CN101352375A - Endovascular aneurysm repair system - Google Patents

Abstract

Devices and methods for implanting prostheses capable of radial expanding in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. Also disclosed is an Endovascular aneurysm repair system.

Description

Endovascular aneurysm repair system

The application's dividing an application that be the exercise question submitted on October 15th, 2002 for Chinese patent application 02823552.5 (the corresponding international application PCT/SU02/32753) of " endovascular aneurysm repair system ".

The priority that the application requires to submit to November 28 calendar year 2001 No. 60/333,937, aesthetic state provisional application.

Technical field

The present invention relates generally to blood vessel prosthesis is attached to natural blood vessel, and relate to the method and apparatus system that is used to repair the vessel segment of falling ill and/or having damaged especially.

Technical background

By damaged or fall ill and weaken blood vessel wall and can cause vasodilation and form hemangioma.As not adding treatment, angiomatous big I increases and will finally break.

For example, the aortic blood tuberculation mainly occurs in the abdomen arteriosomes, usually the kidney lower area between renal artery and aorta fork.Aneurysm also can occur in the chest region between aortic arch and the renal artery.Aortic aneurysm breaks and can cause massive hemorrhage and fatality rate height.

Open surgery is changed the risk that vessel segment that fall ill or damage can reduce angiorrhexis.In this operation, the vessel segment of that excision is fallen ill or damage and installation or with straight configuration or the prosthetic implant made with the configuration of branching are for good and all adhered to suture then and are sealed on the end of natural blood vessel.The prosthetic implant of these operation usefulness usually is unsupported braided tube and typically uses polymer, ePTFE or other suitable material manufacture.Thereby vertically having, described graft do not support them can adapt to the modal change of hemangioma and natural blood vessel.Yet these operations need big operative incision and pathogenicity rate and mortality rate height.In addition, many patients are owing to other compound morbidity (co morbidity) is unsuitable for such major operation.

Introduced endovascular aneurysm repair to overcome the problem that is associated with the open surgery reparation.Aneurysm is put up a bridge with the blood vessel prosthesis of settling in the lumen of vessels.Typically, these arterial blood tuberculation prosthetic implant contract and use conduit through the femoral artery granting flatly.These grafts usually design the fibrous material of support (this Teng Shi support) structure attached to metal, and described metal rack expands or is inflated to contact the internal diameter of blood vessel.Different with the open surgery aneurysm repair, the graft of laying in the lumen of vessels is not sewn on the natural blood vessel, the laying process, penetrate natural endovascular barb but depend on from what support stretched out, or fixing on the throne with the expanded radially power of support itself graft.With joining ratio than the time, these graft attachment means do not provide the identical dynamics of adhering to, and may damage natural blood vessel when laying.

Therefore, the needs that such endovascular aneurysm repair system is arranged, described endovascular aneurysm repair system at first provides and can adapt to the prosthetic implant that angiomatous form changes and can not damage the laying of natural blood vessel ground, and next provides a kind of the graft type of permanent attachment is consolidated attached system in the independently blood vessel of blood vessel wall.

Summary of the invention

But the method and apparatus that is used for being implanted at body cavity the prosthese of expanded radially has been described.Especially, the invention provides and implant the intravascular stent of blood vessel and improving one's methods and system of stent graft, described blood vessel had both comprised that tremulous pulse also comprised vein.In the embodiment of example, stent graft places blood vessel to strengthen aneurysm, especially ventral aorta hemangioma.

In a first aspect of the present invention, by at first endoceliac implantation position place or near, for example the vasculature place of hemangioma one side or near, the support of at least one prosthese that expands.Behind the support of inflatable prosthesis, in stent area, introduce a plurality of holdfasts on the throne to the support anchor through prosthese.Described support can be elastic, typically contains shape memory alloy elastic stainless steel etc.For elastic support, expanding typically comprises from constraint release support so that support can be expanded voluntarily at implantation position.Described constraint can be radial constraint, that is, tubular conduit, granting sheath or analog place the configuration to keep support radially dwindling on the support.Expansion is achieved to allow support recover its larger-diameter configuration by pulling back on catheter sheath.In addition, support can be constrained for the configuration of axial elongation, for example passes through arbitrary end of support attached on interior pipe, bar, conduit or the analog, to keep support in configuration elongation, reduced.Support discharges to allow it expand voluntarily from such axial length constraint then.

Perhaps, support can for example have rustless steel or other metal manufacturing of malleability with the material that malleability is arranged.Expanding to contain then applies expanded radially power to cause expansion in support, for example the inflation support is provided conduit to cause expansion in support one side.

