CN105142544A - Interference-relief type delivery detachment systems - Google Patents

Abstract

Various features are described that are adapted to improve performance of interference-relief type delivery systems. A delivery system provided herein comprises an implant comprising a socket at a proximal end of the implant; an elongate sleeve having (i) a proximal section, (ii) a distal section slidably disposed within the socket, and (iii) a window between the proximal section and the distal section, the window extending through a wall of the sleeve; and a core member having a proximal portion slidably received within the proximal section of the sleeve and a distal portion extending through the window to a space outside the sleeve and within the socket. The distal portion of the core member provides an interference fit with the distal section of the sleeve within the socket until the core member is withdrawn.

Description

Remove interference type conveying piece-rate system

Related application

The application is the Application U.S. Serial No No.12/942 submitted on November 9th, 2010, the part of 209 continues application, described Application U.S. Serial No No.12/942,209 require the U.S.Provisional Serial No.61/259 that on November 9th, 2009 submits to, the priority of 585, described Application U.S. Serial No No.12/942,209 and U.S.Provisional Serial No.61/259, each in 585 is integrally combined reference in addition herein.

Technical field

The application relates to for by induction system, method and the structure in device patients with implantation body.

Background technology

The blood flow coming position in occluding vascular based on the embolization device of fabric and induction system interface can be used.A kind of purposes is in embolization of intracranial aneurysm or obturation and another kind of purposes is carrying tumor vascular occlusion (PVO) or sacrificing in (sacrifice).

Summary of the invention

Apply for, in the structure described, there is the fabric ball device being formed with the far-end of coincidence of a folding and the far-end of fold-flat people such as Becking.These structures are some devices being suitable for treating cerebral aneurysm most.Distal marker object space method is described to be especially suitable for these devices.In addition, near-end method for fine finishing is described to be suitable for these devices and other device that the people such as Becking apply for description.Similarly, whole in the characteristic sum technology that presents of the people such as Becking application (PCT/US2009/041313) all combine herein in addition reference.

About distal marker object space method, improvement comprises and is included in being connected in implant/for the tether of distal marker thing.Particularly, when label is attached to the proximate distal ends (as in the fold-flat embodiment in the application combined) of implant, the length of tether extends to the nearside lining of implant.The length of tether is set so that when implant is compressed, and label is pulled to be aimed at implant and/or conduit.

When stitching thread is used for tether, stitching thread can be fastened with the inside of least interference around folding part, distally.But, maybe advantageously because other reasons uses line ribbon (such as platinum or Nitinol).

That is, tether ribbon (especially when being made as V-arrangement in advance) can be threaded through gap/hole and around few line from fabric to.By layout like this, there is not the interference of the compression of the far-end to implant.Further, in tether ribbon the spring action of (being no matter comprise two filaments or be trimmed to a filament in curling, gummed, welding or after being otherwise attached at least one label) can help label to be positioned to when disposing implant against/cross over the top of implant.This ribbon also can contribute to the radiopacity of label, therefore allows less label size.

Another is chosen as and comprises the fiber relevant to tether and/or other thrombosis promotion material.No matter what material selected and/or feature that what provides extra, the near-end of tether be advantageously trapped between the layer of fabric or fabric and optional in arbitrary in band or outer band between.The near-end of tether can be attached by gummed by welding or other modes.

Another group improves the mode about polish implant." polish " means the nearside of process implant to limit the mode of lining and/or induction system separation interface.

In a favourable method (in wherein expecting to use band for piece-rate system parts (such as describing in related application) boundary), realize processing by the elongated hypotube (hypotube) be set in fabric.Hypotube (such as about 2-5 centimeter length) is as the device for keeping and handle implant prefabricated component structure.Extraly, when pruning pipe (or when pruning final implant relative to kept pipe or close to final implant), the hypotube remainder (current is " interior band ") in implant limits and is separated interface tube chamber.Similarly, especially when more radiopaque material of such as platinum/iridium alloy or cochrome is used for pipe, identical structure is by the radiopacity improved and/or provide implant proximal end required.

In a word, the method (it is characterized in that " sacrificing hypotube length " method alternatively), for gummed, also can apply solder technology.In fact, by finishing pipe to limit band in implant, for nearside to be exposed hole/port provides the protection for welding slag and deformation, the method may be particularly useful in solder technology.Namely, after being welded, neat cutting part (such as by diamond saw, cut, EDM etc., described above) can be formed and any removal deburring operation (by mechanical movement, etching, EP or other modes) can be performed as required on the face recently exposed.

Combine with for the sacrifice hypotube length method glued together or the original gluing method described in application reference, the selection providing another favourable by step after different process.That is, band is used for the proximal end of implant with after the outer pouring piece border being defined for binding agent/adhesive (such as Loctite4014) outside, can remove outer band subsequently, thus makes the adhesive pouring piece of below in place.The height removing the nearside characteristic size that can reduce implant of outer band, diameter and outward appearance.Therefore, its can auxiliary development have 0.021 " conduit intersects the system of profile.

For the ease of removing, band can advantageously comprise Nitinol (it forms passivation layer natively), or band can carry out applying or otherwise being electroplated.Titanium nitride coating can be desirable.The dip coating of spraying in the demoulding (such as 3M) or the demoulding can be alternately adopted after applying binding agent and solidification, to slough band to assist.Otherwise band can be excised by from gummed pouring piece.

Another method for realizing minimum implant insert diameter while the radiopacity keeping necessity relates to the top (such as with straight line) platinum band being attached to interior NiTi band.Nearside/lower NiTi section can by the NiTi fabric be easily soldered in spheroid (when being so constructed), and platinum provides (comprising platinum/iridium alloy and other alloys) the radiopaque label of alignment.Piece-rate system controls and anchor lines is received through two bands.Band can be attached to one another (such as by welding, gummed or seam) or be only associated with each other, till removing piece-rate system line.In either case, band can comprise interference engagement, splice or other grooves or tongue-and-groove feature, to make or the auxiliary connecting portion made between body.

