WO2005079152A2 - Endovascular aortic apparatus and method for delivery and fixation of intravascular devices - Google Patents

Abstract

The present invention relartes to medical technique, more particularly to methods and apparatus for delivery grafts or stent-grafts, and fixation them to the wall of aorta. Endovascular apparatus comprises: a tubular body with an expandable working head on its free end having from four up to eight cartridges, each of them being provided with one basic and at least one standby staples. Apparatus further provided with a control mechanism and means for positioning within an aorta. There is proposed a method for delivery and fixation fo grafts or stent-grafts to the wall of aorta, from insude the latter.

Description

ENDOVASCULARAORTICAPPARATUSAND METHODFORDELIVERYANDFIXATION OF INTRAVASCULARDEVICES

(30) Priority Data: iL 130460 19 Fαbπaay 2004 <i9.02.2004) IL 153442 10 August 2004 (1O.OS.20O4) EL 166204 09 January 2005 (09.01.2005) IL 166317 16 January 2005 (16.01.2005)

BACKGROUND OF THE INVENTION

fOOOl) 1. Field of the Invention

P&02} The present invention relates to medical techniques, in particular,

to apparatus and methods used in less or minimally invasive vascular

surgery using grafts for eliminating occlusion of blood vessels or stent-

grafts for preventing rupture of abdominal aortic aneurysm, as well as to

methods for their delivery, location and fixation. More particularly, the

present invention relates to methods and apparatus for securing

intravascular devices, such as grafts or stent-grafts, to the wall of blood

vessels in direction from inside these vessels to their outer surface. \Wm] 2. Description of Related Art

00 ] Occlusion of great blood vessels results from the formation of

calcic and or adipose deposits on their inner surface, or from

tfoombogenesϊs and causes deterioration of blood supply to implant

organs, such as the heart and liver, which leads to such dangerous

situations for the patient, as infarction or insult.

f OOS} To prevent occlusion of great blood vessels, there are widely

used different methods of imaging of main blood vessels. During

angiography, inside the blood vessel, there Is introduced a guide, and

over the latter a catheter with a balloon at the free end. When deposits of

essential volume or a thrombus is detected inside the blood vessel, the

balloon is inflated by pressure of fluid, so that the corresponding portion

of the vessel expands and opens. In case it turns out to be Insufficient, and

the lumen in the blood vessel remains narrow, there is inserted inside title

corresponding portion of this blood vessel a guide with a balloon,

carrying on its outer surface a stent in compressed state. When fluid is

delivered inside the balloon under pressure, the stent deploys, separates

from the balloon and takes the desired position inside the blood vessel.

All these manipulations are carried out under X-ray control Fixation of

the stent on the walls of a blood vessel is performed via elastic forces of material the stent is made of, the stent is usually shaped as a spring or has

elastic members bearing up against the blood vessel wall or hooking

thereon.

fOOOδ} When the location of a stent for elimination of narrowing or

occlusion of a blood vessel is insufficient, a surgical operation is

performed for suturing a natural or synthetic graft.

f0007} An aortic aneurysm (or its rupture) is a most common form of

arterial aneurysms. It is a very common type of deteriorating disease

affecting the ability of a lumen to conduct fluids and may be life

threatening. The aneurysm is a ballooning of the wall of an artery or aorta

resulting from the weakening of the arterial wall due to disease or other

conditions. Left untreated, the aneurysm will frequently rapture, resulting

in blood loss through the rupture - the condition, which often leads to

death.

[0008] The aorta is the main artery, which supplies blood to the

circulatory system. The aorta arises from the left ventricle of the heart,

passes upwards and bends over behind the heart, and passes down

through the thorax and abdomen. Among other arterial vessels branching

off the aorta along its path, the abdominal aorta supplies two side vessels to the kidneys, the renal arteries. Below the level of the renal arteries, the

abdominal aorta continues to about the level of the fourth lumbar

vertebrae (or the navel), where ϊt divides into iliac arteries. The iliac

arteries, in turn, supply blood to the perinea! area and lower extremities.

[0009} It is common for an aortic aneurysm to occur in the abdominal

region between the renal arteries and the iliac arteries. This portion of the

abdominal aorta is particularly susceptible to weakening, resulting in an

aortic aneurysm. Such an aneurysm is often located near or including the

iliac arteries. An aortic aneurysm larger than about five centimetres in

diameter in tins section of the aorta is ominous. Left untreated, the

aneurysm may rupture, resulting in rapid, and usually fatal,

hemorrhaging. Typically, a surgical procedure is not performed on

aneurysms smaller an five centimetres because no statistical benefit

exists in performing such procedures.

[0010] Aneurysms in the abdominal aorta are associated with a

particularly high mortality rate; accordingly, current medical standards

call for urgent operative repair. Abdominal surgery, however, results in

substantial stress to the body. Mtiiough the mortality rate for a ruptured

aortic aneurysm is extremely hϊgfa, there is also noticeable mortality and

morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal cavity to

the location of the aneurysm to reinforce or replace the diseased section

of the aortic aneurysm. A prosthetic device, typically a synthetic tube

graft, is used for this purpose. The graft serves to exclude the aneurysm

from the circulatory system, thus relieving pressure and stress on the

weakened section of the aortic wall at the aneurysm.

[0011} Beside synthetic grafts, mere are developed and used all over

the world, particularly to prevent the rupture of the aorta wall,

intravascular devices of "stent-graft" type. They are inserted and

positioned similar to stents. Fixation of a stent-graft to an aortic wall is

performed via elastic forces of the material of the stent-graft itself which

usually has springy elements bearing up against the blood vessel wall or

hooking thereon. When the forces of elastic or springy elements of the

stent-graft are insufficient for its fixation in a blood vessel, the stent-graft

may be displaced from the assigned position and moved along the aorta

under the action of blood flow and peristelsic oscillations of the walls of

this blood vessel, and that is quite dangerous for the patient.

[0012} Repair of an aortic aneurysm by surgical means is a major

operative procedure. Substantial morbidity accompanies the procedure,

resulting in a protracted recovery period. Further, the procedure entails a substantial risk of mortality. While surgical intervention may be indicated

and the surgery carries attendant risk, certain patients may not be able to

tolerate the stress of infra-aMominal surgery. It is, therefore, desirable to

reduce the mortality and morbidity associated with iπtra-abdominal

surgical intervention.

[0013} In recent years, the common repair means is to deploy a graft or a

stent-graft within the lumen of the affected aorta artery in the region of

the aneurysm. These methods and devices have been developed to

attempt to treat an aortic arterial aneurysm wimout the attendant risks of

infra-abdominal or open arterial surgical intervention. Among them are

inventions disclosed and claimed in Parσdi, Juan C. et al., WO 010487A1

for Graft Device for Treating Abdominal Aortic

and its patent

family, including U.S. Pat. Nos. 5219355, 5522880, 5571171, 5643208,

56S3452, 5693087, 6102942, EP 461791 Al, EP 809980A3, EP

903118A2, EP 903119A3, EP 903120A3 etc..

[0014} In other ParodFs patents there are disclosed stent-graft designs

having a metal wire frame collapsible to a minimal size sufficient to

insert the stent-graft into the artery through a puncture in its wall and

expandable inside the aorta to a required size under the action of a radial

force, such as a balloon. This frame is covered by a sheath which can contract and expand together with the frame under the action of external

forces. Aforesaid stent-grafts are provided with means for mechanical

fixation to the walls of the aorta or iliac arteries. -Among those means we

find balloon cuffs of a special shape at the stent-graft ends, see WO

010487 Al, U.S. Pat. No. 5219355, various hooks, elements shaped as

scales, spirals and similar elements designed for fixation on the wall of

the aorta or artery, see U.S. Pat. No. 5911733 'Εndovascular Expander of

a Non-migrant Positioning", EP 948945 A2 *Εndovascular Prosthesis

with Fixation Means".