Blood vessel prosthesis can have various conventional configurations.In the arrangement of preferred vascular stent graft thing, prosthese typically contains the semi-transparent flexible barrier of being supported by support of blood such as fiber, and described support typically is the configuration of this Teng Shi support (stent).This Teng Shi support can have this Teng Shi configuration of any routine, for example in a zigzag, S shape, and expansible rhombus, perhaps its combination.Supporting structure can extend the whole length of graft, in some cases can be long than the fibre composition of graft.Perhaps, support will only cover the sub-fraction of prosthese, appear at 1,2 or 3 end.Be used for the treatment of the angiosomes of branching in configuration, for example treat the ventral aorta hemangioma, when stent graft stretched into in the common iliac artery, this Teng Shi support can have the end of three or more.In some cases, support can directly not connect at this independent supporting structure, but be connected on the fibre composition or other flexible composition of graft mutually along the whole length of stent graft or spaced apart on the major part of its whole length at least.

Introducing holdfast is typically initially settling prosthese to carry out later on.Should initially settle by expansion or airbag inflation carry out voluntarily, thereafter by introduce a plurality of independent holdfasts the fixing anchor in other words of prosthese on the throne, thereby described holdfast preferably is rotated the spiral type holdfast in " screw screw-in " prosthese and the blood vessel wall.Holdfast can promptly be avoided supporting structure only through fibre placement.Perhaps, holdfast can be introduced into and the part by supporting structure, selectively socket or the slit that is used to hold holdfast by special configuration.In some cases, certainly, holdfast will both also be introduced through the supporting structure top through fiber.

In the embodiment of example, holdfast is the holdfast of spiral, and their are by individually, and promptly one at a time, the pattern of opening with annular space on the inwall of prosthese is introduced.Usually, use the holdfast applicator of the single holdfast of carrying to introduce holdfast.The holdfast applicator of carrying single holdfast has smaller profile and can be more effective and less damaging than the holdfast applicator of a plurality of holdfasts of carrying.Yet, can conceive in certain embodiments the holdfast applicator and also can carry a plurality of holdfasts.And the holdfast applicator can be laid a plurality of holdfasts simultaneously with the space pattern that above-mentioned preferred annular space is opened.Usually, each end at the prosthese of wanting anchor discharges 2-12 holdfast.This 2-12 holdfast usually will be by dispensing in the row that single annular space is opened, and described holdfast can discharge in more than one row, and holdfast is axially aligned or is interleaved circlewise separately simultaneously.In a preferred embodiment, intracavity holdfast applicator of the present invention contains a guide member, described guide member, for example, contain and have the vertical tubular body of deflectable distal part, with apolegamy ground, be used for keeping the regulator of deflectable top facing to the graft position that will discharge holdfast.The applicator parts can insert and carry at least one single spiral or other holdfast through the cavity of guide member.Thereby being provided with rotary apparatus is used for rotating and advances spiral holdfast to make it to penetrate graft and blood vessels underneath wall on the throne to the firm earth anchor of graft.

The invention further relates to intracavity holdfast applicator, it contains and has the vertical tubular body of deflectable distal part; Configuration is made and is engaged blood vessel wall with the far-end that keeps described tubular body regulator on the throne; At the joystick of the near-end of described tubular body, it has control piece with deflection far-end independently, and lays and keep the far-end regulator on the throne that is deflected; And holdfast advances device, in being used for holdfast is advanced to blood vessel wall by distal engagement from far-end.In an embodiment preferred, holdfast advances device to contain the holdfast dispensing apparatus, and at least one holdfast be introduced and be carried to described holdfast dispensing apparatus can through tubular body.In another embodiment preferred, described holdfast dispensing apparatus contains flexibility bar, and described flexibility bar carries single spiral type holdfast at its far-end, and contains the device that is useful on rotation and advances spiral type holdfast penetrate tissue.In another embodiment preferred, described flexibility bar has helical trajectory, and described helical trajectory carries the spiral type holdfast and has and engages and rotate the spiral type holdfast to cause from the propulsive rotator line of health far-end.

Description of drawings

The present invention is understood from the embodiment of the present invention of following detailed description with reference to the accompanying drawings.In the accompanying drawings:

Fig. 1 is the perspective view of an embodiment of graft dispensing apparatus in the blood vessel, illustrates it and places in the abdomen arterial blood tuberculation;

Fig. 2 is a perspective view of laying an embodiment of graft in the blood vessel in the aneurysm of Fig. 1;

Fig. 3 is the perspective view of graft in the straight blood vessel of Fig. 2 of laying fully;

Fig. 4 is the perspective view of graft in the blood vessel of the branching laid fully, cuts open to show that at one end anchor support.

Fig. 5 is the perspective view similar to Fig. 4, and alternate supporting structure is shown;

Fig. 6 is the embodiment that perspective view illustrates the device that is used to guide the holdfast applicator;

Fig. 7 is that graft and support all were broken away after device that perspective view illustrates Fig. 6 inserted in the graft in the blood vessel that Fig. 3 lays.

