WO2005079151A2 - Endovascular apparatus system and method for delivery and fixation of intravascular devices - Google Patents

Abstract

The present invention relates to medical techniques. More particularly, the present invention relates to methods and apparatus for securing endovascular devices, such as grrrafts or stent-grafts, to the walls of blood vessels in direction from inside these vessels to their outer surface. There is suggested an endovascular apparatus used for delivery and fixation of grafts or stent-grats to the walls of blood vessels, substantially the aorta. The apparatus comprises: a tubular body, at least one detachable cartridge with at least with one (astener means, a holder at least for one detachable cartridge, a control mechanism, as well as a first, second and third connecting means. There is also suggested a method for delivery and fixation of a graff or stent-graf to the wall of a blood vessel from within the latter.

Description

ENDOVASCULAR APPARATUS SYSTEM AND METHOD FOR DELIVERY AND FIXATION OF INTRAVASCULAR DEVICES

(3D) Priority Data:

ΪL 130457 19 Fufaraary 2604 (19.02.2604) IL 16045B 19 February 2004 (19.02.2004) IL 160459 19 February 2004 (19.02.2004)

BACKGROUND OF THE INVENTION

[ββøll 1. Fϊeϊd of the Invention

β02] 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. [0003] 2. Description of Related Art

Ϊ0004] Occlusion of great blood vessels results from the formation of

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

thrombogenesis 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.

{0605} 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 the

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.

AH 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 shajped as a spring or has

elastic members bearing up against the blood vessel wall or hooking

thereon.

{0006} 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.

{0007} 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 rapture - 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 it divides into iliac arteries. The iliac

arteries, in turn, supply blood to the perineal 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 m

diameter in this 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 than five centimetres because no statistical benefit

exists in performing such procedures.

{øølø} 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. Although the mortality rate for a ruptured

aortic aneurysm is extremely high, 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, there 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 intra-abdominal surgery. It is, therefore, desirable to

reduce the mortality and morbidity associated with mfra-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 without the attendant risks of

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

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

for Graft Device for Treating Abdominal Aortic Aneurysm and its patent

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

5683452, 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 rninimal 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

010487A1, 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 "Endovascular Expander of

a Non-migrant Positioning", EP 948945 A2 "Endovascular Prosthesis

with Fixation Means".

{0015} Migration of grafts and/or stent-grafts from detemiined 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 there 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 like*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 "Fixator for arteries", WO

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

repair of arteries⁷'. 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 ^KY" 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 operaions 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 through 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 this 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 this 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",

see Hogendijk, Michael et al., U.S. Pat. 5713907.

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

expanding catheter" by Bar-Cohen, Yaniv, 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 mtraluminal stents. A permeablej

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 iliac arteries.

Additional steps can be taken to ensure that 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 flow

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, Wilhelmus et al, in U.S. Pat. 6485496 and U.S.

Pat.AppI. 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

circumferentially provided means, such as pin-shaped elements, for joining the abutting walls of the hollow stractures 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} Parodi, 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, Parodi, 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 &aά 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 applier 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 applier 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 movably 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 wails 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 perfoπning 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} A 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 elements and

comprises a tubular body, at least one detachable cartridge at least with

one fastener means, substantially U-shaped staple, and a control

mechanism. This at least one detachable cartridge is secured on the

tubular body or on a holder connected with a control mechanism via a ^•

tubular body including a first, second and third connecting means.

[0034} The tubular body is configured for positioning within a blood

vessel. It is rigid in longitudinal direction and flexible in lateral direction.

{0035} The apparatus includes at least one detachable cartridge adapted

for receiving at least one fastener means. This detachable cartridge is

disposed near the free end of the tubular body and provided with a means

for retaining therein the fastener means, for imparting thereto progressive

movement and for forming this fastener means during its extension from

this cartridge. {0036} At least one fastener means, sabstantially a U-shaped staple, is

disposed in at least one detachable cartridge, substantially lengthwise of

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

The U-shaped staple is disposed in the detachable cartridge to

progressively extend therefrom and be formed during this extension.

[0037} The control mechanism provided with a first, second and third

control means Is disposed on the tubular body end opposite to the at least

one detachable cartridge. The control mechanism is associated with the

at least one detachable cartridge via this tubular body and a bearing

member located within this body and being rigid in longitudinal direction

and flexible in lateral direction. The first control means serves to control

the securing of a delivered graft or stent-graft on the apparatus, the

second control means serves to control the detachment of the delivered

graft or stent-graft from the apparatus, and the third control means serves

to control the extension at least of one fastener means from at least one

detachable cartridge.

{0038} Near the free end of this tubular body there may be also disposed

a holder at least for one detachable cartridge. This holder is provided with

members for securing this at least one detachable cartridge and means for

securing a delivered graft or stent-graft. The holder for at least one detachable cartridge comprises a first and second supporting bushes and a

pressure bush arranged in succession after each another coaxially with the

tubular body, as well as an axial rod rigidly connecting the first and

second supporting bushes. The second axial bush is connected with the

body of control mechanism via a bearing member shaped as a link

passing via a through axial hole in the pressure bush, and this link is

located within this tubular body concentrically thereon.