Another group improvement relates to the shaping of the far-end of " folding smooth " types of implants.This implant can be provided with smooth top.Smooth top source idiomorphism is formed in the par in circular tool, and fabric is formed in described circular tool.By from profiled member mill off about 0.010 " can par be generated.Enough " platform " for required shaping is allowed in the cutting of this degree of depth, and can be applied to diameter dimension be all the time implant from about 5 millimeters to 12 millimeters and almost do not affect the shape perceived.Pleated portions in the implant line be shaped by this profiled member is disposed for implant and is provided direct advantage.When par being placed to the far-end of very approaching device, when implant unloads lower jacket, around flat top bending/shape of pleated portions recover to drive comparatively early the opening of implant (with the pleated portions formed around par be set to farther-or pleated portions is not provided situation compared with).

Another group implant described herein improves the density that spheroid is described.In other words, provide the additional layer of fabric material to reduce fabric matrix porosity further, and it is compatible meanwhile may not increase device intersection profile/conveying (micro-) conduit.

These improvement relate to fabric third layer, and described fabric third layer is added into two layers preferably Already in folded in smooth base portion implant structure.In a combined scheme, the third layer of fabric to be trapped between two layers and to be trapped in lining region, but is being trimmed close to distally coincidence of a folding/flat sections place.In another combined scheme, internal layer be set in aforementioned two layers coated in.Internal layer is advantageously attached to the far-end of the internal labeling thing band of provided any external labeling thing band (top/distally).Therefore, the attachment of fabric will not increase lining profile.The increase of any profile in the end in order to avoid implant, will repair internal layer usually, and to make when implant is compressed, the reduction length of internal layer is located in the nearside of the coincidence of a folding fabric of the far-end of implant.Time in its non-form that is tied, internal layer can limit cup simply.Alternatively, internal layer can limit the second spheroid form.This spheroid form can be spherical or avette substantially.A favorable structure also comprises the far-end not ending at fabric.The end limiting the fabric of interior spheroid can be secured to band or be welded together.By structure like this, they can be provided in the another kind of radiopaque marker feature in spheroid.But, preferably, the fabric end of internal layer (cup-shaped body, spherical form, or otherwise) for what do not stop.Therefore, they can improve the thrombosis in patient body.

Finally, the improvement of induction system is described.Described feature as above-mentioned feature, with context-sensitive " improvement ".Such as, some induction system structure can not be as other space availability ratio high.But this larger system can be desirable, reason is to manufacture complexity and/or cost reduction.

Such as according to multiple aspect described below, this technology is described.Multiple examples of the aspect of this technology are conveniently described as the clause (1,2,3 etc.) of numbering.These exemplarily provide and do not limit this technology.It is emphasised that arbitrary in dependency clause can combine in any combination, and be placed in respective dependent/non-dependent clause, such as clause 1 or clause 55.Other clause can be presented in a similar fashion.

1. an induction system, comprising:

Implant, described implant is included in the socket of the proximal end of implant;

Elongated sleeve, described elongated sleeve has (i) proximal section, (ii) is arranged in distal section in socket and (iii) window between proximal section and distal section slidably, and window extends through the wall of sleeve; And

Core component, described core component has: portions of proximal, and described portions of proximal is received in the proximal section of sleeve slidably; And distal part, described distal part extends through window and space socket in outer to sleeve;

Wherein, the distal part of core component provides the interference engagement with the distal section of the sleeve in socket, till core component is retracted.

2. the induction system according to clause 1, wherein, core component is circle line, and each in the proximal section of socket, sleeve and the portions of proximal of heart yearn is aimed at all coaxially.

3. the induction system according to clause 1, wherein, the distal section of sleeve at least partially with axially the aiming at least partially and radially adjoining of the distal part of core component.

4. the induction system according to clause 1, wherein, heart yearn comprises distally spheroid.

5. the induction system according to clause 1, wherein, sleeve comprises distally spheroid.

6. the induction system according to clause 1, wherein, sleeve comprises multiple otch of the length along sleeve.

7. the induction system according to clause 5, wherein, described multiple otch is located on the sidepiece replaced of sleeve.

8. the induction system according to clause 1, is also included in the insertion section in the distal section of sleeve.

9. the induction system according to clause 1, wherein, insertion section limits the surface relative to the central axial line inclined orientation of sleeve.

10. the induction system according to clause 9, wherein, the side on described surface is connected to window.

11. induction systems according to clause 9, wherein, the active force that the distally against the core component on described surface is pointed to makes core component deflect through window.

12. induction systems according to clause 1, wherein, the distal section of sleeve limits the surface relative to the central axial line inclined orientation of sleeve.

13. induction systems according to clause 12, the active force wherein pointed to against the distally of the core component on described surface makes core component deflect through window.

14. induction systems according to clause 12, wherein, the side on described surface is connected to window.

15. induction systems according to clause 1, wherein, core component comprises ribbon, a part smooth placement against insertion section of ribbon.

16. 1 kinds of methods, comprising:

Guide induction system to implant position;

The interference engagement of the distal part of core component from the distal section with the sleeve in the socket of implant is regained, thus distal part is retracted in the proximal section of sleeve by window;

Sleeve is regained from socket, is disengaged with core component and sleeve to make implant.

17. methods according to clause 16, wherein, while guiding induction system to implant position, maintain the distal section interference engagement of the sleeve in the distal part of core component and the socket of implant.

18. 1 kinds of methods of assembling induction system, comprising:

The distal section of elongated sleeve is inserted in the socket of implant;

The distal part of core component is inserted through sleeve;

Make the window of distal part through sleeve of core component;

The distal section of the sleeve in the distal part of core component and the socket of implant is made to be engaged to interference engagement.

19. according to the method for clause 18, wherein, makes the distal part of core component comprise through window the active force providing distally to point to core component, thus deflects core component by the surface of the distal section of the sleeve of the central axial line inclined orientation relative to sleeve.

This implant and conveyer device, the external member comprising it, use and manufacture method are all included in the scope of this description.Some aspects of this manufacture are more than described.More detailed discussion is presented below in conjunction with accompanying drawing.