[0015} Migration of grafts and7or stent-grafts from determined positions

concerning walls of aorta or major arteries is still a very actual problem

which increases the risk of surgical procedure with introduction of these

prostheses. In different countries mere are developed various devices and

methods for the fixation of prostheses. As fastener means there are

suggested helical fasteners, see U.S. Pat. 6562051, U.S. Pat. Appl

2003/0135226 Al or spiral holders, see EP 1300121 A2, U.S. Pat. Appl

2003 0093146 Al, and as a means for their delivery and location

devices ϊike^*ΕndovascuIar aneurysm repair system", see WO 03/045283

Al. [0016} There are further known numerous inventions the authors whereof

suggest fastener means made of a shape memory alloy. Among these are

inventions by Howard Tanner, Arnold Miller etc., see WO 01/58364 Al,

U.S. Pats. 5944750, 5972023, WO 02/17797 Al , WO 02/17796 Al, WO

02/19923 Al and U.S. Pat. Appl 2002/0029048 Al and 2003/0105473

AL

[0017} And, at last, fastener means are known produced by "Anson

Medical Ltd", see Britain Pat. GB 2359024A ^Fϊxator for arteries , WO

01/58363 Al and U.S. Pat. Appl 2003 0033006 Al "Device for the

repair of arteries". This device for retaining a graft on an artery

comprises an abutment portion for abutting the graft wall, and two

elongated members extending therefrom. The elongate members are

resiliently biased into a retaining configuration and movable into an axial

configuration to enable the fixator to be conveyed along an artery. The

device comprises at least two wires fabricated from a material which has

a spring or thermal shape memory alloy such as nickel titanium shape

memory alloy such that their unconstrained shape Is a curved T' or

"gull-wing" shape. The wires can be constrained to be parallel, each wire

having two ends, the wires being joined together at or near to one end by

welding, braising or similar means. In other embodiments the device is

made from one wire and has a "gull-wing" shape. [0018} While performing surgical operaϊons using stents, grafts or stent-

grafts, physicians and engineers face the problem of delivering implanted

devices through a comparatively small opening in the artery ( up to 6 - 8

mm in diameter), then t .hrough the artery inside the operated blood vessel,

such as the aorta, and succeeding deployment of the implanted device in

the lumen of this blood vessel The lumen size in the aortic neck area is at

least 20 mm. Hence, the delivery system together with the implanted

device mounted thereon must have, firstly, a comparatively small outer

diameter to pass through mis punch in the artery wall, and, secondly, be

capable of essentially enlarging its cross section at the spot where the

implanted device should be located. For mis purpose the delivery system

is usually provided with an inflatable hydraulic balloon carrying on its

surface the delivered device - stent, graft or stent-graft. At the same time,

there are known entirely mechanical delivery systems, wherein instead a

balloon machanical deployable means are used resembling "Chinese

lanterns", such as "Mechanical stent and graft delivery system"

described by Houser, Russell et al, see U.S. Pat. 6217585 or "Apparatus

and method for dilating a lumen and for inserting an intraluminal graft",

seeHogendϊjk, Michael et al, U.S. Pat. 5713907.

[0019} Similar to the latter is the "Cardiovascular mechanically

expanding catheter" by Bar-Cohen, Yanlv, see U.S. Pat. 5855565. The catheter has a mechanically expanding mechanism on the distal end

thereof for dilating vessels such as arteries and other endoluminal

structures and for the deployment of mfraϊuminal stents. A permeable,

mechanical dilating mechanism includes a pair of expanders which

provide a radial force against the wall of a vessel in response to a pulling

or contracting longitudinal force on the dilating mechanism, for example,

by means of a cable. A set of adjacent quadrates are preferably provided

for promoting uniformity of pressure by the expanders.

[0020} Among mechanical delivery systems, closest to the claimed

invention are methods and devices developed by Marin, Michael and

Marin, Ralph, see U.S. Pats. 5443477, 5507769, 5591196, 5618300,

5695517, 6039749, 6168610, 6575994, as well as WO 95/21593, WO

96/11648 and EP 1290989. By the disclosed method, stent-graft complex

is advanced through each branch of the patient's femoral and iliac

systems. The stent-graft complex includes a segment of prosthetic graft

material attached at each end to a respective stent. The proximal part of

each stent-graft complex Is positioned relative to one other in a common

region of normal aortic tissue on one side of the aneurysm and then

deployed. The distal part of stents is deployed in the lilac arteries.

Additional steps can be taken to ensure mat the internal iliac artery is not

blocked when the distal stents are deployed. [0021} A common drawback of all above mentioned methods and

devices is that they are chiefly intended for delivering implanted devices

inside operated blood vessels. The delivered implanted devices are

provided at their ends with fixation means - stents which are not

incorporated in the structure of delivery devices. Besides, in our opinion,

the fixation of implanted devices must be performed substantially by

elastic force of these stents. We think it is obviously insufficient and

cannot prevent the displacement of implanted devices due to blood Sow

and peristelsic oscillations of blood vessel walls. Besides, the length of

aorta neck does not always allow to locate a stent at this place which

makes conjectural the application of the aforesaid methods and devices.

[0022} We contemplate that delivery systems must have, apart from

means for delivery and deployment of implanted devices, special means

for fixation of implanted devices to blood vessel walls, such as the aorta,

to provide their secure fixation in required places and prevent thereby

displacement of implanted devices via aforesaid forces.

[0023} There are known devices used during surgical operations for

suturing tissues via fixing means, such as clips, see, for example, suturing

instument and clip by Schulken et al, U.S. Pats. 5499990, 5522823 or

surgical staple for tissue by Richard, Thierry, see France Pat. 2746292. [0024} The British company "Anson Medical Ltd" and its specialists,

Anson, Antony et al, see EP 0915678 Bl and WO 00/07506, disclose a

device for retaining a graft on an artery, comprising a first part for

contacting with the graft and a second part for contacting with the artery

when the device is pierced radially through the graft and the arterial wall

This first and second parts are connected by a resilient member, which

biases the first and second parts towards each other into a retaining

configuration such that in use the artery and the graft are retained together

between the first and second parts of the device. The device for graft

fixation is made of a shape memory alloy, and includes in transport

position two lengths of wire arranged in parallel relationship to one

another and fastened together at the middle.To deliver this device to the

location spot there is used a delivery system including an expandable

member for the graft deployment In its fixation area and for pressing the

graft edge to the aorta wall, as well as means for storage and delivery of

the described devices for graft fixation to the spot of their location.

[0025} Suyker, Wlδielmus et al, in U.S. Pat. 6485496 and U.S.

PaiAppl 2003/0055441 disclose a system for making anastomoses

between hollow structures by mechanical means, which is provided with

a device in the shape of an annular or tubular element comprising

cfrcumferentlally provided means, such as pin-shaped elements, for joining the abutting walls of the hollow structures together. There is also

disclosed an applicator for moving this annular or tubular element in

position and activating the joining means thereof, so as to make the

anastomosis.

[0026} 3. The Prior Art

[0027} Parσdi, Juan, in U.S. Pat. 6336933, EP 1308131 Al and U.S. Pat.

Appl 2003/0023248 discloses systems and methods for applying a suture

within a blood vessel lumen. The systems and methods advance within a

blood vessel a catheter tube having a distal region that carries a suture

applicator. The systems and methods operate the suture applicator from a

location external to the blood vessel lumen to apply a suture, having a

spiral shape, to an interior wall of a blood vessel lumen. In U.S. Pat.

6592593 and WO 00/16101, Parodl, Juan et al, disclose an applicator

including a tubular body that is configured for positioning within a

vessel, an expandable portion disposed adjacent the distal end of the

tubular body and deployed to support a prosthetic in contact with an inner

surface of a vessel, and a drive assembly for advancing a fastener into the

prosthetic. A delivery tube may be included that is disposed for

movement within the tubular body, and which defines a channel for

movement of the drive assembly there within. The delivery tube may include an applicator head. The applicator head may include an injection

mount that is disposed for movement relative to a prosthetic.

[0028} Closest to the present invention is "Second generation coil

fastener applϊer with memory ring" by Aranyi, Ernest et al, see U.S. Pat.

Appl 2002/0177862 and WO 00/64357. There is an endo-vascular

fastener applϊer for fastening a vascular graft to a vessel with at least one

fastener. The applicator generally includes a tubular body configured for

positioning within the vessel, and an expandable portion adjacent the

tubular body. A fastener applying head is movabϊy mounted within the

expandable portion. The applicator further includes a handle assembly

mounted on a proximal end of the tubular body. The handle assembly

generally includes a control for releasing the expandable portion,

pivoting, rotating the fastener applying head and for driving the fastener

out of a fastener driving head. Preferably, the applicator also includes a

storage chamber extending from a distal end of the expandable portion,

and containing a plurality of fasteners.

[0029} The known methods and systems for delivery or fixation of grafts

and stent-grafts have, as a rule, different functions, i.e. serve solely either

for dϊlivery and deployment of grafts and stent-grafts or for their fixation

to blood vessel walls. Those few methods and systems that combine these functions, see, for example, Marin, Michael and Marin, Ralph, U.S. Pats.

5443477, 5507769, 5591196, 5618300, 5695517, 6039749, 6168610,

6575994, WO 95/21593, WO 96/11648 and EP 1290989, use for

prostheses fixation stents or similar devices connected to these

prostheses, and these devices do not provide secure fixation of implanted

prostheses to the walls of corresponding blood vessels and the aorta.

[0030} An object of the present invention Is to develop a method and

apparatus system providing simultaneous delivery and secure fixation of

implanted endovascular prostheses, particularly, grafts or stent-grafts, in

corresponding blood vessels.

[0031} Another object of the present invention is to develop a system of

apparatus assembled from a kit of standardized parts (similar to a

construction kit for children) which allows to assemble fast an apparatus

adapted to the anthropometric conditions of a specific patient and

intended for performing a surgical operation to deliver a graft or stent-

graft of a specific type and size and fixate the latter to the walls of a blood

vessel

[0032} A third object of the present invention is to develop a new method

of graft or stent-graft fixation to the walls of blood vessels. SUMMARY OF THE INVENTION

[0033} The subject-matter of the present invention is an endovascular

apparatus used for delivery and fixation to the walls of blood vessels,

substantially the aorta, of endovascular devices, substantially grafts or

stent-grafts. This apparatus is assembled from a kit of standardized

elements. The proposed apparatus comprises a tubular body, expandable

working head with cartridges adapted for location of fastener means, as

well as a control mechanism.