[0039} The holder is provided with up to four detachable cartridges

evenly arranged around the holder and secured by Its ends on the first and

second supporting bushes. Besides, the holder is provided with members

for securing this up to four detachable cartridges. It may be as well

provided with means for securing a delivered graft or stent graft disposed

substantially on the first supporting bush.

[0040} Each detachable cartridge comprises a means for retaining therein

at least one fastener means, substantially a U-shaped staple. This means

for retaining is disposed lengthwise of the cartridge and is shaped

substantially as a sliding lid. [0041} Besides, each detachable cartridge includes at least one means for

Imparting progressive movement to the fastener means, substantially U-

shaped staple. This means contains a flexible pusher, flexible in lateral

direction and rigid in longitudinal direction. All the detachable cartridges

with their sliding lids and flexible pushers are identical and

interchangeable.

[0042} The tubular body of this endovascular apparatus includes a first

connecting means for operative connection of the first control means with

means for securing a delivered graft or stent-graft on the apparatus, a

second connecting means for operative connection of the second control

means with means for detaching a delivered graft or stent-graft from the

apparatus, as well as a third connecting means for operative connection of

the third control means with means for imparting progressive movement

at least to one fastener means.

[0043} The control mechanism of this endovascular apparatus has at least

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

third control means. The control mechanism may be provided with

detachable additional sections for locating therein additional control

means. [0044} The described endovacular apparatus has a first connecting means

for operative connection of the first control means with means for

securing a delivered graft or stent-graft on the apparatus which may be

mechanical or hydraulic.

[0045} There Is also a second connecting means for operative connection

of the second control means with means for detaching a delivered graft or

stent-graft from the apparatus which may be mechanical or hydraulic.

[0O46J And at last, there is a third connecting means for operative

connection of the third control means with means for imparting

progressive movement at least to one fastener means, which may be

mechanical or eleetical.

[0047} The detachable cartridge of the endovascular apparatus has a

body with a recess for receiving at least one fastener means, substantially

a U-shaped staple, slots for mounting the sliding lid, as well as a

longitudinal duct for receiving at least one flexible pusher. The U-shaped

staple is located in the recess in frϊctlonal contact with this sliding lid,

which prevents It from falling out of this recess. Besides, this recess is

symmetric about the longitudinal axis of this cartridge and parallel with

its outer surface. {0048} Each detachable cartridge is provided with 'a means for foπriing

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

shaped as a curvilinear guiding surface connecting the bottom of this

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

curvilinear guiding surface has forming grooves which diverge at an

acute angle from each other and from the longitudinal axis of this

detachable cartridge.

[0049J In the suggested detachable cartridge at least one fastener means,

substantially a U-shaped staple, has pointed free ends and is located in a

recess of the body of this detachable cartridge in such a way, that its

pointed ends face the corresponding forming grooves on the curvilinear

guiding surface.

[0050} The forming grooves In this detachable cartridge diverging at an

acute angle from each other and from the cartridge longitudinal axis

provide helical oppositely directed curling of pointed ends of a

corresponding U-shaped staple during its movement over the body recess

and forming grooves of the curvilinear guiding surface of this detachable

cartridge. [0051} The detachable cartridge Is shaped substantially as a polyhedral

prism with two skewed lateral faces inclined at an acute angle to one

another, the vertex of this acute angle being located on the longitudinal

axis of a holder for at least one detachable cartridge.

{0052} The detachable cartridge is provided with means for connection

with the holder, and these means contain substantially arms with holes,

these arms projecting from both bases of the polyhedral prism and being

integral with this polyhedral prism.

{0053} The at least one detachable cartridge or the first supporting bush

of the holder for at least one detachable cartridge may be additionally

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

containing substantially movable radial tongues which are evenly

arranged at the free end of this cartridge or this bush to extend from this

cartridge or this bush on operating the first control means of the control

mechanism. These movable radial tongues may also serve as a means for

detaching a delivered graft or stent-graft and are capable of sinking into

the cartridge body or into the bush body on operating the second control

means of this control mechanism. {0O54} 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 within the latter.

{0055} This method comprises the following successive steps: i)

assembly of the device for delivery and fixation of a graft or stent-graft

from the suggested kit of standardized elements, ii) preparing a graft or

stent-graft for delivery and its securing on a cartridge or a holder of the

endovascular apparatus, iii) bringing the endovascular apparatus into

operative position, iv) setting in motion the U-shaped staples and

securing the graft or stent-graft, v) detaching the delivered and sutured

graft or stent graft from the endovsacular apparatus, and vi) removing the

endovasular apparatus from the blood vessel.

{0056} At the first step the device for delivery and fixation of a graft or

stent-graft adapted for anthropometric conditions of a specific patient

and intended for performing a surgical operation to deliver a graft or

stent-graft and fix it to the walls of a blood vessel, substantially the aorta,

is assembled of standardized elements. [0057} At the next step the graft or stent-graft is prepared for delivery,

mounted and secured on the surface of this endovascular apparatus deta¬

chable cartridge or holder, as well as crimped to an assigned diameter.