The extra Characteristics and advantages of this technology will be suggested in the following description, and partly will be apparent from explanation, or can learn by putting into practice this technology.By the structure pointed out particularly in its written description and claim and accompanying drawing thereof, the advantage of this technology will be implemented and obtain.

Should be understood that foregoing general describe and following describe in detail be exemplary and indicative and be intended to provide as the further explanation of this technology stated.

Accompanying drawing explanation

Be included to provide to the further understanding of this technology and combined and form the accompanying drawing of a part of this description, describe this technology aspect and with description together for explaining the principle of this technology.

Figure 1A and 1B illustrates respectively and to be expanded and by the implant with label tether compressed.

Fig. 2 A and 2B illustrates another far-end with the label embodiment of tether and side view respectively.

The detailed view of Fig. 3 flag activation thing/tether sub-component.

Fig. 4 diagrammatically illustrates the assembly be set in implant in figure 3.

Fig. 5 illustrates and is prepared for the accurately machined implant prefabricated component of near-end.

Fig. 6 illustrates soldered near-end.

Fig. 7 illustrates according to the preparation of another method for the accurately machined implant prefabricated component of near-end.

Fig. 8 illustrates near-end that is cut and welding.

Fig. 9 A and 9B illustrates the implant adopting the near-end method for fine finishing substituted, and the detailed view of little profile embodiment is shown in figures 9 b and 9.

Figure 10 A and 10B illustrates the radiopaque feature of extra near-end that together can use with multiple end method for fine finishing.

Figure 11 illustrates the implant by being formed with distally flat top.

Figure 12 illustrates that the some different implant for intended size scope gives the implant model of implant shape as shown in Figure 11.

Figure 13 A with 13B illustrate respectively according to the implant of Figure 11/12 design shape with not according to the operation compared with the implant of Figure 11/12 design shape.

Figure 14,15,16 and 17 diagrammatically illustrates the implant of the density compared with the structure presented in the diagram.

Figure 18 illustrates the summary view of the implant/piece-rate system that can use together with the present invention.

Figure 19 A, 19B, 19C, 19D, 19E, 20A, 20B, 20C, 20D and 20E illustrate the operational phase (being respectively handle side and implant side) of system shown in Figure 18.

Figure 21 illustrates the optional improvement for identical systems structure.

Figure 22 A and 22B illustrates alternative transport system interface that is engaged and that be disengaged respectively.

Figure 23 A illustrates the end-view of the induction system interface as represented in Figure 22 B.

Figure 23 B and 23C illustrates the alternative end-view of the structure of the push rod shaft in identical systems.

Figure 24 A and 24B illustrates the alternative transport system interface selection (be engaged respectively and be disengaged) according to the push rod shaft structure in Figure 23 C.

Figure 25 illustrates the members view of the embodiment relevant with the embodiment in Figure 24 A and 24B.

Figure 26 illustrates and the alternative implant side interface that the induction system that presents in Figure 24 A and 24B is had a common boundary.

Figure 27 A, 27B and 27C illustrate and are similar to the push rod side structure substituted the implant side interface presented in fig. 26, and its detailed view improved are described.

Figure 28 A and 28B illustrates alternative joints for being similar to the system shown in Figure 22 A and 22B/be disengaged interface.

Figure 29 and 30 illustrates another joint/disengagement feature for each in type of braid implant and embolic coil respectively.

Detailed description of the invention

In following description in detail, a large amount of concrete details is proposed to provide the complete understanding to this technology.But, it is obvious to those skilled in the art that and can put into practice this technology without the need to some in these concrete details.In other examples, do not illustrate that known structure and technology are so that not fuzzy technology in detail.

The such as phrase of " aspect " does not imply that this aspect is absolutely necessary for this technology or this aspect is applied to the possessive construction of this technology.The invention relating to an aspect can be applied to possessive construction or one or more structure.An aspect can provide one or more example of the present invention.The phrase of such as " aspect " can refer to one or more aspect, and vice versa.The such as phrase of " embodiment " does not imply that this embodiment is absolutely necessary for this technology or this embodiment is applied to the possessive construction of this technology.The invention relating to an embodiment can be applied to all embodiments or one or more embodiment.An embodiment can provide one or more example of the present invention.The phrase of such as " embodiment " can refer to one or more embodiment, and vice versa.The such as phrase of " structure " do not imply this structure this technology is absolutely necessary or this Structural application in the possessive construction of this technology.The invention relating to structure can be applied to possessive construction or one or more structure.A structure can provide one or more example of the present invention.The phrase of such as " structure " can refer to one or more structure, and vice versa.

Turn to accompanying drawing, Figure 1A and 1B illustrates implant 10.In figure ia, the lining of implant 10 (invisible) is only had to be received in sheath or conduit 2.About 40% of implant 10 is received in the sheath 2 in Figure 1B.Radiopaque label 20 (such as platinum band) is all visible in two views.As described in people's applications such as Becking, and with further reference to accompanying drawing 4, implant 10 comprises and is positioned tether 22 adjacent with the folding part, distally 16 in fabric between braid layer 12 and 14, and folding part, described distally 16 limits hole 18 (being also referred to as the hole in fabric or gap herein).Label 20 is kept by tether 22.Tether 22 also can assist the closed or openable size of restriction hole 18.

Although tether 22 ends near label 20 in people's applications such as Becking, it extends to the nearside lining 30 of implant 10 in this manual.Extend " tether " partly or the operation that is so arranged of component 24, to guarantee when implant is trapped in axially aligning of tense marker thing 20 in (especially when again catching) conduit/sheath.

Therefore the length of tether member 24 be set to exist when implant is extended lax (as shown in figure ia), and eliminated when implant fully compresses or tend to compression lax (as shown in fig. ib).

Although the tether illustrated in figs. 1 a and 1b and/or tether member are made up of suture material usually, but it also can be made up of any other biological compatible material, comprise rustless steel, titanium, Nitinol (may be martensitic line under body temperature, usually be referred to as " myofilament ") etc.When adopting suture material, it can be fastened with the inside of the mode of least interference around folding part, distally 16, and at position 26 place knotting (see Figure 1A), with the position of easily fastening label 20.Identical method can be realized by very thin line (such as 0.001 inch round line).