Fig. 8 is the perspective view of the device of Fig. 6, and the starting of an embodiment of the stabilising arrangement that is attached to guiding device is shown;

Fig. 9 is the perspective view that is hinged on the Control Component shown in Figure 8 on the guiding device shown in Figure 6.

Figure 10 is the perspective view of the alternate embodiment of stabilising arrangement shown in Figure 8;

Figure 11 is the starting that perspective view illustrates the alternative stabilising arrangement of Figure 10;

Figure 12 is another embodiment that perspective view illustrates stabilising arrangement shown in Figure 8;

Figure 13 is a perspective view, and the starting of the stabilising arrangement of Figure 12 is shown;

Figure 14 is an embodiment of holdfast applicator;

Figure 15 is that the holdfast applicator of Figure 14 places the perspective view in the guiding device shown in Figure 6;

Figure 16 is the sectional view of amplification of the embodiment of holdfast applicator of Figure 14;

Figure 17 adheres to the sectional view that applicator is amplified, and an embodiment of the near-end and the driving mechanism of spiral type holdfast is shown;

Figure 18 is the perspective view of amplification of an embodiment of spiral type holdfast shown in Figure 16;

Figure 19 is the zoomed-in view that adheres to applicator, and an embodiment of the Control Component that activates the holdfast applicator is shown;

Figure 20 activates the enlarged drawing that adheres to that applies with the holdfast of implanting graft and blood vessel wall;

The proximal graft thing that Figure 21 illustrates the Fig. 3 that has finished is attached to the enlarged drawing of blood vessel wall with holdfast;

Figure 22 is the perspective view that fully is attached to the graft shown in Figure 4 of blood vessel.

The specific embodiment

Fig. 1 has described in the blood vessel inguide line 12 placesventral aorta hemangioma 11 graft and has provided conduit 10.Fig. 2 is described in the starting stage of laying graft in the blood vessel.Grantingconduit 10 has the movablycover 13 on graft.When the described cover of near-end dilazep,graft 14 expands with the inwall of contact blood vessel.It is expansible voluntarily or the use expansion member that graft can be conceived, such as the expander of air bag or machinery.Continuing graft laying process fully is routed in the blood vessel up to graft.Graft can conceive be straight also can be the branching shape.Fig. 3 illustrates the straight graft of having laid fully 14, and Fig. 4 describes thegraft 15 of the branching of having laid fully.Guide line 12 is used for providing and the location graft, is retained in the blood vessel with sensible holdfast attachment systems.An embodiment of graft support 16 (this Teng Shi support) illustrates in the mode of the broken section of Fig. 4.Described support is the form with simple zigzag pattern, yet the design of support can be conceived the complicated patterns more 17 that relates to as shown in Figure 5.Although a supporting structure in the graft only is shown, in graft, can conceive a plurality of independently supporting structures of adding in Figure 4 and 5.

Fig. 6 has described an embodiment of guidingdevice 18, has in the cavity that places guiding device and extends through thevertical occlusion 19 of distal part of guiding device.Described occlusion has that a cavity makes it can be by the guide line granting.Fig. 7 illustrates guiding device intra-graft in the blood vessel thatguide line 12 has been laid and is positioned.Guiding device has the stabilisingarrangement 20 of merging to help keeping guiding device in endovascular position.In one embodiment, stabilisingarrangement 20 is spring-loaded and is positioned when being used in the occlusion of taking away in the guiding device, consults Fig. 8.Guiding device activates byControl Component 21 as shown in Figure 8.In one embodiment,Control Component 21 is taken turns orlever 22 is a feature with removable, described removable take turns or lever 22 deflects into desirable position to thedistal part top 23 of guidingdevice 18, as shown in Figure 9.The Control Component that the present invention imagines guiding device can mechanically, electrically, hydraulically or pneumatically be activated.Described Control Component has the cavity of break-through so that occlusion and holdfast applicator can be passed through.Figure 10 has described movably another embodiment of the stabilising arrangement ofstrut assemblies 24 of conduct.Movably thelever 25 of strut assemblies on Control Component shown in Figure 11 activates.In two embodiments (Fig. 7 and 10), stabilising arrangement is all at the far-end of guiding device.In another embodiment, stabilising arrangement can be the form that is adjacent to the vertical expandable member of distal part of guiding device, consults Figure 12.In one embodiment, thelever 25 thatexpandable member 26 illustrates on Control Component activates, and consults Figure 13.Yet can also conceive this stabilising arrangement sensation can be by inflation.In all embodiments, stabilising arrangement may be used to stablize guiding elements, no matter be with one heart or off-centre in blood vessel.

In another embodiment of the invention, can using independently, tube cooperates with guiding device with sensible blood vessel.This independently tube can merge the stabilising arrangement that is used in the guiding device top.