[0058} Then the endovascular apparatus for delivery is brought into

operative position, inserted into a corresponding blood vessel and brought

to the securing point in such a way, that its detachable cartridges are

located near corresponding suturing points. Thereupon U-shaped staples

are set in motion. This is achieved via means for imparting progressive

movement to the staples, and these means are, in their turn, actuated via

the third control means and third connecting means associated with these

means for imparting progressive movement. As a result, pointed ends of

each U-shaped staple enter the forming grooves on the curvilinear

guiding surface of a corresponding detachable cartridge, curl 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 the curvilinear guiding surface of a corresponding

detachable cartridge, repeating this rotation. As a result, the graft or stent-

graft wall gets sutured, via wire spirals formed from U-shaped staples, to

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

themselves entirely emerge from recesses in detachable cartridges and

separate from these cartridges. [0059} Then the delivered and sutured graft or stent-graft is detached

from the endovascular apparatus, the endovascular apparatus for delivery

is brought into inoperative position and removed from the graft or stent-

graft and from the blood vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

[0060} The invention will now be described in conjunction with the

following drawings in which like reference numerals designate like

elements and wherein:

[0061} FIG. 1 shows general views of the suggested apparatus;

[0062} FIG. 2 shows a general view of the kit of elements for assembling

an apparatus of the suggested system;

[0063} FIG. 3 shows the general view of one of the apparatus of the

suggested system;

[0064} FIG. 4 shows the head of the first embodiment of the apparatus of

the suggested system in open position; [0065} FIG. 5 shows a diagram of a graft or stent-graft fixation within the

aorta neck:

[0066] FIG. 6 shows a general view of the suggested removable

cartridge as an assembly;

[O067} FIG. 7 - 10 show successive stages of shaping a staple while it is

emerging from the cartridge;

[0068} FIG. 11 shows a general view of the second embodiment of the

suggested apparatus;

[0069} FIG. 12 shows a general view of the working part of the second

embodiment of the suggested apparatus, including the cartridge;

[0070} FIG. 13 shows the cartridge of the second embodiment of the

suggested apparatus, in assembly with the lid and flexible pusher;

[0071} FIG. 14 show general views of the control mechanism according

to the second embodiment of the suggested apparatus; [0072} FIG. 15 - 16 show two cartridge embodiments with movable

radial tongues of the second embodiment of the suggested apparatus.

[0073} FIG. 17 - 18 show general views of the third embodiment of the

suggested apparatus;

[0074} FIG. 19 - 20 show general views of the working part of the third

embodiment of the suggested apparatus, without means for securing a

graft or stent-graft;

[0075} FIG. 21 - 22 show general views of the working part of the third

embodiment of the suggested apparatus, with means for securing a graft

or stent-graft;

[0076] FIG. 23 shows the general view of a detachable cartridge;

{0077} FIG. 24 shows the general view of a detachable cartridge

according the third embodiment of the suggested apparatus in assembly

with a sliding lid;

[O078} FIG. 25 shows the general view of a control mechanism of the

third embodiment of the suggested apparatus; [0079] FIG. 26 shows the longitudinal section of a control mechanism of

the third embodiment of the suggested apparatus;

[0080} FIG. 27 shows a diagram of performing the suggested method.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0081} 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.

[0082] The most preferred embodiments of an apparatus system,

according to the present invention, are shown in drawing figures 1 - 27. [0O83J The suggested system of endovascular apparatus Is used for

delivery and fixation of intravascular devices, substantially grafts or

stent-grafts, to the walls of blood vessels, substantially the aorta. The

typical apparatus 1 of this system (FIG.l) comprises: a tubular body 3, at

least one detachable cartridge 5 with at least one fastener means,

substantially U-shaped staple and holder 7 for this at least one detachable

cartridge 5, and a control mechanism 9. The tubular body 3 includs a first,

second and third connecting means, 11, 13 and 15 respectively.

[0084} AH apparatus of this system are assembled from a kit of elements.

21 shown in FIG. 2. The kit comprises: a set of removable cartridges 23,

sets 25, 27 of fastener means, substantially U-shaped staples, tubular

bodies 29, 31 - holders for removable cartridges 23, in common sets with

means for changing spatial position of removable cartridges relative to

these tubular bodies, as well as the first, second and third connecting

means respectively (not shown in this drawing). The kit further comprises

control mechanisms 33, 35 with removable additional sections 37, 39 for

receiving therein additional control means, as well as a tool set 41, 43, 45

for apparatus assembly.

[O085} The suggested kit of elements 21 allows to assemble at lest one

device for delivery and fixation of grafts or stent-grafts shown in FIG. 3, 4. Device 51 for delivery and fixation of grafts or stent-grafts 53 contains:

at least one removable cartridge 55 having at least one fastener means -

U-shaped staple 57, holder 59 for the removable cartridge 55, as well as

means 61 for changing spatial position of at least one removable cartridge

55 relative to this holder 59 , such as a multiple-link mechanism (FIG. 4).