Or, advantageously because other reasons uses tape (such as platinum or Nitinol).In the following figures in detail structure is described in detail, described structure uses hyperelastic NiTi ribbon, and size is set in about 0.001 inch is multiplied by about 0.003 inch.

Thermal finalization is that the tether ribbon 22 of tight loop or V-arrangement is threaded through gap 20 and at the far-end of implant 10 around the only single line from fabric, as shown in FIG. 4.By layout like this, tether ribbon 22 does not disturb the compression of the far-end of implant substantially.Also have, the spring action (no matter comprising two filaments or be trimmed to after curling, gummed, welding or attached flag thing 20 as shown in Figure 3 and only have a filament (as indicated by a dotted line)) in tether ribbon can help when disposing label 20 to be positioned to the top against (or leap) implant 10, as shown in Figures 2 A and 2 B.About attached flag thing, it is worth emphasizing that the paired ribbon section overlie one another has put forward good interface, curled markers thing 20 in described interface and significantly can not change the shape of label.

Further, the length of tether can be set as substantially " question mark " shape alternatively, to mate the curvature (tether such as, as occurred in the diagram) of (or coordinating more closely) implant when not carrying the baby.Design the shape of tether in advance with " coupling " (or mating approx) one or more implant size, this can assist in ensuring that the predictable and similar implant performance containing a series of different implant size and decrement.

As mentioned above, another improvement for this implant relates to the accurately machined mode of near-end.Fig. 5 illustrates and prepares for the accurately machined implant prefabricated component 60 of near-end.Now, the implant prefabricated component 60 such as prepared in people's applications such as Becking is ready, and makes extra pendency section 50 extend past proximal marker thing band 32.In many aspects, installation process is similar to the situation shown in Figure 13 A of people's applications such as Becking, and implant prefabricated component 60 comprises pipe 34 and the assembly be set in axle 52 in NiTi.In order to the position of maintaining member as shown, application adhesive (such as Locitite4014).Nonetheless, with reference to figure 6, lining region 30 can be welded effectively by welding bead 54, thus combines the fabric 50 of pendency, interior pipe 34 and at least outer platinum band 32 of positioning welding.It is emphasized that the welding result realizing this intimate the best by the stable fabric of (or entering) adhesive is surprising result.In other words, this be not welding (laser or other modes) field technical staff can predict or expectation arrive.Under any circumstance, the length being incorporated in the fabric depending portion in welding bead 54 can change according to some factors, comprises implant diameter, linear diameter, braid density etc.As shown, depending portion is about 0.005 to about 0.010 inch in length.

Composition graphs 7 describes another near-end method for fine finishing.Particularly, prefabricated component 62 is trimmed and stablizes for welding unlike shown in Fig. 5.In fact, prefabricated component 62 is ready in elongated hypotube 54.Hypotube body provides the device for keeping the structure of braid layer 12 and elongated " afterbody " section of stable braid layer 12 and/or the layer on it 14 (such as by twister 58).

When defining narrow window (about 0.010 to about 0.025 inch of the fabric such as preferably exposed), apply laser energy over larger areas as shown.Energy is enough to fabric to be soldered to hypotube.But hypotube is not soldered to optional below axle 52 by soldering.

After so welding, most of length of hypotube 54 is by " sacrifice ".Hypotube is trimmed to limit band 34 in implant, as shown in FIG. 8.In this, band can be provided in some or all in radiopacity required in lining region 30.But outer band (if especially comprising platinum) can by positioning welding to fabric, as indicated by arrow Z in the figure 7.

No matter whether comprise external labeling thing band, Fig. 8 illustrates the advantage of method for fine finishing, namely avoids the welding bead flow artefacts (as seen in Figure 6) relevant to the surface tension at body end place.But weld part 64 is by faced by nattily, and the interior tube chamber of remaining band 34 is removed burr and/or fraising.Correspondingly can minimize actual liner size and form liner size.

Fig. 9 A and 9B illustrates another the favourable near-end method for fine finishing for minimizing nearside liner size.Fig. 9 A illustrate when implant substantially look be attached by adhesive or welding time the implant with external labeling thing band 32.When being attached this band by adhesive, once adhesive pouring piece is formed at wherein, just band can be removed.Implant 10 ' will comprise nearside lining 30 ' subsequently, and described nearside lining 30 ' diametrically reduces (reaching about 0.004 inch according to beam thickness difference) and more not easily discover by providing lower contrast.Health outer (such as on the packaging), doctor physician, using the bright finish seen as the binding agent/adhesive 70 of pouring piece 72 or gloss, embedded in fabric but not high-contrast label 32 in described pouring piece 72.

Although seem inessential for function, this visual aspects can be in fact meaningful.The impression of doctor physician observation nearside feature noumenon can affect doctor physician and whether receive this product.Traditional implant has been designed to nearside lining and has been inserted in the internal capacity of implant completely.Make the outward appearance of implant for more attractive doctor physician like this.But result implant is impaired in performance, and (such as, implant is more difficult to again catch; Recover to force implant to insert the demand that shape improves linear dimension to implant and intensity, thus cause the undesirably increase of implant size; And other performance deficiencies).In in of the present invention, reduce the liner size of expection, this improves visual attraction and does not damage performance.

Figure 10 A with 10B illustrates the outer band of removing, provides the Additional examples of composition of the radiopacity of relative increase simultaneously.Particularly, by radiopaque band feature being repositioned to and the straight layout of interior band 34, minimized implant liner size can be realized.Simple platinum band 74 can be set in above interior band 34, as shown in Fig. 10 A.These components can link together by using traditional technology (such as gummed, soldering, welding etc.), or by using lock 76 and key 78 feature by the induction system interface component application shown in Figure 18 etc. to the interlocking member 34 and 74 of Figure 10 B embodiment, these components are retained to each other provisionally.

