material.

The method of embodiment using Fig. 8 A-C can optionally stand the one or more steps in following steps:

1.Device assembly is distad pressed against material surface to be fixed, until this material is pierced configuration machine the most completely Structure penetrates, and clip is concordant with this material, as shown in Fig. 8 A2-8A4 with ' T ' that open in advance of nearside.

2.In the case of the nearside ' T ' opened in advance of the nearside of clip is concordant with this material, activate this device so that Pierce through collocation mechanism and open another distal end of clip, as shown in Figure 8 B.

3.No longer actuation configuration device, and it is pulled away from this material and clip.This will stretch and pierce through collocation mechanism And pull it clip, and clip is stayed in the material, as shown in Figure 8 C.

With reference now to Fig. 9 A1-9C3, another exemplary embodiment of draining clip 90 includes having in proximal end Empty leg, this proximal end has base portion 92, and this base portion is the form of similar to the above " T " that open in advance.It not to move The collocation mechanism removed makes the foot deformities of leg, but foot has the knot that can activated and keep together with the clip of configuration Structure.More specifically, draining clip 90 is included in the configuration system with shank (seeing Fig. 6), this shank includes actuating mechanism, This actuating mechanism allows operator to pull on configuration actuator shaft piercing through, until axle configures foot 96 completely, rear axle Depart from from the foot 96 of configuration or the end of draining clip 90, and be retracted by clip.The axle being such as attached with shank Supporting construction (not shown) draining clip 90 can be kept to fix relative to shank, until piercing through configuration actuator 94 by folder Son and be retracted.Pierce through configuration actuator 94 when pulled, the foot 96 of draining clip 90 is deformed, more specifically from The leg of clip is laterally extending, in order to attach the clamp to tissue T.

Draining clip 90 can be formed by single hollow pipe, the proximal end local weakness of this hollow pipe or ease off the pressure, So that it can bend to ' T ' shape more easily than remainder.Another end or distal end can with local weakness, with Just deform in multiple positions under the column load that actuator 94 applies, thus obtain triangular shaped, the base portion of this triangle Become concordant with tissue.Two ends of leg can provide directly touching of the hollow centre of described leg again, for Draining and/or be used for is pierced through configuration actuator and is passed.

Clip 90 and similar embodiment can be designed that aqueous humor passes through scleral tissue's (referred to as tissue or material) (it penetrates and traps this scleral tissue), discharged by any material that may be pierced, trap and discharge.In this and phase In the embodiment closed, clip 90 can be oriented such that shank is on the outside of eyes, and the configuration side of clip is in eye In the anterior chamber of eyeball.Although this embodiment is shown without subjacent tissue's plane, but same (and/or similar) embodiment is permissible Effectively for adjoining oblique organization edge and/or tissue plane, and the tissue of more than two can be adjoined, or can be only Only it is used for strengthening monolithic tissue.In addition to tissue, clip can also be used to other material adjacent, or their any combination. Although this example show single leg not to be connected to extra leg by any leap part, but identical concept being permissible For the multiple legs connected with the most linear or matrix pattern by one or more leap parts.Actuating mechanism and Shank assembly can also carry more than one draining clip in box or clip.Activate and shank assembly can be more than one Position on configure more than one draining clip simultaneously.One end of clip or each end can be divided into only one, Two, three or the toe of more than three, these toes will be folded on the shank side of clip in advance, and can be at clip Polygon cone is become along one or more Direction distortions on distally.

Although clip 90 be very suitable for ophthalmic applications (optionally, clip ID be .002 "-.008 ", OD be .005 "- .013 ", and/or leg is configured to penetration depth and is less than .3, the most about .040 "), but other application can use tool There are various sizes of clip and device.Notice, some or all leg of clip can partially or even wholly block, bolt Plug, or can be solid in the case of using other collocation mechanism, and this can be for each leg Different.Although this embodiment is for ophthalmic applications and thus its clip can be by deformable and biocompatible material (such as rustless steel, titanium, tantalum, platinum or gold) is made, but this or other application can use other clamp material.

Use clip 90 method can optionally comprise the following steps in one or more steps:

1.Device assembly is distad pressed against material surface to be fixed, until this material is pierced configuration the most completely and causes The leg of dynamic device and clip penetrates so that ' T ' or other base portion that open are concordant with this material, as shown in Figure 9 A.

2.In the case of ' T ' that open of clip is concordant with this material, activate this device so that pierce through configuration actuator Open another distal end of clip, as shown in Figure 9 B.