Besides, device 51 contains control mechanism 63, as well as a first

connecting means 65, second connecting means 67 and third connecting

means 69. It also contains demountable members for securing the

removable cartridge 55 (not shown in the drawings). Part of these

elements are shown in more detail in FIG. 3, 4, 5.

[0086] Removable cartridge 55 (FIG. 6) is intended to receive therein at

least one fastener means - U-shaped staple 57 disposed in this cartridge

substantially along its longitudinal axis. U-shaped staple 57 Is located in

the removable cartridge so as to progressively extend therefrom and be

shaped while extending. For this purpose cartridge 55 Is provided with

means for retaining therein this fastener means - U-shaped staple 57, for

imparting progressive motion thereto and for shaping the fastener means -

U- shaped staple 57 while it is extending from this cartridge 55. U-shaped

staple 57 has free pointed ends 71 facing the means 73 for shaping this

staple 57. U-shaped staple 57 is located in removable cartridge 55 to

progressively extend therefrom and be shaped while extending. [0087} The means for retaining in removable cartridge 55 at least one

fastener means - U-shaped staple 57 is located lengthwise of removable

cartridge 55 and Is formed as a sliding lid 75 (FIG. 6).

[0O88] The means for imparting progressive motion to fastener means -

U-shaped staple 57 (FIG. 6) Is a flexible pusher 77 which Is flexible in

lateral direction and rigid In longitudinal direction.

{0089} Each apparatus of the system further Includes control mechanism

63 (FIG. 3) provided with at least one first control means 79, at least one

second control means 81, and at least one third control means 83. This

control mechanism 63 is associated with holder 59 for at least one

removable cartridge 55 via bearing member 85 which is flexible in lateral

direction and rigid in longitudinal direction (FIG. 3). First confrol means

79 serves to control the deployment of delivered graft or stent-graft 53

(FIG. 3), second control means 81 serves to confrol aforesaid means 61

for changing the spatial position of at least one removable cartridge 55

relative to holder 59, and third control means 83 serves to control the

extension of fastener means - U-shaped staple 57 from a corresponding

removable cartridge 55. [0090] First connecting means 65 (FIG. 3) serves to operatively connect

first control means 79 with the means for controlling the deployment of a

delivered graft or stent-graft, such as a hydraulic balloon (not shown in

the drawings). Second connecting means 67 (FIG. 3) is intended for

operative connection of second control means 81 with means 61 for

changing the spatial position of at least one removable cartridge 55

relative to holder 59. And finally, third connecting means 69 serves for

operative connection of third control means 83 with means 77 for

imparting progressive motion to the fastener means - U-shaped staple 57

(FIG. 3 - 6).

[0091] First connecting means 65 for operative connection of first

control means 79 with the means for controlling the deployment of a

delivered graft or stent-graft 53 may be hydraulic, such as a hydraulic

line, or mechanical, such as a pressure member, in particular, a pressure

tube or tie-rod.

[0092] Second connecting means 67 for operative connection of second

control means 81 with means 61 for changing the spatial position of at

least one cartridge 55 relative to holder 59 may be hydraulic, such as a

hydraulic line, or mechanical, such as a pressure tube 67 (FIG. 4). [Θ093} Third connecting means 69 for operative" connection of third

confrol means 83 with means for imparting progressive motion to fastener

means - U-shaped staple 57 may be mechanical or electrical, such as a

pressure tie-rod or wire (FIG. 3, 4).

[0094} Control mechanism 63 with at least one first control means 79, at

least one second control means 81, and at least one third control means 83

may be provided with removable additional sections 37, 39 for receiving

additional confrol means (FIG. 2, 3).

[O095J Removable cartridge 55 Is shown in more detail in FIG. 6-10. It

has a body 89 provided with a recess 91 for receiving at least one fastener

means - U-shaped staple 57, slots 93 for mounting a sliding lid 75, as well

as a longitudinal duct 95 to receive at least one flexible pusher 77. U-

shaped staple 57 is located in its recess 91 in frictlonaϊ contact with

sliding lid 75, which prevents it from falling out of this recess 91 (FIG.

6). Recess 91 In removable cartridge 55 is symmetrical about its

longitudinal axis and parallel to Its outer surface (FIG. 6). [0096] The cartridge is provided with a means for shaping U-shaped

staple 57 while it is being extended from recess 91 of cartridge 55 (FIG. 6

- 10). This means is shaped as a curved guiding surface 73 which

connects the bottom of recess 91 for U-shaped staple 57 with the

cartridge outer surface. Curved guiding surface 73 is provided with

shaping grooves 97 diverging at an acute angle from one another and

from the longitudinal axis of removable cartridge 55 (FIG. 6).

[0097] U-shaped staple 57 has pointed free ends 71 (FIG. 6) and is

disposed in a corresponding recess of the body in such a way that its

pointed ends 71 face the corresponding shaping grooves 97 on curved

guiding surface 73. Shaping grooves 97 diverge at an acute angle from

one another and from the longitudinal axis of curved guiding surface 73

to provide helical oppositely directed curling of pointed ends of a

corresponding U-shaped staple during its movement over recess 91 of

body 89 and shaping grooves 97 of removable cartridge 55. This is shown

in more detail in FIG. 7 - 10.