In conjunction with Figure 11 and 12, another implant features is described.Implant comprises the flat top 80 adjacent with distally hole 18 alternatively.By being provided for the platform surface 82 limited in the molded element 88 of implant body shape, produce flat top.Different size 88,88 ', 88 shown in Figure 12 " molded element or " model ".This molded element is milled out, to limit the par 82 surrounded by edge 84 by spherical model.Edge generates the pleated portions 86 in fabric line.It is emphasised that plane 80 and pleated portions 86 illustrate with the view replaced in Figures 2 A and 2 B.

In implant prefabricated component heat-setting process, it has been found that flat sections improves the quality of the folding part, distally 16 in implant, thus help to maximize the uniformity and the bending radius minimizing line.Therefore, the device tracking ability through tortuous anatomical structure in conduit is also improved.The pleated portions being set in the edge of the flat site in implant also contributes to transportation performance when disposing.Particularly, as illustrated in figure 13a, pleated portions 86 represents the multiple bending sections in the line forming implant fabric substrate.Once go out from microtubular, then bending section recovers, and causes implant far-end to open wide more, as (also seen, implant in fig. ib) as shown in Figure 13 B than the implant without this pleated portions.As more unlimited body, implant is more soft, and by more lax fabric angle, implant should contact the tissue-such as aneurysmal dome of any fragility.

The change of other structures or the viewpoint of implant can be applied to shown in Figure 14-17.Each method provides the probability diagrammatically improved relative to density the father's structure illustrated in the diagram.

Particularly, implant 90 comprises the middle braid layer 92 be set between outer 12 and internal layer 14.Middle braid layer 92 is trapped in lining 30, as other layers in proximal attachment portion 94.Distal extension portion 96 can be set in some positions.Advantageously, distal extension portion 96 extends into mid point (half-waypoint) around device or equator (equator).By this method, layer will be conducive to implant density (or in other words reducing porosity), even if be also like this for wide Jugular vessel tumor.

As shown in Figure 14, the distal extension portion 96 of fabric is adjacent with the coincidence of a folding section 16 of implant.Now, density is the highest, thus interior layer line will be tended to keep best being limited by between layer 12 and 14.But, because folding part 16 (this can be the maximum profile aspect of implant) is not disturbed in end 96, so there is no or almost not increase intersection profile.

When producing, can by prefabricated component (being similar to prefabricated component 62) being cut into two halves at folding part, distally place and generating the internal layer 92 of implant simply.This generation can be used to from two interior interval groups in two different devices of same formation process.In any case produce, because internal layer can depend on for other fixed layers of ceiling structure, therefore internal layer can be made up of line more very thin compared with other layers and/less fabric number.Such as, internal layer can comprise 72 end, 0.0008 inch of line fabric, and skin comprises 96 end, 0.0008 inch of line fabric.But, otherwise also can be correct, wherein internal layer is more sane.Under any circumstance, advantageously make the quantity of the thread end be included in fabric not mate (as in the example above) to help to avoid lines matching, therefore reduce porosity.

Implant 100 shown in Figure 15 illustrates for improvement of flow disruption effect and does not increase another favourable method of device intersection profile.As in device 90, adopt middle braid layer 90.But its near-end is not secured in lining, therefore loosen the space constraint in this region.

In fact, fabric matrix integrity is maintained by applying by polymer-coated braid layer (such as being applied by the TICOPHILIC of Lubrizol, Inc.) or other or process.Hydrogel coating also can be a kind of selection well, is such as licensing to the U.S. Patent Application Serial Number 6,905 of the people such as Won, the hydrogel based polymer mesh thing can catching therapeutic agent described in 700.Similarly, although implant components advantageously comprises braided Nitinol thing (being generally super-elasticity NiTi), but but can comprise polymer for the fabric of any layer, especially high strength biodegradable polymer, such as MX-2 (MAX-prene), synthesis Absorbable rod monofilament (90/10 Acetic acid, hydroxy-, bimol. cyclic ester/L-lactide) and/or G-2 (glycogen), synthesis Absorbable rod monofilament (Acetic acid, hydroxy-, bimol. cyclic ester (PGA), 6-caprolactone (PCL), polytrimethylene carbonate (TMC) co-polymer), described high strength biodegradable polymer is shaped (such as 110 degrees Celsius one hour) by thermal finalization and/or is coated with above-mentioned material to stablize fabric substrate as mentioned above.

Implant 110 shown in Figure 16 is provided for improving embolus (or flow disruption) effect and does not have or almost do not have another method influential to intersection profile.This effect is realized by penetralia/the 3rd braid layer 112 is attached to interior band 34 at its near-end 114 place.Penetralia/the 3rd braid layer can soldered, gummed, soldering or be otherwise attached to interior band.The far-end of fabric 116 can be trimmed as shown or otherwise and be formed.Such as, the cup so formed closely can follow the inner rim of device until arrive or cross its equator.

As the combined scheme in accompanying drawing before, the third layer be incorporated in in implant is together disposed and recapture with the remainder of implant simply.But, although the unique distinction of the structure of Figure 16 is that the near-end 114 of fabric is by stably fastening, be fastened into make it namely not need the space of (such as label band 32 is interior outside) in lining without the need to overlap spatially.

Relevant implant structure shown in Figure 17.Now, in implant 120, adopt identical near-end 114 attachment method.But, with the internal layer of fabric is formed (such as passing through thermal finalization) cup-shaped unlike, define interior spheroid 118.The proximal portion of spheroid improves whole nearside implant density, and in implant, defines flow stagnation region A and B separately with the thrombosis in further auxiliary implant.

Interior spheroid body 118 can set shape on model.Alternatively, and more advantageously, can by fabric is got together and braiding system is fastened rope on axle for thermal finalization, shape can be formed when there is no outside or inside model.This " model-free " method is functionally favourable, and reason is that it maximizes fabric angle in final body (and thus density).But as long as the outer body of the implant only limited by braid layer 12 and 14 contacts with aneurysm, so produced any in shape inconsistent is all controlled.

No matter how it is formed (and specific knit construction is selected) interior spheroid in structure 118, all by be constructed to make when device be used for carrying by compressing or recapture time do not disturb the far-end of implant body/shell and/or label and tether.