[0034} The tubular body of the claimed apparatus is configured for

positioning inside a blood vessel. This tubular body is rigid in longitudinal

direction and flexible in lateral direction.

[0035] The expandable working head with cartridges for location of

fastener means is disposed near the free ends of said tubular body. This

working head is made expandable to retain a delivered graft or stent-graft

in contact with the inner surface of a blood vessel at the moment of their

mutual fixation. The working head is provided with at least four

cartridges, each for location of at least two fastener means, these

cartridges being incorporated in the structure of this working head. The

cartridges are provided with means for retaining therein fastener mearis, for imparting thereto progressive motion, for shaping the fastener means

while they are extending from these cartridges, as well as for storing and

delivering of standby fastener means.

[0036} The control mechanism of the described apparatus is provided at

least with one first control means and at least with one second control

means. The control mechanism is disposed at the end of tubular body

opposite to the working head and is connected with the expandable

working head via this tubular body and a retaining tube enclosed therein,

which is rigid in longitudinal direction and flexible in lateral direction.

The first control means serves to control the expansion and contraction of

the expandable working head, and the second control means serves to

control the extension of fastener means from each of at least four

cartridges, as well as to control the reloading of each of these cartridges

with at least one standby fastener means.

[0037} The expandable working head contains a first and second bearing

bushes and a pessure bush, arranged in succession one after another

beginning from the free end of this head and in alignment with the tubular

body, as well as an axial rod rigidly connected with the first bearing

bush. The second bearing bush is connected with the body of the control

mechanism via a retaining tube passing via a through axial hole in the pressure bush. The retaining tube Is located within the tubular body and is

concentric thereon.

[0038} In another embodiment of suggested apparatus, the working head

also comprises a first and a second bearing bushes and a press re bush

arranged in succession one after another beginning from the free end of

this head and in alignment with the tubular body, as well as an axial tube

with a balloon disposed between the first and second bearing bushes. The

axial tube is connected with the first bearing bush and passes via through

axial holes in the second bearing bush and in the pressure bush. The

balloon disposed between the first and second bearing bushes serves for

expansion and contraction of the expandable working head. In the next

embodiment of the apparatus the axial tube has two balloons. The first

balloon disposed between the first and second bearing bushes serves for

expansion and contraction of the expandable working head. The second

balloon disposed at the free end of this axial tube outside the expandable

working head serves to cut off the lumen of a blood vessel at the moment

of suturing a graft or stent-graft. [0039} The expandable working head is provided at least with four

cartridges pivotally secured by one there ends on said second bearing

bush and pivotally connected by their other ends, with bearing levers

which are pivotally mounted on the first bearing bush. In another

embodiments the expandable working head Is provided at least with six

or with eight cartridges pivotally secured by one there ends on said

second bearing bush and pivotally connected by their other ends with

bearing levers which are pivotally mounted on the first bearing bush. The

expandable working head is provided with means for securing a delivered

graft or stent-graft disposed on the bearing levers near their pivotal

connections with corresponding cartridges.

[0040] Each of the cartridges contains at least one basic fastener means,

substantially U-shaped staple, disposed In this cartridge substantially

along its longitudinal axis, with free pointed ends facing the means for

shaping. The U-shaped staple is disposed in the cartridge so as to extend

progressively therefrom and be shaped during this extension, and the

means for shaping is located in each cartridge near the point of its pivotal

connection with a corresponding bearing lever. Besides, each cartridge

contains a means for retaining therein at least one fastener means,

substantially U-shaped staple, mis means for retaining being disposed

along the cartridge and containing a sliding lid. [0041} And at last, each of the cartridges includes at least one means for

imparting progressive motion to the fastener means, substantially U-

shaped staple. This means contains a flexible pusher, rigid in longitudinal

direction and flexible in lateral direction. All the flexible pushers are

connected by one their end with the pressure bush of the expandable

working head and disposed under the sliding lids of corresponding

cartridges to reciprocate in the clearance between the bottom of a

corresponding cartridge and its sliding lid.

[0042} Each of the cartridges has a bottom and a sliding lid and contains

a means for storing at least one standby fastener means, substantially a

standby U-shaped staple. This means for storing contains a slot in the

cartridge bottom to locate at least one spring-loaded standby U-shaped

staple which is disposed in this slot substantially along the longitudinal

axis of the cartridge, with free pointed ends facing the means for shaping.

At least one standby U-shaped staple is located in the slot of this cartridge

bottom, substantially under its flexible pusher to extend from this slot

under the action of a spring and at partial removal of the flexible pusher

from the clearance between the bottom of this cartridge and its sliding lid. [0043] In another version of the cartridge the slot in its bottom is a

through one, and the standby U-shaped staple is disposed in this slot

immediately under the flexible pusher and is spring-loaded from the

opposite side.

[00 ] Each of the cartridges of the endovascular apparatus contains at

least one basic and at least one standby fastener means, substantially a U-

shaped staple. All these staples are made from one of the materials of the

group including stainless steel, titanium and shape memory alloys.

[0045} AH cartridges of the working head are evenly arranged about the

longitudinal axis of this head and pivotally connected by their first ends

with its second bearing bush, and by their second ends pivotally

connected with bearing levers which are pivotally mounted on the first

bearing bush. All the cartrudges together with their sliding lids, flexible

pushers and bearing levers are identical and interchangeable.

[0046] The apparatus is additionally provided with means for axial and

radial positioning at an assigned point of the operated blood vessel. The

means for axial positioning contains a part of the axial tube with the

second balloon at the free end projecting from the expandable working

head, the axial tube and the secnd balloon having a measuring scale on their outer surface. The means for radial precision positioning of the

working head contains markers - X-ray contrast marks evenly applied on

the outer surface of cartridges near the points of their connection with

bearing levers.

[0047] in the proposed apparatus the axial tube Is connected via the first

connecting means with the first control means of the control mechanism.

The pressure bush is operatlvely connected via second connecting means

with the second control means of this control mechanism. The second

bearing bush is connected with the control mechanism body via a

retaining tube passing via a through axial hole of the pressure bush. The

first connecting means, retaining tube and second connecting means are

enclosed in the tubular body concentrically with one another and with

this tubular body. The first connecing means may contains a hydraulic

line, and the second connecting means may be mechanic or hydraulic.

[0048} The control mechanism at least with one first control means and

at least with one second control means may be supplied wih detachable

additional sections to locate therein supplementary control means.

[0049] Each of the cartridges of the proposed apparatus has a body with

a bottom provided with a recess to locate at least one basic fastener means, substantially a U-shaped staple, and a through slot to locate at

least one standby fastener means, substantially a standby spring-loaded

U-shaped staple. Besides, this cartridge body has slots for mounting a

sliding lid, as well as a longitudinal duct to locate at least one flexible

pusher. The basic U-shaped staple is disposed in its recess in frictional

contact with the sliding lid which prevents it from falling out of this

recess. The standby spring-loaded U-shaped staple is disposed in its

through slot in frictional contact with the flexible pusher which prevents

it from extension from this through slot until this flexible pusher is partly

removed.

[0050} Each cartridge of the working head has a body with a bottom

provided with a recess to locate at least one basic fastener means,

substantially U-shaped staple. The recess in this cartridge body is

symmetric about the longitudinal axis of this cartridge and parallel with

its outer surface. The cartridge is further provided with a means for

shaping the U-shaped staple during its extension from the recess. This

means contains a curvilinear guiding surface connecting the bottom of

this recess for the U-shaped staple with the cartridge outer surface. This

curvilinear guiding surface Is provided with shaping grooves diverging at

an acute angle from one another and the longitudinal axis of this

cartridge. [0051] Each U-shaped staple has pointed free ends and is disposed in the

body recess of a corresponding cartridge in such a way that its pointed

ends face the shaping grooves on this curvilinear guiding surface of this

cartridge. This provides helical oppositely directed curling of pointed

ends of a corresponding U-shaped staple during its movement over the

body recess and shaping grooves of the curvilinear guiding surface of this

cartridge.

[0052] Each cartridge of the working head is shaped substantially as a

polyhedral prism with skewed lateral faces inclined at an acute angle to

one another. The vertex of this acute angle is disposed on the longitudinal

axis of the expandable working head. All the cartridges are provided with

means for connection with this expandable working head. These means

substantially contain arms with holes which project from both bases of a

corr-esponding polyhedral prism ά -are --sfceg^aϊ with this polyhedral

prism.

[0053} AH mis bearing levers of the expandable working head are

provided with means for securing a delivered graft or stent-graft shaped

substantially as radial tongues located on one of the ends of these bering

levers, near pivotal connections with the cartridges. [0054} Another subject matter of the present invention is a method for

delivery and fixation of a graft or stent-graft to the wall of a blood vessel

from inside the latter comprising several successive steps.

[0055] At the first step the graft or stent-graft is prepared for delivery,

mounted and secured on the surface of the expandable working head of

the apparatus for delivery and fixation, as well as crimped to an assigned

outer diameter.