[0098] In this apparatus at least one removable cartridge 55 may serve as

a means for securing a delivered graft or stent-graft (FIG. 3, 4). For this

purpose it may be provided with hooks or needles for hooking a

corresponding end of a graft or stent-graft (not shown in the drawings). Removable cartridge 55 may also be used as a means for deployment of a

delivered graft or stent-graft 53 (FIG. 5).

{øø99} The second embodiment of the suggested endovascular apparatus

is shown In FIGS. 11- 16 and may be used for delivery and fixation of

grafts or stent-grafts to the walls of small diameter blood vessels. This

apparatus 101 (FIG. 11) comprises: cartridge 103, wherein there are

located at least one fastener means, substantially U-shaped staple 105,

tubular holder 107 for cartridge 103, control mechanism 109, as well as

first connecting means 111, second connecting means 113 and third

connecting means 115, these means linking control mechanism 109 with

cartridge 103 and arranged concentrically within each other.

[øløø} FIG. 12 shows a general view of the apparatus working part,

Including cartridge 103. Cartridge 103 Is intended for receiving U-shaped

staple 105, On cartridge 103 there is secured a tubular holder I07 with

elements for securing the cartridge. The cartridge 3 and holder 7 may be

formed as a single unit (FIG. 12).

[øløl] Cartridge 103 (FIG. 12, 13) comprises a means for retaining

therein U- shaped staple 105 which is disposed lengthwise of cartridge

103 and formed as a sliding lid 117 with hole 119 for gripping lid 117 by a tool (FIG. 3). Cartridge 103 further includes at least one means

for imparting progressive motion to U- shaped staple 105, and this means

is formed as a flexible pusher 121 which is flexible in lateral direction

and rigid in longitudinal direction (FIG. 12). And at last, cartridge 103 is

provided with a means for fo ilng U-shaped staple 105 during Its

extension from cartridge 103, this means comprising a curvilinear

guiding surface 123 (FIG. 13).

[0102] U-shaped staple 105 is located in carfridge 103 in recess 125 and

aligned with longitudinal axis 127 (FIG. 13) of cartridge 103. Recess 125

is symmetrical about longitudinal axis 127 of cartridge 103 and parallel

with the outer surface of this cartridge 103. U-shaped staple I05 has free

pointed ends 129 facing the means for fomilng which is shaped as a

curvilinear guiding surface 123 connecting the bottom of recess 125 for

U-shaped staple 105 in the body of cartridge 103 with the outer surface of

cartridge 103. U-shaped staple I05 Is located in recess 125 of carfridge

103 to perform progressive motion therefrom and be formed during this

extension (FIG. 13). [0103} The cartridge body further contains slots 131 for mounting sliding

lid 117, as well as longitudinal duct 133 to locate flexible pusher

121 (FIG. 13). U- shaped staple 105 is disposed in Its recess 125 in

frlctional contact with sliding lid 117 to prevent its falling out of this

recess 125.

[0104] Curvilinear guiding surface 123 has forming grooves 135, 137

thereon diverging at an acute angle from one another and to longitudinal

axis 127 of cartridge 103 (FIG. 13).

[0105] U-shaped staple 105 having pointed free ends 129 is disposed in

recess 125 in such a way that its pointed free ends 129 are facing the

corresponding forming grooves 135, 137 on curvilinear guiding surface

123 of cartridge 103 (FIG. 13). Forming grooves 135, 137 diverge at an

acute angle from one another and from longitudinal axis 127 of cartridge

103 to provide helical, oppositely directed curling of pointed ends 129 of

a corresponding U- shaped staple 105 during its movement over recess

125 and forming grooves 135, 137 of cartridge 103 (FIG. 13).

[0106] Cartridge 103 is further provided with a means for securing the

delivered graft or stent-graft. This means contains substantially movable

radial tongues 139 evenly arranged at the free end of carfridge 103 to extend from the cartridge in response to the action of the first control

means of the control mechanism 109 (FIG.l l, 15). The detachment of a

delivered graft or stent-graft is performed by sinking movable radial

tongues 139 into the body of this cartridge 103 due to acting on the

second control means of control mechanism 109.

[0107] The apparatus has a control mechanism 109 with body 141 and

handle 1 3 provided at least with one first control means 145, at least one

second control means 47, and at least one third control means 149 (FIG.

11 - 16). Control mechanim 109 is associated with tubular holder 107 for ^•

the carfridge 3 via tubular bearing member 151 which is flexible in lateral

direction and rigid in longitudinal direction. In mechanism 109 first

control means 145 serves to control the securing of a delivered graft or

stent-graft on the apparatus via an extension of movable radial tongues

139 (FIG. 11 - 16). Second control means 147 serves to control the

detachment of a delivered graft or stent-graft from the apparatus by

sinking movable radial tongues 139 into the body of cartridge 103. And at

last, third control means 149 serves to control the extension of fastener

means - U-shaped staple 105 from cartridge 103. The control mechanism

may be also provided with an additional control means 153 to control, if

necessary, the reverse movement of pusher 121 (FIG. 11 - 16). [0108} Besides, suggested apparatus 101 includes a first, second and

third connecting means III, 113 and 115 respectively (FIG. 11, 14). First

connecting means 111 serves for operative connection of first confrol

means 145 with the means for controlling the securing of a delivered graft

or stent-graft on the apparatus cartridge, that is with movable radial

tongues 139. Second connecting means 113 is intended for operative

connection of second control means 147 with the means for controlling

the detachment of a delivered graft or stent-graft from the endovascular

apparatus, that Is with the same movable radial tongues 139. And at last,

third connecting means 115 serves for operative connection of third

control means 149 with the means for imparting progressive motion to

the fastener means - U- shaped staple 105.