More generally, Figure 18 provides the summary view of the implant side of therapy system 200.System comprises implant 10 (90,100,110,120) and is finally attached to push rod housing or the conduit axle 210 of handle 220 (such as, as shown in Figure 19 A-19-E).Can according to herein and/or the instruction of combined in addition reference construct in these parts any one.

A handle construction comprises single plunger.Plunger tractive lasso, described lasso engages the socket be connected with line with tractive step by step; First each control line 212 is pulled (one next), and anchor lines 214 is pulled subsequently.In Figure 19 A-19E and 20A-20E, this action is described.Figure 19 A and 20A illustrates from packing the device feature removed.Figure 19 B illustrates to rotate 120 degree and release lever plunger 222 relative to handle body 224.This action does not have effect to the separation interface 216 shown in Figure 20 B.But the progressively tractive of the plunger in Figure 19 C-19E causes the release of system, as shown in Figure 20 C-20E.

Figure 21 illustrates the optional improvement of the structure of system 200.Now, system 200 ' have be received in implant 10 lining or interior band 30/34 in only " truly " control line 212.Nonetheless, by control line and grappling spheroid 216 (such as, as formed by laser or as otherwise constructed) interaction, implant keeps securely/be attached to conduit axle still.

If gone forward one by one to the step in 19E and 20E from the step among Figure 19 C and 20C, then release implant.But the 3rd (float or activate) " virtual " (dummy) line 218 is still loaded in the tube chamber of push rod shaft 210.The use of this line maintains the close packed of line in axle 210 and arranges, this is very important when determining the position of tortuous environment center line.But release angle can be increased and plunger traction force can be reduced, reason is that the line in implant has the greater room of allowing for space storage betwixt.

It is emphasised that the length L that line 218 is placed in push rod shaft can change according to object.Line can not be inserted (such as substantially against implant near-end).Line only can be placed into about 1 millimeter, thus any forward travel in tortuous environment does not cause the contact with implant.Or it is flexible with the distal tip improving conveying push rod shaft 210 that line can be placed into larger degree (such as between about 1 centimetre to 5 centimetres).

Figure 22 A and 22B illustrates the induction system interface substituted in engagement state and disengaged condition respectively.Now, system 230 is included in the auxiliary lower conduit/push rod housing 232 activated of typical torque device 234.Torquer 234 locking comprises the position of the Central Line 236 of the grappling spheroid carried for implant 10.By the band 240 (being also as the platinum band of label alternatively) that can be attached to conduit, buffer part or shoulder are set, with the lining 30 against implant for promoting.Alternatively, the total length push rod sheath 240 ' be received in slidably on sheath 232 can be set, for following purposes.

In any case structure (such as whether using terminal band 240 or the total length sheath 240 ' concentric with sleeve 232), when grappling spheroid 238 is in retracted position, the joint between implant and push rod shaft 232 is realized with the extension 242 of band 34 one-tenth interference relationships in implant, as shown in Figure 22 A by being offset to.When line 236 (and terminal ball body characteristics 238) is pushed into as shown in Figure 22 B, extension 242 is freely moved (to be such as back to its initial position by elastic reaction or when conduit axle is regained) and slide away from implant.In the operator scheme substituted (such as in the embodiment with total length outer sleeve 240 '), can realize being disengaged with the interference that unlocks by regaining sleeve 232, and not advance anchor lines 236 and spheroid 238.

Under any circumstance, Figure 23 A is the end-view of the induction system interface as represented in Figure 22 B.As shown, once line 236 is pushed into and/or sleeve 232 is retracted, then do not exist interference between spheroid 238 and/or extension.

Figure 23 B shows line 236 and spheroid 238 similar view not in place.Figure 23 B illustrates extension 242 and catheter body 232.Further, be formed in one way (such as being cut away by 90 degree) although extension 242 and catheter body 232 are illustrated as, should be understood that extension can be formed by inclined cut or other modes.In fact, Figure 23 C shows a kind of method, in the process by promoting catheter wall side and touch opposite side and alternatively by parts 242 and 242 ' thermal finalization, fusion or glued together and form extension.In addition, axle 232 can be modified as has cut-out feature along its length, thus provides flex capability advantage.

Figure 24 A and 24B illustrates alternative transport system interface 250 option (engaged respectively and be disengaged) based on the push rod shaft extension structure in Figure 23 C.Because the wall thickness that provided by Double-wall-layer increases, therefore system can as the work as shown in Figure 22 A and 22B, except the distally interference characteristic (such as grappling spheroid/band) without the need to separating.Therefore, releasing is disturbed and unlocks push rod housing 232 (particularly, the extension be associated) by the withdrawal of line 236, regains for from implant 10.

Figure 25 is the members view of relevant embodiment, and sleeve 232 ' is as the base portion or the basis that are used for grappling spheroid 238 in the described embodiment.This spheroid can be formed in the end of sleeve in a number of ways.Method adopts metal hypotube (such as rustless steel, cochrome or Nitinol), described metal hypotube etched or cut to limit elongated " line " extension 231.Subsequently, by utilizing laser energy, online end forms spheroid.Alternatively, by welding, cylindrical band etc. can be attached to spheroid.

Extraly, in hypotube sleeve, cut-out pattern 235 is advantageously generated to improve bending property.Otch 233 replaces and/or spirality on the either side of control line.As is known, this pattern can provide and bend without biased.Kerf widths can be between being greater than between 0.002 inch and about 0.010 inch.When adopting larger (illustrate in such as Figure 25 about 0.5 to about 3 millimeters) otch/section, control line maintains in alignment with in middle position by this way.

As shown, core component 236 is received in sleeve 232 ' with one heart, and sleeve is positioned at outer catheter/push rod sheath 240 ' with one heart.Oversheath can be used to encapsulate the sleeve bending adjustment and the hydrophilic coating carried for lubricating.In addition, sheath member can in conjunction with terminal label thing band.