[0056] At the second step the endovascular apparatus for delivery is

brought into operative position, inserted into a corresponding blood

vessel, the expandable working head is brought to the securing area and

precision axial and radial positioning of the apparatus in a given point of

the aorta is performed via a measuring scale on the surface of this axial

tube and balloon and via markers - X-ray contrast marks. Then the

working head is deployed in such a way that the delivered graft or stent-

graft is in contact with the inner surface of the blood vessel at the moment

of their mutual fixation, and the cartridges of this expandable working

head are located near corresponding suturing points. [0057} Then U-stapIes are set in motion, which is achieved via means

for imparting pogressive motion to these staples, said means, in their turn,

being actuated by the pressure bush, second connecting means and

second control means which are associated with these means. As a result,

pointed ends of each of the U-shaped staples enter the shaping grooves of

curvilinear guiding surface of a corresponding detachable cartridge, are

curled therein diverging in opposite directions from one another, pierce

the graft or stent-graft wall and surrounding blood vessel wall and return

again over a spiral to this curvilinear guiding surface, repeating this

rotation ϊf permitted by the given length of staples. As a result, the graft

or stent-graft wall is sutured by wire spirals formed from U-shaped

staples to a corresponding portion of the blood vessel, and the U-shaped

stapled themselves entirely emerge from the recess of corresponding

cartridges and are released from these cartridges.

[0058] Thereupon the cartridges are reloaded with standby U-shaped

staples which is accomplished via partial removal of flexible pushers

activated, in their turn, via pressure bush, second connecting means and

second control means associated therewith. As a result, each of the

spring-loaded standby U-shaped staples emerge from the through slot of a

corresponding cartridge, and then at reverse movement of a

corresponding flexible pusher moves under its action into the recess where the basic U-shaped staple was located before. Thereby the

endovasular apparatus is made ready for repeated prosthesis suturing.

[0059] Then, if repeated sutarfng is necessary, standby U-shaped staples

are set in motion. This is performed via flexible pushers actuated, in their

turn, via pressure bush, second connecting means and second control

means associated .-herewith, much as the basic U-shaped staples were

previously extended. As a result, pointed ends of each of the standby U-

shaped staples enter shaping grooves of the curvilinear guiding surface of

a corresponding cartridge, are curled therein, diverging in opposite

directions from one another, pierce the graft or stent-graft wall and

surrounding blood vessel wall and return again over a spiral to this

curvilinear guiding surface, repeating this rotation if permitted by the

given length of staples. As a result, the graft or stent-graft wall Is

repeatedly sutured by wire spirals formed from standby U-shaped staples

to a corresponding portion of the blood vessel wall, and the standby U-

shaped staples themselves entirely emerge from recesses of

corresponding cartridges and are released from these cartridges. [0060] At last, at the final step, the delivered and sutured graft or stent-

graft is detached from the apparatus for delivery and fixation, this

apparatus is set in inoperative position and removed from the graft or

stent-graft and from the blood vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The invention will now be described in conjunction with the

following drawings In which like reference numerals designate like

elements and wherein:

[0062] FIG. 1 shows a general view of the first embodiment of the

propo-sed apparatus;

[00631 FIG.2 shows a general view of the proposed apparatus without

working head;

[0064] FIG. 3 shows a longitudinal section of the control mechanism of

the proposed apparatus;

[0065] FIG. 4 shows a general view of a 4-cartridge working head of the

first embodiment of the proposed apparatus not completely expanded; [0066] FIG. 5 shows a general view of a 6-cartridge working head of the

second embodiment of the proposed apparatus in contracted state;

[0067] FIG. 6 - 8 show general views of the third embodiment of the

proposed apparatus, including FIG. 6, 8 - with a balloon and FIG. 7 -

with a guide;

[0068] FIG. 9 - 11 show general views of the fourth embodiment of the

proposed apparatus, including FIG. 9, 10 - with a second balloon and

FIG. 11 - without this balloon;

[0069] FIG. 12 shows the general view of an 8-cartridge working head of

the fourth embodiment of the proposed apparatus in contracted position;

[0070] FIG. 13 shows a general view of the first supporting bush of the

working head;

[0071] FIG. 14 shows the general view of a cartridge with a sliding lid;

[0072] FIG. 15 shows the general view of a cartridge with a through slot

in its bottom: [0073] FIG. 16 shows the general view of a cartridge on the side of its

bottom and through slots;

[0074] FIG. 17, 18 show the views of a cartridge with diagrams of

location of the basic and standby U-shaped staples;

[0075] FIG. 19 shows a diagram of operation of the first and second

embodiments of the proposed apparatus;

[0076] FIG. 20 shows a diagram of operation of the third and fourth

embodiments of the proposed apparatus.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0077] The preferred embodiments of the present invention are described

below. The inventors of the present subject matter contemplate that the

embodiments described herein are capable of use in the repair of other

vessels and in other procedures. Thus, it is intended that the present

invention cover the modifications and variations of the invention,

provided they come within the scope of the appended claims and their

equivalents. [0078] The most preferred embodiments of an apparatus system,

according to the present invention, are shown in drawing figures 1 - 20.

[0079] An apparatus 1 (FΪG.1) for delivery and fixation to the walls of

blood vessels, substantially the aorta, of intravascular devices, such as

grafts or stent-grafts comprises tubular body 3, expandable working head

5 with cartridges 7 for location of fastener means and control mechanism

9.

[0080] Tubular body 3 of apparatus 1 (FIG. 1, 12) is configured for

precision positioning inside a blood vessel, substantially the aorta. This

tubular body 3 is rigid in longitudinal direction and flexible in lateral

direction. As shown in more detail in the drawing (FIG. 2), tubular body

3 may contain several tubes, for example tubes 11, 13, 15, 17, 19 rigid in

longitudinal direction and flexible in lateral direction, which are arranged

concentrically within one another. Tubular body 3 includes outer tube 11,

pressure tube 19, retaining tube 17 to fix the position of working head 5

relative to the control mechamsm 9 of apparaus 1, as well as two tubes 13

and 15 arranged concentrically with one another and serving for delivery

of working fluid to corresponding balloons (FIG. 2). Tubes 13 and 15

may be replaced by one tube with two parallel ducts not connected with one another. Tube 15 also serves as a means for axial positioning of

apparatus 1 (FIG. 12).

[0081] Working head 5 (FIG. 1, 4 - 12) is located near the free end of

tubular body 3 and is expandable (FIG. 4) to retain a delivered

mtravascu r device in contact with the inner surface of a blood vessel, in

this case the aorta, at the moment of their mutual fixation. Working head

5 is provided at least with four and up to eight cartridges 7 adapted for

location of fastener means - U-shaped staples 21 (FIG. 14 - 18).

Cartridges 7 are incorporated in the construction of working head 5 and

provided with means for retaining therein fastener means, for imparting

thereto progressive motion, for shaping the fastener means during their

extension from these cartridges, as well as for storage and delivery of

standby fastener means. AH these means are shown in more detail

hereinbelow.

[0082] Control mechanism 9 (FIG. 2, 3, 6, 7, 9 - 11) is disposed at the

end of tubular body 3 opposite to working head 5 and connected with

expandable working head 5 via this tubular body 3 and retaining tube 17

enclosed therein, rigid In longitudinal direction and flexible in lateral

direction. Control mechanism 9 of apparatus 1 has a body 23 with a

detachable lid 25 and fixed handle 27 (FIG. 3, 4, 5). In the embodiments shown in FIG. 2, 3 It Is provided at least with one first control means -

turning head 29 and at least with one second control means - pressure

handle 31. First control means - turning head 29 serves to control the

expansion and contraction of the expandable working head 5, and the

second control means - pressure handle 31 serves to control the extension

of fastener means - U-shaped staples 21 from cartridges 7, as well as to

control the reloading of each of the cartridges 7 at least with one standby

fastener means - standby U-shaped staple 21. Pressure handle 31 (FIG.

3) Is pivotally mounted in body 23 via pin 33 and Is pivotally secured to

slider 35 located in body 23 to reciprocate along guides 37 specially

provided in body 23. Swing lock 39 in Its operative position limits the

reverse motion of slider 37 (FIG. 3) in a position not requiring the

reloading of cartridges 7 with standby U-shaped staples 21, and return

spring 41 located between pressure handle 31 and fixed handle 27 (FIG.

3) provides return movement of pressure handle 31. If necessary, control

mechamsm 9 may be provided with detachable additional sections for

receiving therein additional control means (not shown in the drawings).

Threaded rod 43 Is provided with an arrow 45 indicating the level of

deployment of expandable working head 5. [0083] Working head 5 according the first embodiment of the proposed

apparatus 1 (FIG. 4) contains a first supporting bush 47 and a second

supporting bush 49, as well as a pressure bush 51., All these bushes 47,

49, 51 are disposed in succession one after another coaxiaUy with tubular

body 3 (FIG. 4, 5). Working head 5 also includes axial rod 53 rigidly

connected with first supporting bush 47 and passing via through axial

holes in second supporting bush 49 and pressure bush 51. In this

embodiment of the working head 5, axial rod 53 is operatively connected

via tube 13, rigid in longitudinal direction and flexible in lateral direction,

with the first control means of control mechanism 9. Second axial bush

49 is connected with the body of control mechanism 9 via retaining tube

17 passing via the through axial hole of pressure bush 51, this tube 13 and

retaining tube 17 being located within tubular body 3, concentrically

thereon and on one another (FIG. 2). Cartridges 7 of working head 5 are

pivotaUy mounted by one their ends on the second supporting bush 49,

and by other their ends pivotaUy connected with supporting levers 55

pivotally mounted on first supporting bush 47 (FIG. 4). All flexible

pushers 57 are connected via one its end with pressure bush 51 of

expandable working head 5 and located around supporting bush 49. [0084] Supporting levers 55 of expandable working head 5 are provided

with means for securing a delivered graft or stent-graft shaped

substantially as radial tongues 59 disposed at one, of the ends of these

supporting levers 55, near the pivotal connections with cartridges 7 (FIG.