[01O9] First connecting means 111 may be mechanical or hydraulic. This

may be, for instance, a mechanical system with spring-loaded arms 155,

at the ends whereof there are secured movable radial tongues 139. This

mechanical system is secured in the cavity of cartridge 103 (FIG. 15) and

forces movable radial tongues 139 extend through holes 157 in the body

of cartridge 103 or sink into this body. In another embodiment the system

may contain a hydraulic balloon 159 located in the cavity of cartridge 103

and connected via hydraulic line 161 with control mechanism 109 (FIG.

16). In both embodiments first and second control means 145 and 147 control the extension and sinking of movable radial tongues 139 (FIG. 11,

15, 16).

[0110] In one of the embodiments first 111 and second 113 connecting

means contain a mechanical member, such as a tube having longtudinal

rigidity and lateral flexibility. In the other embodiment it may be a

hydraulic line 161 for delivering fluid to balloon 159 and for removing

fluid from this balloon 159 (FIG. 14 - 16).

[ølll] The connecting means 115 serves to control, via third control

means 149, the extension of U-shaped staple 105 from carfridge 103. It is

mechanical, such as a pressure link 115 (FIG. 14), rigid in longitudinal

direction and flexible in lateral direction. In another embodiment

connecting means 115 Is electrical, such as a metal member with shape

memory effect, capable of changing its length when electric current is

applied thereto.

[0112] Control mechanism 109 may be supplied with detachable

additional sections for receiving therein additional control means (not

shown in the drawings). [0113] The third suggested embodiment of an endovascular apparatus is

used for delivery and fixation of graft or stent-grafts to mean diameter

blood vessels. This apparatus 201 comprises (FIG. 17 - 18) : at least one

detachable carfridge 203, with at least one fastener means, substantially

U-shaped staple 205, holder 207 for at least one detachable cartridge,

control mechanism 209, as well as a tubular body including a first, second

and third connecting means, 211, 213 and 215 respectively.

[0114} Endovascular apparatus 201 has a control mechanism 209 with at

least one control means 217, at least one second control means 219 and at

least one third control means 221 (FIG. 17, 18). If necessary, control

mechanism 209 may be provided with detachable additional sections for

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

[0115} FIG. 19 - 22 show two embodiments of the working part of the

suggested endovascular apparatus. FIG. 19 - 20 show an embodiment of

the working part of the suggested apparatus which does not comprise

means for securmg a graft or stent-graft, whereas FIG. 21 - 22 show an

embodiment of the working part of the suggested apparatus provided with

means for securing a graft or stent-graft. Otherwise, both embodiments of

the suggested apparatus are fully identical. [0116] The working part of suggested endovascular apparatus 201 is

provided with four detachable cartridges 203 evenly arranged around

holder 207 (FIG. 19 - 22). Each detachable cartridge 203 is provided at

least with one fastener means, substantially U-shaped staple 205, as well

as with a sliding lid 223 and flexible pusher 225. Sliding lids 223 serve as

a means for retaining U-shaped staples 205 in detachable cartridges 203.

Flexible pushers 225, flexible in lateral direction and rigid in longitudinal

direction, serve as means for imparting progressive motion to U-shaped

staples 205.

[0117] All detachable cartridges 203 together with their sliding lids 223

and flexible pushers 225, are identical and interchangeable, standardized

for this type of an endovascular apparatus.

[0118] Each detachable cartridge 203 of endovascular apparatus 201

(FIG. 23, 24) has a body 227 provided with a recess 229 for receiving at

least one fastener means, substantially U-shaped staple 2Θ5, slots 231 for

mounting sliding lid 223, as well as with longitudinal duct 233 for

receiving at least one flexible pusher 225. U-shaped staple 205 is located

in recess 229 in frictional contact with sliding lid 223, which prevents it

from falling out of this recess 229. Besides, recess 229 is symmetric about the longitudinal axis of cartridge 203 and parallel with its outer

surface 235.

[0119] Each detachable cartridge 203 is provided with a means for

forming U-shaped staple 205 during its extension from recess 229 (FIG.

23, 24). This means contains a curvilinear guiding surface 237 connecting

the bottom of recess 229 for U-shaped staple 205 with the outer surface

235 of detachable cartridge 203. The curvilinear guiding surface 237 has

forming grooves 239, 241, which diverge at an acute angle from one

another and from the longitudinal axis of detachable cartridge 203. U-

shape staple 205 has pointed free ends 243 and is located in recess 229 of

body 227 of this detachable cartridge 203 in such a way, that its pointed

ends 243 face the corresponding forming grooves 239, 241 on the

curvilinear guiding surface 237 (FIG. 23).