Figure 14 describes out an embodiment of holdfast applicator 27.Figure 14 A is the detail drawing of the far-end of holdfast applicator.Figure 15 describes out the holdfast applicator and is positioned in and will the place of holdfast be installed through the cavity of guiding device.

Figure 16 illustrates the sectional view of the amplification ofholdfast applicator 27 and guiding device 18.In an embodiment of holdfast applicator,spiral type holdfast 28 is rotated throughholdfast driver 29 by thedrive rod 30 that is connected to Control Component 31.Drive rod 30 can be with any material manufacture that makes it crooked also can to rotate.Drive rod is connected on theholdfast driver 29, the latter engage spiral holdfast and to carry-over moment.Figure 16 illustrates the coil of the spiral type holdfast 28 that engages withinternal channel 32 in the holdfast applicator.Can conceive, described groove is along the whole length of holdfast or be positioned within the part of its length.Figure 17 is the sectional view of the amplification ofholdfast applicator 27, and an embodiment that engages between the holdfast 28 of holdfast driver and spiral is shown with the cross section of holdfast driver 29.In this embodiment, form the proximal coil of spiral type holdfast to produce thediagonal member 33 of the diameter of crossing over the spiral type holdfast.Similarly the spiral type holdfast is illustrated in United States Patent (USP) 5,964,772; 5,824,008; In 5,582,616 and 6,296,656, its disclosure is all drawn the do reference.

Figure 18 describes an embodiment ofspiral type holdfast 28, anddiagonal member 33 is shown.Figure 19 describes an embodiment ofholdfast applicator 27 in the actuation process of holdfast applicator Control Component.The actuating rotation of drive rod of described Control Component, holdfast driver and spiral type holdfast.This rotation causes thatspiral type holdfast 28 divides a word with a hyphen at the end of a line and enter ingraft 14 and theblood vessel wall 34 in theinternal channel 32 of holdfast applicator, consult Figure 20.The Control Component of holdfast applicator can be conceived and mechanically, electrically, hydraulically or pneumatically be activated.

Figure 21 illustrate thespiral type holdfast 28 finishedgraft 14 attached on the blood vessel wall 34.Can conceive, need provide one or more holdfast graft securely attached on the blood vessel wall.

Figure 22 illustrates near-end and far-end attached to the perspective view of the graft prosthese on the blood vessel wall.The present invention can conceive and be used for carrying out straight graft withgraft 15 branching adhere in the branch blood vessel of aorta and other.

Be appreciated that the composition of the preferred embodiment that this paper illustrates and/or feature can use together or independently, described method and apparatus can be whole or partly be combined or revises simultaneously.Can conceive, guiding device, holdfast applicator and spiral type holdfast can alternately mutual relative orientation, for example skew, twin shafts or the like.And, be to be understood that and can use the not various embodiments outside other processes of explanation of this paper, such as blood vessel wound, arteriotomy, Cardiac valve prosthesis adheres to and adhering to of other prosthese in vivo in vascular system and in general.

More than describe embodiment of the present invention in detail, to propose complete disclosure and cause in order to explain and to illustrate.Those skilled in the art can imagine other in the category of present disclosure and other modification in the spirit.

Claims (11)

1. but be used for being implanted into the device of the prosthese of expanded radially at body cavity, described prosthese contains at least one support, this support can expand and a plurality of holdfast at endoceliac implant site, and this holdfast can be the support anchor on the throne in prosthese is introduced into the zone of described support.

2. the described device of claim 1, wherein said support is elastic, and described support can expand at described implant site to allow described support voluntarily by expanding from intrafascicular approximately release.

3. the described device of claim 1, wherein said support is a malleability, and described support can expand by apply expanded radially power in support.

4. the described device of claim 1, wherein said prosthese contains at least two supports, and described at least two supports can spaced positions expand on described prosthese.

5. the described device of claim 1, but the prosthese of at least three expanded radiallys wherein on described prosthese, contained.

6. the described device of claim 1, wherein said support is crossed over the whole length of described prosthese.

7. the described device of claim 1, wherein said prosthese contain the fiber that covers the described support of at least a portion, and wherein at least some described holdfasts can be introduced into and be introduced into without support through fiber.

8. the described device of claim 1, wherein said prosthese contain the fiber that covers the described support of at least a portion, and wherein at least some described holdfasts can be introduced into above the element of described support.

9. the described device of claim 1, wherein said holdfast contains spiral type and penetrates holdfast.

10. the described device of claim 9, wherein said prosthese contain inwall and the post that can open in the circle spacing on the described prosthese inwall in the single holdfast that is introduced into.

11. the described device of claim 10 wherein contains 2-12 the spiral type holdfast that can be introduced in each zone of settling described holdfast.

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