4).

[0085] All four cartridges 7 of working head 5 are evenly arranged about

the longitudinal axis of this head 5 and pivotaUy connected by one their

ends with its second supporting bush 49, and by their other ends pivotaUy

connected with supporting levers 55 pivotaUy mounted on first

supporting 47 (FIG. 4). AU cartridges 7 together with their sUding s 61,

flexible pushers 57 and supporting levers 55 are identical and

interchangeable.

[0086] FIG. 5 shows the second embodiment of the proposed

endovascular apparatus, wherein working head 5 has six cartridges 7

evenly arranged about its longitudinal axis and pivotaUy connected by

one their ends with its second supporting bush 49. Cartridges 7 are

pivotaUy connected by other their ends with supporting levers 55 which

are pivotally mounted on first supporting bush 47 (FIG. 5). AU cartridges

7 together with their sliding lids 61, flexible pushers 57 and supporting

levers 55 are also identical and interchangeable. [0087] FIGS. 6 - 8 shows the third embodiment of the proposed

apparatus. Tubular body 3 and expandable working head 5 of the

apparatus are provided with means for axial and radial precision

positioning of the endovascular apparatus at a given point of the operated

blood vessel (FIG. 8). The means for axial precision positioning may

contain, according to the first embodiment of the apparatus, a wire guide

63 (FIG. 7) with a measurement scale on its outer surface located within

the axial ducts of tubular body 3 and expandable working head 5.

According to the second embodiment, the means for axial precision

positioning may as weU contain a flexible tube 65 with a baUoon 67 at the

free end and a measurement scale on the outer surface of tube 65. In this

case tube 65 is located within axial ducts of tubular body 3 and

expandable working head 5 in such a way that its part with baUoon 67 at

the free end projects from expandable working head 5 in alignment with

the latter (FIG. 6, 7). Guide 63 or tube 65 passes aU the way through axial

ducts of apparatus 1, so that, for instance, the means for applying pressure

to baUoon 67 - adapter 69 is disposed on the opposite side of control

mechanism 9 of apparatus 1 (FIG. 6). The means for radial precision

positioning of the working head contains markers - X-ray contrast marks

71 evenly applied on the outer surface of cartridges 7 near the spots of

their connection with supporting levers (FIG. 8). [0088] Control mechanism 9 (FIG. 6, 7) according to this third

embodiment of the proposed apparatus 1 is also located at the end of

tubular body 3 opposite to working head 5. Control mechanism 9 of

apparatus 1 has a body 23 with a detachable Ud 25 and fixed handle 27. In

embodiments shown in the drawings (FIG. 6, 7), it is provided at least

with one first control means - pivotal head 29 and at least one second

control means - pressure handle 31. The first control means - pivotal

head 29 serves for controUing the expansion or contraction of expandable

working head 5, and the second control means - pressure handle 31

serves for controUing the extension of fastener means - U- shaped staples

21 from cartridges 7, as weU as for controUing the reloading of each of

the cartridges 7 at least with one standby fastener means - U-shaped

staple 21. If necessary, control mechanism 9 may be provided with

detachable supplementary sections for location therein of additional

fastener means (not shown in the drawings). Pressure handle 31 is

pivotally mounted in body 23 via a pin 33.

[0089] FIG. 8 shows the third embodiment of the proposed endovascular

apparatus wherein working head 5 has eight cartridges 7 evenly arranged

about its longitudinal axis and pivotally connected by one their ends with

its second supporting bush 49. Cartridges 7 are pivotaUy connected by

their other ends with supporting levers 55 which are pivotaUy mounted on first supporing bush 47 (FIG. 8). In this case aU cartridges 7 together with

their sUding Uds 61, flexible pushers 57 and supporting levers 55 are

identical and interchangeable.

[0090] Working head 5 (FIG. 9, 10 - 12) according to the fourth

embodiment of the proposed apparatus is located near the free end of

tubular body 3 and is expandable (FIG. 6) to retain a deUvered

intravascular device in contact with the inner surface of a blood vessel, in

this case the aorta, at the moment of their mutual fixation. Working head

5 is provided with eight cartridges 7 adapted for location of fastener

means 21 (FIG. 9, 12) AU cartridges 7 being incorporated in the

construction of working head 5 and provided with means for retaining

therein fastener means, for imparting thereto progressive motion, for

shaping the fastener means during their extension from these cartridges,

as well as for storage and delivery of standby fastener means. AU these

means are shown in more detail hereinbelow.

[0091] Control mechamsm 9 (FIG. 10, 11) is disposed at the end of

tubular body 3 opposite to working head 5 and connected with

expandable working head 5 via this tubular body 3 and retaining tube 17

enclosed therein, rigid in longitudinal direction and flexible in lateral direction. Control mechanism 9 of apparatus 1 has a body 23 with a

detachable Ud 25 and fixed handle 27 (FIG. 10, 11). In the fourth

embodiment shown in FIG. 9 - 11 it is provided at least with one first

control means - τnrning head 29 to operate working head 5 and at least

with one second control means - pressure handle 31. First control means

- turning head 29 serves to control fluid deUvery to the baUoons, and the

second control means - pressure handle 31 serves to control the extension

of fastener means - U-shaped staples 21 from cartridges 7, as well as to

control the reloading of each of the cartridges 7 at least with one standby

fastener means - standby U-shaped staple 21. If necessary, control

mechanism 9 may be provided with additional sections to locate therein

the supplementary control means (not shown in the drawings). Pressure

handle 31 is pivotaUy mounted in body 23 via pin 33 and is pivotaUy

secured to sUder 35 located in body 23 to reciprocate along guides 37

specially provided in body 23. Swing lock 39 in its operative position

limits the reverse motion of slider 35 (FIG. 3) in a position not requiring

the reloading of cartridges 7 with standby U- shaped staples 21, and

return spring 41 located between pressure handle 31 and fixed handle 27

(FIG. 3) provides reverse motion of pressure handle 31. Turning head 29

in this embodiment is connected with the rod of hydrauUc control valve

(not shown) and serves to control the dehvery of working fluid via tube

15 to the first baUoon 73, via tube 13 to second baUoon 75 or for shutting both tubes 15 and 13 (FIG. 10 - 12). Tube 15 passes via axial ducts of

apparatus 1 aU the way through, so that the means for applying pressure

to balloon 75 - adapter 77 is disposed on the opposite side of control

mechanism 9 of apparatus 1 (FIG. 10).

[0092] Tubular body 3 and expandable working head 5 of the apparatus

are provided with a means for axial positioning containing a flexible tube

15 with balloon 73 at its free end and a measuring scale on the outer

surface of tube 15. Tube 15 is disposed inside the axial ducts of tubular

body 3 and expandable working head 5 in such a way that its part with

baUoon 73 at the free end projects from expandable working head 5 in

alignment with the latter (FIG. 1, 2). The means for radial precision

positioning of the working head contains markers- X-ray contrast marks

71 evenly applied on the outer surface of cartridges 7 near the points of

their connection with bearing levers 55 (FIG. 6 - 8).

[0093] Tubular body 3 encloses the first connecting means - tubes 13

and 15 for connection of the first control means - pivoting head 29 of

hydraulic control valve with balloons, as weU as the second connecting

means for operative connection of the second control means - pressure

handle 31 with the means for imparting progressive movement at least to

one fastener means-staples 21. The first and second connecting means are arranged concentrically with body 3 and with one another. The second

connecting means may be mechanic or hydrauUc. In the described

apparatus embodiment the second connecting means, is a pressure tube 19

which is mounted by one its end on slider 35 and by the other end-on

pressure bush 51 (FIG. 3, 12) to reciprocate along the outer surface of

retaining tube 17. Retaining tube 17 is secured by one its end on body 23,

and by the other end - on second bearing bush 49 (FIG. 3, 12).

[0094] FIG. 9 -12 show an embodiment of apparatus 1 wherein working

head 5 has two balloons. Expandable working head 5 (FIG. 12) contains a

first and second bearing bushes, 47, 49 respectively, and a pressure bush

51 arranged in succession one after another beginning from the free end

of this head 5 and in aUgnment with tubular body 3, as weU as an axial

tube 13 with baUoon 75 disposed between the first and second bearing

bushes 47 and 49. Axial tube 13 is connected with first bearing bush 47

and passes via through axial holes in second bearing bush 49 and in

pressure bush 51 (FIG. 12). Balloon 75 disposed between first and second

bearing bushes 47 and 49 serves for expansion and contraction of

expandable working head 5. Second balloon 73 disposed at the free end

of axial tube 15, outside expandable working head 5, serves for shutting

the blood vessel lumen at the moment of suturing a graft or stent-graft. [0095] Expandable working head 5 (FIG. 9) is provided with eight

cartridges 7. Cartridges 7 of working head 5 are pivotaUy mounted by one

their ends on second bearing bush 49, and by their other ends pivotally

connected with bearing levers 55 which are pivotally mounted on first

bearing bush 47. Expandable working head 5 is also provided with means

for securing a dehvered graft or stent-graft - radial tongues 59 disposed

on bearing levers 55 near their pivotal connections with corresponding

cartridges 7.