[0120] In detachable cartridge 203 forming grooves 239, 241 diverge at

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

cartridge 203 to provide helical oppositely directed curling of pointed

ends 243 of a corresponding U-shaped staple 205 during its extension

over recess 229 of body 227 and forming grooves 239, 241 of curvilinear

guiding surface 237 of detachable cartridge 203 (FIG. 23, 24). [0121} Detachable cartridge 203 is shaped substantially as a polyhedral,

in this case, a tetrahedral prism 245 (FIG. 12), with two skewed lateral

faces 247, 249 inclined at an acute angle to one another. The vertex of

this acute angle is located on the longitudinal axis of holder 207 for

detachable cartridges 203. To provide tighter arrangement of detachable

cartridges 203 on holder 207, two ribs of tetrahedral prism 245 adjacent

to outer surface 235 (in this case- to the outer face of prism 245), are

rounded (FIG. 24).

[0122] Detachable cartridge 203 Is provided with means for connection

with holder 207, and these means contain substantially arms 251, 253

with holes, 255 and 257 respectively, which project from both bases of

tetrahedral prism 245 and are integral therewith.

[0123] Holder 207 in both embodiments (FIG. 19 - 22) contains a first

supporting bush 259 and second supporting bush 261 rigidly joined

together via axial rod 263. First supporting bush 259 is rigidly mounted at

the free end of axial rod 263.

[0124] Detachable cartridges 203 are rigidly attached to supporting

bushes 259 and 261 of holder 207, in particular, via rings passing through

holes 255 and 257 in arms 251 and 253 of these cartridges 203 and fixed in annular grooves on the ends of supporting bushes 259 and 261 (not

shown in the drawings). Thereby cartridges 203, supporting bushes 259

and 261 and axial rod 263 form a rigid system. Bush 261 and rod 263

have a bearing member - link 265 rigidly attached thereto by one its end,

this link is flexible In lateral direction and rigid in longitudinal direction

and is rigidly attached by its second end to the body of control

mechanism 209. On bearing member 265 there is mounted a pressure

bush 267 capable of reciprocaton along this bearing member and rigidly

attached to the free ends of all flexible pushers 225 located in longitudinal

ducts 233 of ail detachable cartridges 203 (FIG. 19 - 22).

[0125] FIG. 21 - 22 show an embodiment of endovascular apparatus 201

wherein holder 207 for detachable cartridges 203 is additionally provided

with a means for securing a delivered graft or stent-graft, this means

substantially contains movable radial tongues 269 evenly arranged in first

supporting bush 259 of this holder 207 to extend from slots 271 of first

supporting bush 259 on operating first control means 217 of control

mechanism 209. Movable radial tongues 269 may also serve as a means

for detaching a delivered graft or stent-graft from endovascular apparatus

201, as they are capable of sinking into slots 271 of the body of first

supporting bush 259 on operating second control means 219 of said

control mechanism 209. To perform the extension or sinking relative to the body of first supporting bush 259, movable radial tongues 269 are

secured on the ends of arms 273 pivotally mounted in longitudinal slots

271 of first supporting bush 259 of holder 207. First supporting bush 259

has an axial cavity 275 enclosing a means for controlling levers 273, such

as a hydraulic balloon 277 associated via a hydraulic line (not shown in

the drawings) with control mechanism 209 (FIG. 21 - 22).

[0126] Control mechanism 209 is shown in more detail in FIG. 25, 26. It

is provided with first control means 217, second control means 219, and

third control means 221. First control means - arm 217 serves to actuate,

the delivery of working fluid to hydraulic balloon 277, second control

means - handle 219 serves to actuate the suction of working fluid from

hydraulic balloon 277, and third control means - arm 221 pivotally

attached to slider 279 (FIG. 26) serves to control the extension of U-

shaped staples 205 from cartridges 203. For convenience of control, first

and second confrol means 217 and 219 may be located in detachable

control sections connected with control mechanism 209 or disposed

independent therefrom (not shown in the drawings).

[0127] The suggested endovascular apparatus 201 has a first connecting

means 211 for operative connection of first control means 217 with

means for securing a delivered graft or stent-graft on the apparatus - movable radial tongues 269. This means 211 may be mechanical, such as

a wire link. It may also contain a hydraulic line (not shown in the

drawings), as it is the case in the second embodiment of the suggested

apparatus.

{0128} Second connecting means 213 for operative connection of second

control means 219 with means for securing a delivered graft or stent-graft

- movable radial tongues 269 is constructed likewise. This second

connecting means 213 may be also mechanical, such as a wire link. It

may also contain a hydraulic line (not shown in the drawings), as is the

case in the second embodiment of the suggested apparatus. In the second

embodiment the hydraulic line connecting hydraulic balloon 277 with a

fluid receptacle (not shown in the drawings) may be the same, whereas

the first and second confrol means 217 and 219 - separate, independant

of one another.