3.Continue pierce through configuration actuator on pull so that actuator shaft is pulled through clip, and is stayed by clip In material, as shown in Figure 9 C.

For each method and apparatus as herein described, clip can be combined with surface modified, to obtain further Clinical benefit.A kind of possible surface modified is at least some of (such as with the exposure of eyes on the surface of clip The part that front surface is adjacent) on increase color, this by allow clip for aesthetic purpose the surrounding tissue that disguises oneself as.Such as, Clip can be made for white, in order to mixes with scleral tissue.Another possible surface modified can be to add medicine, with Meet various clinical needs.

Embodiment as herein described is exemplary.When referenced in schematic describes these embodiments, for art technology For personnel, described method and/or the various amendments of concrete structure or change can be obvious.

In the foregoing, the specific embodiment of the reference present invention describes the present invention, but those skilled in the art will It will be recognized that the present invention is not limited to these embodiments.The various features of foregoing invention and aspect can be individually or in combination Use.It addition, without departing from description define spirit and scope in the case of, the present invention may be used for beyond as herein described Any amount of environment and application.Therefore, specification and drawings should be considered to be exemplary and not restrictive.To recognize Knowledge is arrived, and term as used herein " includes ", " comprising " and " having " specifically will pronounce the open term of this area.

Claims (10)

1., for discharging a system for excess fluid from the region of patient body, this region is defined by tissue, described system bag Include:

Draining clip, described draining clip has:

Elongated leg, described elongated leg is configured for being distally advanced in tissue, described elongated leg have along The passage that this elongated leg extends, described passage includes that chamber, wherein said leg include that tubular body, described tubular body have Proximal open and distal openings, described chamber is between described proximal open and distal openings；With

Base portion, described base portion is arranged near the proximal end of described leg, and described base portion can be orientated to engage tissue； And

Configuration component, described configuration component supports described draining clip releasedly, and described configuration component includes activatable joining Put axle and at the distal extension of described draining clip so that penetrating the sharp distal end of tissue；

Can deforming at least partially of the leg of the draining clip wherein advanced so that described base portion and leg are by described draining Clip is attached to tissue, and excess fluid is transmitted along the passage of described leg from this region, and wherein said leg is by structure Cause to utilize the configuration axle being arranged in described chamber to be distally advanced, in order to suppression tissue enters in chamber,

Wherein said configuration axle is configured to proximad from chamber and regains, in order to fluid transmits along chamber, and

Wherein activating this activatable configuration axle outside tissue can make described leg deform so that this configuration axle causes leg Distally foot laterally bend, so that tissue is captured between foot and base portion.

System the most according to claim 1, this region includes the patient's eye of certain volume, and this tissue includes eyes group Knitting, wherein said draining clip is configured to along described passage transmission fluid to alleviate the excessive ophthalmic of eyes Pressure, the internal diameter of the passage of described leg is .002 "-.008 ", and the external diameter of described leg is .005 "-.013 ".

System the most according to claim 1, wherein said activatable configuration axle is included in the chamber of leg and distad prolongs Reaching wire rod or the axle of deformation body, the proximal movement of its axis laterally promotes described deformation body against foot, in order to make Foot deformities.

System the most according to claim 3, wherein said deformation body is included in described configuration component, and wherein Described deformation body is configured to when described configuration component is regained from patient be drawn proximally by described drainage clip Son so that pulling of described deformation body can stretch described deformation body to be stayed in tissue by described draining clip.

System the most according to claim 1, wherein said leg is included in multiple legs of drainage clip subsystem, institute State multiple leg to be configured to proceed in tissue, to provide multiple parallel drainage path, and wherein said base portion Cross between the first leg and the second leg in the plurality of leg.

System the most according to claim 1, wherein said leg is configured to adapt to after configuring to described logical The regulation in road, the regulating flow quantity of the draining clip configured to provide fluid to pass through.

System the most according to claim 1, wherein said drainage clip attached bag includes biocompatible ductile material, this biology Compatible ductile material is selected from the group including following material: tantalum, gold, platinum, titanium, rustless steel or plastics.

System the most according to claim 1, the outer surface part of wherein said draining clip carry out colouring with tissue Join.

System the most according to claim 1, wherein said draining clip is further configured to for eluting or using medicine Thing.

System the most according to claim 5, at least two leg in wherein said multiple legs is configured to by causing Move the activatable configuration axle of described configuration component and deform simultaneously.