[0096] Each of the cartridges 7 of aU embodiments of the working head 5

contains at least one basic fastener means, substantiaUy U-shaped staple

21, disposed in this cartridge 7 substantiaUy along its longitudinal axis,

with free pointed ends 79 facing the means for shaping - curvilinear

guiding surface 91 (FIG. 14). U-shaped staple 21 is disposed in cartridge

7 to extend progressively therefrom and be shaped during this extension,

and the means for shaping - curvilinear guiding surface 91 is located in

each cartridge 7 near the spot of its pivotal connection with a

corresponding bearing lever 55 (FIG. 14 - 18). Besides, each of the

cartridges 7 contains a means for retaining therein a fastener means,

substantiaUy U-shaped staple 21, this means for retaining being disposed

along cartridge 7 and contains substantiaUy a sUding Ud 61 with a hole

for its opening 81. [0097] At last, each cartridge 7 includes at least one means for imparting

progressive motion to the fastener means, substantiaUy U-shaped staple

21 (FIG. 14 - 18). This means contains a flexible pusher 57, rigid in

longitudinal direction and flexible in lateral direction. Each flexible

pusher 57 is connected by one its end with pressure bush 51 of

expandable working head 5 and disposed under sUding Ud 61 of a

corresponding cartridge 7 to reciprocate in the clearance between the

bottom of corresponding cartridge 7 and its sUding Ud 61. All cartridges

7 together with their sliding Uds 61, flexible pushers 57 and bearing

levers 55 are identical and interchangeable.

[0098] The body of each cartridge 7 has a recess 83 for the location of

U- shaped staple 21, slots 85 for mounting sliding lid 61, as weU as a

longitudinal duct 87 for location of flexible pusher 57 (FIG. 14). U-

shaped staple 21 is disposed in recess 83 in frictional contact with sUding

Ud 61 which prevents it from faUing from this recess 83. Recess 83 in the

body of cartridge 7 is symmetric about the longitudinal axis of this

cartridge 7 and parallel with its outer surface 89 (FIG. 14, 15). The means

for shaping U-shaped staple 21 contains a curvilinear guiding surface 91

which connects the bottom of recess 83 for U-shaped staple 21 with outer

surface 89 of cartridge 7. Curvilinear guiding surface 91 has shaping grooves 93 diverging at an acute angle from one another and from the

longitudinal axis of cartridge 7 (FIG. 11, 14).

[0099] Pointed free ends 79 of U-shaped staples 21 are disposed in

recesses 83 of the bodies of corresponding cartridges 7 in such a way that

they face corresponding shaping grooves 93 on curvilinear guiding

surface 91 of these cartridges 7 (FIG.14). This provides heUcal oppositely

directed curling of pointed ends 79 of corresponding U-shaped staples 21

during their movement over recess 83 of the body and shaping grooves

93 of curvilinear guiding surface 91 of a corresponding cartridge 7.

[0100] Each cartridge 7 has a bottom 95, sUding Ud 61 with a hole 81

(FIG. 14 - 18) and comprises a means for storing at least one standby

fastener means, substantially a standby U-shaped staple 21. This means

for storing is a slot 97 in bottom 95 of cartridge 7 wherein there is located

at least one spring-loaded standby U-shaped staple 21. Staple 21 is

disposed in slot 97 (FIG. 17, 18) substantiaUy along the longituinal axis

of cartridge 7, with free pointed ends 79 facing the means for shaping 91.

At least one standby U-shaped staple 21 is located in slot 97 of bottom 95

of cartridge 7 substantiaUy under its flexible pusher 57 to extend from

this slot 97 under the action of spring 99 and at partial removal of flexible

pusher 57 from the clearance between bottom 95 of cartridge 7 and its sliding lid 61. FIG. 17 shows an embodiment of cartridge 7 wherein slot

97 in its bottom 95 is a through one, and standby U-shaped staple 21 is

disposed in this slot immediately under the flexible pusher and loaded

from the other side by spring 99 secured in the bottom recess of cartridge

7 via bulges 101 speciaUy provided for this purpose (FIG.16).

[0101] Each cartridge 7 of endovascular apparatus 1 contains at least one

basic and at least one standby fastener means, substantiaUy U-shaped

staples 21. AU these staples 21 are fabricated from one of the materials of

a group including stainless steel, titanium and shape memory alloys.

[0102] Each cartridge 7 of working head 5 is shaped substantiaUy as a

polyhedral prism with two skewed side faces 103 inclined at an acute

angle to one another (FIG. 14, 15, 16). The vertex of this acute angle is

located on the longitudinal axis of expandable working head 5. AU

cartridges 7 are provided with means for connection with expandable

working head 5. These means are substantiaUy shaped as arms 105 with

holes 107 projecting from both bases of a corresponding polyhedral prism

and integral with this polyhedral prism.

[0103] Each cartridge 7 of working head 5 is pivotaUy attached by one

its end to arm 105 on second bearing bush 49, and by the other end with its arm 105 pivotaUy connected with bearing lever 55 which is pivotally

mounted on first bearing bush 47 (FIG. 4, 5, 8, 12). Each flexible pusher

57 is connected by one its end with pressure bush 51 of expandable

working head 5 and disposed about second bearing bush 49. Expandable

working head 5 is provided with elements for pivotal mounting of

cartridges 7 (FIG. 13). These may be, for instance, fitting rings wheron

cartridges 7 are slipped by holes 107 of arms 105 (FIG. 14 - 18). These

rings are tightly set in special grooves on the end face of second bearing

bush 49 (FIG. 13). Arms 105 of cartridges 7 are located in slots on the

same end face speciaUy provided for this purpose and may rotate in these

slots about a corresponding fitting ring as about a pivot. Bearing levers 55

are pivotally mounted on first bearing bush 47 likewise. A fitting ring

with bearing levers 55 sUpped thereon is tightly set in special grooves 109

on end face 111 of first bearing bush 47 (FIG. 13). Arms 105 of bearing

levers 55 are located in slots 113 speciaUy provided for this purpose on

the same end face 111 and may rotate in these slots 113 about a

corresponding fitting ring as about a pivot. Axial hole 115 in first bearing

bush 55 serves for passing axial tube 15 through this bush 47 (FIG. 13). [0104] The proposed endovascular apparatus 1 operates according to a

method for delivery and fixation of a graft or stent-graft to the waU of a

blood vessel, substantiaUy the aorta, from inside the latter. This method is

another subject matter of the present invention and comprises several

successive steps.

[0105] At the first stage graft or stent-graft 201 is prepared for deUvery,

mounted and secured on the surface of expandable working head 5 of

endovascular apparatus 1 for deUvery by fixing the prosthesis end on

radial tongues 59 of bearing levers 55, as weU as crimped to an assigned

outer diameter.

[0106] At the second step endovascular apparatus 1 for delivery is

brought into operative position, inserted into a corresponding blood

vessel, in this case aorta 203 (FIG. 19), expandable working head 5 is

brought to the securing area and positioned in axial and radial directions

(FIG. 19). This may be performed for instance via a means for axial

positioning containing a flexible tube 15 with balloon 73 at the free end

and a measuring scale on the outer surface of tube 15. Tube 15 with

baUoon 73 at the free end projects from expandable working head 5 in

aUgnment with the latter (FIG. 20) and balloon 73 cuts off aorta 203

above the renal arteries during prosthesis sutnring. The means for radial precision positioning of working head 5 containing markers - X-ray

contrast marks 71 evenly appUed on the outer surface of cartridges 7 near

the points of their connections with bearing levers 55 (FIG. 4, 9) aUow to

position working head 5 by the operation angle. Then working head 5 is

deployed in such a way that the deUvered graft or stent-graft 201 gets in

contact with the inner surface of the blood vessel - aorta 203 at the

moment of their mutual fixation, and cartridges 7 of this expandable

working head 5 are located near corresponding suturing points. AU this is

made under X-ray control.

[0107] Working head 5 deploys as follows (FIG. 20). When this head 5

reaches the assigned securing area, the surgeon turns pivoting head 29 of

control mechanism 9 to deUver working fluid to baUoon 75 inflating

thereby this baUoon 75. As a result, first bearing bush 47 starts moving

towards second bearing bush 49, so that cartridges 7 and bearing levers

55 turn in their pivotal connections and extend in radial direction causing

an expansion of working head 5. Owing to this the prosthesis - graft or

stent-graft 201 delivered by apparatus 1 is stretched near its end by

expandable working head 5, pressed by its edge against the inner surface

of a corresponding blood vesssel, in this case aorta 203, and then

additionaUy stretched a little more together with aorta 203 until the latter

is fully srtetched in the area of its future connection with this prosthesis (FIG.20). The surgeon controls therewith the extent of expansion of

working head 5 from visual information obtained from an X-ray monitor

(not shown in the drawings). If necessary, the sfretching of aorta 203 and

prosthesis 201 may be somewhat reduced by turning pivoting head 29 in

reverse direction.