Figure 26 illustrate alternative with Figure 24 A and 24B in the implant side interface of induction system that presents.Implant socket 260 is now provided.Socket 260 can be attached to the cup 262 of one or more implant braid layer (12/14) by by welding or other modes and be limited by the deceleration organ pipe 264 that spiral, pressing or other modes are attached in the near-end of cup.It is emphasised that, by this layout, implant can be realized when other nearside interface without the need to being configured near the shoulder 240 of the near-end of implant or the axle 210 be similar in below or sheath 240 ' and promote.

In fact, motive force and traction force (for regaining) can be produced in socket indoor.Although the interface that this socket will illustrate before being usually greater than, it is easy to renovate or be used as and substitute the screw-type method for releasing adopted in the many blood vessel sacrifices such as sold by AGAMedical, Inc. and other companies and closing device.

Induction system structure in Figure 27 A-C illustrates identical implant interface 260, and it is with the push rod side engagement/be disengaged (or breech lock) structure 270 substituted.The simple version of the structure shown in Figure 18 of the people such as this structure is Becking cited above application.Particularly, push rod shaft sleeve 272 (such as metal hypotube) is provided with single window otch 274.Window (being constructed to square cutout, circular or simple section) operates as side ports, thus allow that core component 276 (such as NiTi ribbon) passes wherein, and in facial 278 places interference against push rod shaft far-end, to prevent induction system to be separated, till core component is regained.

But, this induction system structure (be no matter as described in the application of quoting by with implant size socket method, or other) can as in Figure 27 A-C right side detailed view in illustrated carrying out improve.Now, the distal part of otch is designed size and angle shifts away from tube chamber in sleeve 272 to be easy to core component 276.Extraly, insertion section 271 can be included in the far-end of sleeve, to support or to support control line (or smooth placement is against ribbon of insertion section) when being engaged to and coordinating with implant internal interference.The support of the inclination of overhang 273 and insertion section 271 (especially the two together) can be reduced in the some stress that is separated in interface and be easy to control member withdrawal, advantageously causes lower separation actuation force.Overhang 273 can limit the surface of another central longitudinal axis of central axial line or the system being transverse to or favouring sleeve 272.The surface of overhang 273 can be limited by the distal section 278 of sleeve 272 or insertion section 271.When providing the power against overhang 273 and/or the sensing distally on surface that is limited by it to core component 276, overhang 273 can deflect core component 276.Similarly, this makes it possible to use the more low intensive material for control member, all if provide the bending property of improvement and the polymer of lubricity.About production, cylindrical insertion section 271 can be soldered in the distal section 275 of sleeve 272 hypotube by press-fit, and subsequently by machining together to obtain the surface of coupling.Alternatively, the distal section of sleeve 272 can not have the solid material of interior tube chamber to be formed by the length of the distal section in window 274 distally.

Disclose the method for assembling induction system.The method can comprise and the distal section of elongate sleeve 272 being inserted in the socket 260 of implant.The distal part of core component 276 is pushed into through sleeve 272.The distal part of core component 276 is subsequently through the window 274 of sleeve 272.The distal part of core component 276 is joined so the distal section interference engagement with the sleeve 272 in the socket 260 of implant.

Figure 28 A and 28B illustrates other the alternative breech lock interface 280 for being similar to the system shown in Figure 22 A and 22B.In this system, the SheppardShi hook 282 of replication line plays the function of the spheroid in previous system.This system provides the advantage of very low production cost, and firmly anchor feature.Figure 29 illustrates system 290 the most closely-related with the system of Figure 21, except multiple control and/or dummy line are replaced by single ribbon 292.

Finally, Figure 30 illustrates piece-rate system 300.As in system 290, ribbon 292 can the doughnut alignment 214 of the spherical ancora 216 of combined belt together use.A kind of alternative method that can be used in arbitrary system is: adopt the ribbon as " anchor lines " and form interference characteristic by fastening knot (succedaneum as the spheroid formed for laser) in ribbon in the end of ribbon.This knot can be finalized, glues together or weld to stablize its shape.This knot can be reliably produced with low cost on the ribbon with very little size.Socket type interface can be formed in coil by the near-end that lasso feature 302 is assembled to coil.Lasso can be screw in (such as entering in coil with pitch).The method substituted is included in the flowing cored solder between coil and uses removable mandrel definition tube chamber wherein.Axle can be ready to be conducive to it by any way and remove, and comprises the mode for removable lining that the improvement described in composition graphs 9B describes.

In multiple induction system structure, conduit/push rod shaft can comprise simply extrudes portion (such as, PI, PET, PTFE, FEP, PEEK etc.), or traditional catheter configurations technology can be used to construct, and the fabric comprising liner supports oversheath (not shown).The exemplary constructions strengthening polyimides (BraidReinforcedPolyimide) as fabric can be obtained by MicroLumen, Inc..The distal section of polyimides can be melted and the Pebax melted replaces, and provides end that is more soft or progressive flexibility with conductive pipe.Load sheath to be usually arranged on push rod shaft.Advantageously, load sheath easily to divide.

If non-prestrain, so from after sterilization wrap (not shown) removes, implant is pulled to and loads in sheath.Load sheath to be received in the conduit lining of implant to be used to conveying, and implant is advanced in conduit.Subsequently, implant can be pushed into and dispose to therapentic part.Or, as before the final separation that illustrates in the patent application theme that combines, if necessary, implant can be retrieved replace another sized implant or reorientate.

In the present invention, this method can comprise and to locate to implant and to discharge each relevant doctor's behavior.Therefore, be contained in implant device location and dispose in methodology form a part of the present invention.This methodology can comprise and is positioned in cerebral aneurysm by implant or target is used for inaccessible carrying tumor blood vessel place or other application.In certain methods, consider the multiple behavior of the implant of Access artery tumor or year tumor blood vessel.

More particularly, some methods according to the present invention comprise the mode that such as induction system operates in arrival therapentic part process.Additive method relates to preparation system for carrying the mode of implant (such as fabric spheroid being attached to induction system).Any method herein can be implemented with the order of any event of enumerating feasible in logic and with the distortion revised a little of the precedence enumerated or these events or event order.