[0108] Then, by turning pressure handle 31, U- shaped staples 21 are set

in motion. This is accompUshed via means for imparting progressive

motion to these staples, that is, flexible pushers 57 actuated, in their turn,

by pressure bush 51 and second connecting means - pressure tube 19

which are associated with these pushers. As a result, pointed ends 79 of

each of the U-shaped staples 21 enter shaping grooves 93 of curvilinear

guiding surface 91 of a corresponding detachable cartridge 7, are curled

therein, diverging in opposite directions from one another, pierce the wall

of graft or stent-graft 201 and surrounding waU of the blood vessel - aorta

203 and return again over a spiral to said curvilinear guiding surface 91,

repeating this rotation if permitted by the assigned length of staples 21.

As a result, the waU of graft or stent-graft 201 gets sutured by wire spirals

formed from U-shaped staples 21 to a corresponding portion of the waU

of the blood vessel - aorta 203, and U-shaped staples 21 themselves

entirely extend from recesses of corresponding cartridges 7 and are

released from these cartridges 7. [0109] Then, if necessary, cartridges 7 are reloaded with standby U-

shaped staples 21, which is accompUshed after withdrawal of swing lock

39 by partial removal of flexible pushers 57, actuated, in their turn, via

pressure bush 51, second connecting means - pressure tube 19 and

second control means - pressure handle 31 associated with the pushers.

As a result, each of the spring-loaded standby U-shaped staples 21

extends from through slot 97 of a corresponding cartridge 7, and then, at

reverse motion of a corresponding flexible pusher 57, moves under its

action into recess 83 wherein basic U-shaped staple 21 was located before

(FIG. 17, 18). Thereby endovascular apparatus 1 is made ready for

repeated suturing of prosthesis - graft or stent-graft 201.

[0110] Then, if repeated suturing is necessary, standby U-shaped staples

21 are set in motion. This is accomplished via flexible pushers 57

actuated, in their turn, via pressure bush 51, second connecting means -

pressure tube 19 and second control means - pressure handle 31, much as

basic staples 21 were extended before. As a result, pointed ends 79 of

each of the standby U-shaped staples 21 enter shaping grooves 93 of

curvilinear guiding surface 91 of a corresponding detachable cartridge 7,

are curled therein, diverging in opposite sides from one another, pierce

the waU of the prosthesis - graft or stent-graft 201 and surrounding wall

of a blood vessel, in this case aorta 203, and return again over a spiral to curvilinear guiding surface 91, repeating this rotation if permitted by the

given length of staples 21 (FIG. 19, 20). Thereby the wall of graft or

stent-graft 201 gets sutured by wire spirals formed from standby U-

shaped staples 21 to a corresponding portion of aorta 203, and standby U-

shaped staples 21 themselves entirely extend from recesses 83 of

corresponding cartridges 7 and are released from these cartridges 7.

[0111] At last, at the final step, the deUvered prosthesis - graft or stent-

graft 201 is separated from endovascular apparatus 1. This is performed

by ttirning the pivoting head 29 to remove the working fluid from balloon

75, and working head 5 returns to its initial position, and radial tongues

59 remove from graft or stent-graft 201 and are separated therefrom.

Then endovascular apparatus 1 is brought in inoperative position and

removed from the prosthesis - graft or stent-graft 201 and from aorta 203.

[0112] Application of the suggested apparatus, as well as performing, on

the basis of this apparatus, a new and improved method for securing

grafts and stent-grafts to a blood vessel waU permits to solve the problem

of preventing grafts and stent-grafts from displacement from an assigned

position within a blood vessel, which may occur due to peristelsic

oscUlations of blood vessel waUs and shaking of a patient's body during

his movement. [0114] While this invention has been described in conjunction with

specific embodiments thereof, it is evident that many alternatives,

modifications and variations will be apparent to those skUled in the art.

Accordingly, the preferred embodiments of the invention as set forth

herein are intended to be iUustrative, not limiting. Various changes may

be made without departing from the spirit and scope of the invention as

defined in the following claims.

Claims

1. Endovascular aortic apparatus for deUvery and fixation of

endovascular grafts or stent-grafts, comprising: a) a tubular body configured for positioning within a vessel, rigid in longitudinal direction and flexible in lateral direction; b) an expandable working head with cartridges for location of fastener means, disposed near the free ends of said tubular body and made expandable to retain a deUvered graft or stent-graft in contact with the inner surface of a blood vessel at the moment of their mutual fixation; c) at least four cartridges which are incorporated in the construction of this expandable working head, each of them configured for the location of at least two fastener means, these cartridges being provided with means for retaining therein fastener means, for imparting progressive motion thereto, for shaping the fastener means during their extension from these cartridges as weU as for storage and deUvery of standby fastener means; d) a control mechanism provided at least with one first control means and at least with one second control means, said control mechanism being disposed at the end of tubular body opposite to the working head and associated with this working head via said tubular body and a retaining tube enclosed therein, rigid in longitudinal direction and flexible in lateral direction, said first control means serving to control the expansion or contraction of the expandable working head, and said second control means serving to control the extension of said fastener means of each of at least four cartridges, as well as to control the reloading of each of said cartridges with at least one standby fastener means,

whereby there may be accompUshed a surgical procedure for a graft or

stent-graft delivery and its fixation to the waU of a blood vessel,

substantially the aorta, from inside the aorta.

2. An endovascular apparatus according to claim 1, wherein said

expandable working head contains a first and second bearing bushes and

a pressure bush, arranged in succession one after another in alignment

with said tubular body, as weU as an axial rod rigidly connecting with the

first supporting bushes, the second supporting bush being connected with

the body of said control mechanism via a retaining tube passing via a

through axial hole of said pressure bush, said retaining tube being located

within the tubular body and is concentric thereon.

3. An endovascular apparatus according to claim 2, wherein said

expandable working head is provided at least with four cartridges

pivotaUy secured by one there ends on said second bearing bush and

pivotaUy connected by their other ends with bearing levers which are

pivotaUy mounted on said first bearing bush.

4. An endovascular apparatus according to claim 2, wherein said

expandable working head is provided at least with six cartridges pivotaUy

secured by one there ends on said second bearing bush and pivotaUy

connected by their other ends with bearing levers which are pivotaUy

mounted on said first bearing bush.

5. An endovascular apparatus according to claim 2, wherein said

expandable working head is provided at least with eight cartridges

pivotally secured by one there ends on said second bearing bush and

pivotally connected by their other ends with bearing levers which are

pivotaUy mounted on said first bearing bush.

6. The apparatus of claim 1, wherein said expandable working head

contains a first and a second bearing bushes and a pressure bush arranged

in succession one after another beginning from the free end of this

working head and in aUgnment with this tubular body, as weU as an axial tube with a balloon disposed between the first and the second bearing

bushes, the axial tube being connected with the first bearing bush and

passing via through axial holes in the second bearing bush and in the

pressure bush.

7. The apparatus of claim 6, wherein said expandable working head

contains an axial tube with a balloon connected with the first bearing

bush and passing via through axial holes in the second bearing bush and

in the pressure bush, the baUoon disposed between the first and the

second bearing bushes serving to expand and contract the expandable

working head.

8. The apparatus of claim 6, wherein said expandable working head

contains an axial tube with two baUoons connected with the first bearing

bush and passing via through axial holes in the first and the second

bearing bushes and in the pressure bush, the first balloon disposed

between the first and the second bearing bushes, inside the expandable

working head, serving to expand and contract this expandable working

head, and the second baUoon disposed at the free end of said axial tube,

outside the expandable working head, serving to cut off the blood vessel

lumen at the moment of suturing the graft or stent-graft.

9. The apparatus of claim 6, wherein said expandable working head is

provided at least with eight cartridges pivotaUy secured by one there ends

on said second bearing bush and pivotaUy connected by their other ends

with bearing levers which are pivotaUy mounted on said first bearing

bush.

10. The apparatus of claim 2 and 6, wherin said expandable working head

is provided with means for securing a deUvered graft or stent-graft

disposed on said bearing levers near their pivotal connections with

corresponding cartridges.

11. The apparatus of claim 1, wherein each of said cartridges contains at

least one basic fastener means, substantiaUy U-shaped staple, disposed in

this cartridge substantiaUy along its longitudinal axis, with free pointed

ends facing said means for shaping, said U-shaped staple being disposed

in the cartridge to progressively extend therefrom and be shaped during

this extension, and the means for shaping in each cartridge is located near

its pivotal connection with a corresponding bearing lever.

12. The apparatus of claim 11, wherein each of said cartridges contains a

means for retaining therein at least one basic fastener means, substantiaUy

U-shaped staple, this means for retaining being disposed along the

cartridge and containing substantiaUy a sUding Ud.

13. The apparatus of claim 11, wherein each of said cartridges includes at

least one means for imparting progressive motion to said fastener means,

substantiaUy U-shaped staple, and this means contains a flexible pusher,

rigid in longitudinal direction and flexible in lateral direction.

14. The apparatus of claim 11, wherein each of said cartridges is

provided with a flexible pusher which is associated by one its end with

said pressure bush of expandable working head and disposed under said

sUding Ud to reciprocate in the clearance between the cartridge bottom

and said sUding lid.

15. The apparatus of claim 11, wherein each of said cartridges has a

bottom and a sUding Ud and contains a means for storing at least one

standby fastener means, substantiaUy a standby staple, this means for

storing containing a slot in the cartridge bottom wherein there is located

at least one spring-loaded standby U-shaped staple disposed in this slot

substantially along the cartridge longitudinal axis, with free pointed ends facing said means for shaping, said at least one standby U-shaped staple

being disposed in the slot of said cartridge bottom substantiaUy under

said flexible pusher to extend from this slot under the action of the spring

and at partial removal of the flexible pusher from the clearance between

the cartridge bottom and said sUding Ud.

16. The apparatus of claim 15, wherein said slot in the bottom of each of

said cartridges is a through one, and the standby U-shaped staple is

disposed in this slot immediately under said flexible pusher and spring-

loaded from the opposite side.

17. The apparatus of claim 1, wherein each of said cartridges contains at

least one basic and at least one one standby fastener means, substantially

U-shaped staples, and these staples are fabricated from one of the

materials of a group including stainless steel, titanium and shape memory

alloys.

18. The apparatus of claim 1, wherein said expandable working head is

provided at least with four cartridges evenly arranged about the

longitudinal axis of this head pivotaUy connected by one their ends with

its second bearing bush and pivotaUy associataed by their other ends with

bearing levers which are pivotaUy mounted on said first bearing bush, aU the cartridges together with their sUding lids, flexible pushers and bearing

levers are identical and interchangeable.

19. The apparatus of claim 8, which is additionaUy provided with a

means for axial positioning containing a part of said axial tube with a

second baUoon at the free end projecting from the expandable working

head in aUgnment with the latter, the tube and the second baUoon being

provided with a measuring scale on its outer surface.

20. The apparatus of claim 8, which is additionally provided with a means

for radial precision positioning containing markers-X-ray contrast marks

evenly appUed on the outer surface of said cartridges near the spots of

their connection with said bearing levers to orient the expandable

working head to its operation angle.

21. The apparatus of claim 6, wherein said axial tube is connected via the

first connecting means with said first control means of control

mechanism, the pressure bush is operatively connected via the second

connecting means with said second control means of control mechanism,

and the second bearing bush is connected with the body of said control

mechanism via a retaining tube passing via a through hole of the pressure

bush, said first connecting means, retaining tube and said second connecting means are disposed inside said tubular body concentrically

with one another and this tubular body.

22. The apparatus of claim 21, wherein said first connecting means for

connection of said axial tube with said first control means of control

mechanism contains a hydrauUc line.

23. The apparatus of claim 21, wherein said second connecting means for

operative connection of said pressure bush with said second control

means of control mechanism is mechanic.

24. The apparatus of claim 21, wherein said second connecting means for

operative connection of said pressure bush with said control means of

control mechanism is hydraulic.

25. The apparatus of claim 1, wherein said control mechanism at least

with one first control means and at least with one second control means

may be suppUed with detachable additional sections to locate

supplementary control means therein.

26. The apparatus of claim 15, wherein each of said cartridges has a body

with a bottom provided with a recess to locate at least one basic fastener

means, substantially U-shaped staple, and a through, slot to locate at least

one standby fastener means, substantially U-shaped spring-loaded staple,

slots for mounting said sliding Ud, as weU as a longitudinal duct to locate

at least one said flexible pusher, the basic U-shaped staple being disposed

in recess of the cartridge body bottom in frictional contact with the

sUding Ud, which prevents it from faUing out of this recess, and the

standby spring-loaded U-shaped staple is disposed in the through slot of

said cartridge body bottom in frictional contact with the flexible pusher,

which prevents it from extending from this through slot before a partial

removal of said flexible pusher.

27. The cartridge of claim 26, which has a body with a bottom provided

with a recess for at least one basic fastener means, substantially U-shaped

staple, this recess is symmetric about the longitudinal axis of this

cartridge and paraUel with its outer surface, the cartridge being provided

with a means for shaping said U-shaped staple during its extension from

said recess, and this means contains a curvilinear guiding surface

connecting said recess for a U-shaped staple with the outer surface of the

cartridge.

28. The cartridge of claim 27 which is supplied with a means for shaping

the U-shaped staple during its extension fom this cartridge, this means

containing a curvilinear guiding surface connecting the bottom of said

recess for a U-shaped staple with the outer surface of this cartridge, and

said curvUinear guiding surface has shaping grooves.

29. The cartridge of claim 28, wherein said shaping grooves diverge at an

acute angle from one another and from the longitudinal axis of this

cartridge.

30. The cartridge of claim 28, wherein at least one basic fastener means,

substantiaUy U-shaped staple, has pointed free ends and is disposed in

said recess of this cartridge body in such a way that its pointed ends face

the corresponding shaping grooves on said curvilinear guiding surface.

31. The cartridge of claim 30, wherein said shaping grooves diverge at an

acute angle from one another and from the cartridge longitudinal axis to

provide heUcal oppositely directed curling of pointed ends of a

corresponding U-shaped staple during its movement over the body recess

and shaping grooves of said curvilinear guiding surface of this cartridge.

32. The cartridge of claim 1, shaped substantiaUy as a polyhedral prism

with two skewed side faces inclined at an acute angle to one another, the

vertex of this acute angle lying on the longitudinal axis of said

expandable working head.

33. The cartridge of claim 32, shaped substantiaUy as a polyhedral prism

provided with means for connection with said expandable working head.

34. The cartridge of claim 33, shaped substantiaUy as a polyhedral prism

provided with means for connection with said expandable working head,

these means substantially containing arms with holes, and these arms

project from both bases of said polyhedral prism and are integral with this

polyhedral prism.

35. The bearing levers of said expandable working head of claim 10,

which are provided with means for securing a deUvered graft or stent-

graft shaped substantially as radial tongues located at the ends of these

bearing levers, near the pivotal connections with the cartridges.

36. A method for deUvery and fixation of a graft or stent-graft to the waU

of a blood vessel from inside the latter comprising the foUowing

successive steps: i) preparing a graft or stent-graft for deUvery, its mounting and securing on the surface of said expandable working head of the apparatus for deUvery and fixation of a graft or stent- graft, as weU as crimping a graft or stent-graft to an assigned outer diameter;

ii) setting the apparatus for deUvery and fixation in operaive position, its insertion into a corresponding blood vessel, bringing said expandable working head to the securing area, precision axial and radial positioning of said apparatus at a given point of the blood vessel via a measuring scale on the surface of said axial tube and balloon and via markers-X-ray contrast marks, as well as deploying the working head in such a way that the delivered graft or stent-graft comes in contact with the inner surface of said blood vessel at the moment of their mutual fixation, and the cartridges of his expandable working head are located near corresponding suttiring points;

iii) setting in motion said U-shaped staples, accompUshed via said flexible pushers which are, in their turn, activated via the pressure tube, second connecting means and second control means which are associated with these flexible pushers, whereby pointed ends of each of the U-shaped staples enter the shaping grooves of said curvilinear guiding surface of a corresponding detachable cartridge, are curled therein diverging in opposite directions from one another, pierce the graft or stent-graft wall and the surrounding blood vessel wall and return again over a spiral to said curvUinear guiding surface, repeating this rotation if permitted by the given length of staples, whereby the graft or stent-graft wall gets sutured by wire spirals formed from U-shaped staples to a corresponding portion of said blood vessel wall, and said U- shaped staples entirely emerge from the recesses of corresponding cartridges and are released from these cartridges;

iv) reloading the cartridges with standby U-shaped staples accompUshed by partial removal of said flexible pushers activated, in their turn, via the pressure bush, second connecting means and second control means associated with these flexible pushers, whereby each of the spring-loaded standby U-shaped staples extends from the through slot of a corresponding cartridge, and then, at reverse motion of a corresponding flexible pusher, moves due to its action to said recess where the basic U-shaped staple was located before, so that the appartus for deUvery and fixation gets ready for

repeated suttiring;

in case repeated suturing is necessary,, setting in motion said

standby U-shaped staples accomplished by said flexible

pushers activated, in their turn, via the pressure bush, second

connecting means and second control means which are

associated with these flexible pushers, so that pointed ends

of each of the standby U-shaped staples enter said shaping

grooves of the curvilinear guiding surface of a corresponding

detachable cartridge, are curled therein, diverging in opposite

directions from one another, pierce the graft or stent-graft

waU and the surrounding blood vessel waU and return again

over a spiral to said curvilinear guiding surface repeating this

rotation if permitted by the given length of staples, whereby

the graft or stent-graft wall gets repeatedly sutured by wire

spirals formed from U-shaped staples to a corresponding

portion of said blood vessel waU, and said standby U-shaped

staples entirely emege from recesses of corresponding

cartridges and are released from these cartridges;

detaching the delivered and sutured graft or stent-graft from

the apparatus for delivery and fixation, and vii) bringing the apparatus for deUvery and fixation in inoperative position and its removal from the graft or stent-graft and from the blood vessel