Aforementioned description makes those skilled in the art put into practice multiple structure described herein.Although this technology is described in detail with reference to multiple accompanying drawing and structure, should be understood that these only should not be considered to limit the scope of this technology for illustration of object.

Other approach for realizing this technology may be there are.Several functions described herein and element can with illustrate those differently split and do not depart from the scope of this technology.The multiple amendment of these structures will be apparent for a person skilled in the art, and the ultimate principle limited herein can be applied to other structures.Therefore, those skilled in the art can carry out many changes and amendment to this technology, and does not depart from the scope of this technology.

Should be understood that, the concrete order in disclosed technique or step level are the explanation of exemplary method.Different according to design preference, should be understood that and can rearrange certain order in technique and step level.Some in step can synchronously be performed.The element of the plurality of step of adjoint method statement in sample order, and do not mean the certain order or level that are limited to and have presented.

As used herein, phrase before a series of object one of " at least ", and for separately arbitrary object term " with " or "or", as a whole modification list, and each component (such as each object) in non-list.Phrase one of " at least " does not need to select at least one object; In fact, following implication allowed in this phrase: at least one in object in any one, and/or at least one in the combination in any of object, and/or at least one in each in object.Illustrate, phrase one of " in A, B and C at least " or one of " in A, B or C at least " each refer to and only have A, only have B or only have C; The combination in any of A, B and C; And/or at least one in each in A, B and C.

Term as such as " top ", " bottom ", " front portion ", " rear portion " etc. that use in the present invention is appreciated that and refers to arbitrary referential, instead of common Gravity Reference System.Therefore, top surface, lower surface, anterior face and posterior face upwards, downwards, diagonally or flatly can extend in Gravity Reference System.

In addition, " to comprise ", " having " etc. about the term used in this description or claim, this term refers to " to comprise " with term to have inclusive like that as the similar fashion understood during transition word in claim.

Word used herein " exemplary " means " exemplarily, example or explanation ".Any embodiment described as " exemplary " is herein preferred or favourable without the need to what be considered to compared to other embodiments.

The element mentioned in the singular does not also mean that " one and only have one " unless illustrated especially, but " one or more ".With the pronoun of male's form (such as he) comprise women and neutral (such as she with it) and vice versa.Term " some " refers to one or more.Underscore and/or the title of italic and subtitle only easy to use, do not limit this technology, and do not refer to relevant with the understanding of the description of this technology.Known or all structural equivalent functionally of the element of the multiple structure described by the present invention of running through known to those skilled in the art is combined clearly herein in addition with reference to and to be intended to cover by this technology.In addition, disclosed herein being not intended to is specific to the public, and no matter whether these are openly quoted in the foregoing description significantly.

Although described some aspect of the present invention and embodiment, present by means of only citing, and be not intended to limit the scope of the invention.In fact, the method and system of novelty described herein can be embodied in other forms multiple and not depart from its spirit.Appended claims and equivalent thereof are intended to cover these forms of falling in scope and spirit of the present invention or amendment.

Claims (19)

1. an induction system, comprising:

Implant, described implant is included in the socket of the proximal end of implant;

Elongated sleeve, described elongated sleeve has (i) proximal section, (ii) is arranged in distal section in socket and (iii) window between proximal section and distal section slidably, and window extends through the wall of sleeve; And

Core component, described core component has: portions of proximal, and described portions of proximal is received in the proximal section of sleeve slidably; And distal part, described distal part extends through window and space socket in outer to sleeve;

Wherein, the distal part of core component provides the interference engagement with the distal section of the sleeve in socket, till core component is retracted.

2. induction system according to claim 1, wherein, core component is circle line, and each in the proximal section of socket, sleeve and the portions of proximal of heart yearn is aimed at all coaxially.

3. induction system according to claim 1, wherein, the distal section of sleeve at least partially with axially the aiming at least partially and radially adjoining of the distal part of core component.

4. induction system according to claim 1, wherein, heart yearn comprises distally spheroid.

5. induction system according to claim 1, wherein, sleeve comprises distally spheroid.

6. induction system according to claim 1, wherein, sleeve comprises multiple otch of the length along sleeve.

7. induction system according to claim 5, wherein, described multiple otch is located on the sidepiece replaced of sleeve.

8. induction system according to claim 1, is also included in the insertion section in the distal section of sleeve.

9. induction system according to claim 1, wherein, insertion section limits the surface relative to the central axial line inclined orientation of sleeve.

10. induction system according to claim 9, wherein, the side on described surface is connected to window.

11. induction systems according to claim 9, wherein, the active force that the distally against the core component on described surface is pointed to makes core component deflect through window.

12. induction systems according to claim 1, wherein, the distal section of sleeve limits the surface relative to the central axial line inclined orientation of sleeve.

13. induction systems according to claim 12, the active force wherein pointed to against the distally of the core component on described surface makes core component deflect through window.

14. induction systems according to claim 12, wherein, the side on described surface is connected to window.

15. induction systems according to claim 1, wherein, core component comprises ribbon, a part smooth placement against insertion section of ribbon.

16. 1 kinds of methods, comprising:

Guide induction system to implant position;

The interference engagement of the distal part of core component from the distal section with the sleeve in the socket of implant is regained, thus distal part is retracted in the proximal section of sleeve by window;

Sleeve is regained from socket, is disengaged with core component and sleeve to make implant.

17. methods according to claim 16, wherein, while guiding induction system to implant position, maintain the distal section interference engagement of the sleeve in the distal part of core component and the socket of implant.

18. 1 kinds of methods of assembling induction system, comprising:

The distal section of elongated sleeve is inserted in the socket of implant;

The distal part of core component is inserted through sleeve;

Make the window of distal part through sleeve of core component;

The distal section of the sleeve in the distal part of core component and the socket of implant is made to be engaged to interference engagement.

19. methods according to claim 18, wherein, make the distal part of core component comprise through window the active force providing distally to point to core component, thus deflect core component by the surface of the distal section of the sleeve of the central axial line inclined orientation relative to sleeve.