{0129} Endovascular apparatus 201 has also a third connecting means

215 for operative connection of third control means 221 with means for

imparting progressive motion to U-shaped staples 205, that is, with

flexible pushers 225. Third connecting means 215 may be mechanical,

such as a thin wall pressure tube 281, rigid in longitudinal direction and

flexible in lateral direction. Third connecting means 215 may be also electrical, such as a rod or tube made from a material with memory effect

(FIG. 17, 18, 26).

{0130} First, second and third connecting means, 211, 213 and 215

respectively, are concentric on each other and form a tubular body, the

outer surface thereof being the outer surface of third connecting means

215 (FIGS 17,1825,26).

{0131} The all suggested apparatus operates according to a method for

delivery and fixation of a graft or stent-graft to the wall of an aorta 300

from within the latter, this method being also a subject-matter of the

present invention (FIG.27).

{0132} This method comprises the following successive steps: I)

assembling the device for delivery and fixation of a graft or stent-graft

from the suggested kit of standardized elements, II) preparing a graft or

stent-graft for delivery and its securmg on a cartridge or a holder of the

endovascular apparatus, iii) bringing the endovascular apparatus into

operative position, iv) setting in motion the U-shaped staples and

securing the graft or stent-graft, v) detaching the delivered and sutured

graft or stent-graft from the endovsacular apparatus, and vi) removing

endovasular apparatus from the blood vessel (FIG.27). {0133} The principles of operations of the suggested apparatus may be

Illustrated on operation of Its third embodiment. At the first step the

device 201 for delivery and fixation of a graft or stent-graft adapted for

anthropometric conditions of a specific patient and intended for

performing a surgical operation to deliver a graft or stent-graft and fix it

to the walls of a blood vessel, substantially the aorta 300 (FIGS. 17 - 27),

is assembled from kit 21 of standardized elements.

{0134} At the next step the graft or stent-graft is prepared for delivery,

mounted and secured on the surface of this endovascular apparatus 201

detachable cartridge 203 or holder 207, as well as crimped to an assigned

diameter (FIGS.17, 18).

{0135} Then the endovascular apparatus 2øl is brought Into operative

position, mserted Into a corresponding blood vessel and brought to the

securing point in such a way, that Its detachable cartridges 203 are

located near corresponding suturing points. Thereupon U-shaped staples

205 are set in motion. This is achieved via means for imparting

progressive motion - flexible pushers 225 to the staples 205, and these

means are, in their turn, actuated via the third control means 221 and third

connecting means 215 associated with these means 225 for imparting

progressive motion. As a result, pointed ends of each U-shaped staple 205 205 enter the forming grooves 239, 241 on the curvilinear guiding surface

237 of a corresponding detachable cartridge 203, curl 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 the curvilinear guiding surface 237 of a corresponding detachable

cartridge 203, repeating this rotation. As a result, the graft or stent-graft

wall gets sutured, via wire spirals formed from U-shaped staples 205, to a

corresponding portion of the blood vessel, and the U-shaped staples 205

themselves entirely emerge from recesses in detachable cartridges 203

and separate from these cartridges.

[0136] Then the delivered and sutured graft or stent-graft is detached

from the endovascular apparatus 201, the endovascular apparatus for

delivery is brought into inoperative position and removed from the graft

or stent-graft and from the blood vessel.

[0137} 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 wall 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

oscillations of blood vessel walls and shaking of a patient's body during

his movement.

[0138} 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 skilled in the art.

Accordingly, the preferred embodiments of the Invention as set forth

herein are intended to be illustrative, 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. An endovascular apparatus system for delivery and fixation to the

walls of blood vessels, substantially the aorta, of endovascular devices,

substantially grafts or stent-grafts, the apparatus being assembled from a

kit of elements, comprising: a) a tubular body configured for positioning within a vessel, this tubular body being rigid in longitudinal direction and flexible in lateral direction; b) at least one detachable cartridge for receiving at least one fastener means, this detachable cartridge being disposed near the free end of this tubular body and provided with means for retaining therein the fastener means, for imparting thereto progressive motion and for forming said fastener means during its extension from said cartridge; c) at least one fastener means, substantially a U-shaped staple, located in said at least one detachable cartridge, substantially lengthwise of its longitudinal axis, with free pointed ends facing said means for forming, the U-shaped staple being located in the cartridge so as to perform progressive motion therefrom and be formed during this extension; d) a confrol mechanism provided at least with one first confrol means, at least one second control means and at least one thid control means, this control mechanism being disposed at the end of the tubular body opposite to said at least one detachable cartridge and is connected with the cartrige via this tubular body and a bearing member located within this body, this bearing member being rigid in longitudinal direction and flexible in lateral direction, said first control means serving to confrol the securing of a delivered graft or stent-graft on the apparatus, said second control means serving to control the detachment of the delivered graft or stent-graft from the apparatus, and said third confrol means serving to control the extension of said at least one fastener means from at least one detachable cartridge,

whereby it is possible to assemble from said kit, as from a construction

kit for children, at least one apparatus adapted for anthropometric

conditions of a specific patient and intended for performing a surgical

operation for deliver of a graft or stent-graft and Its endovascular fixation

to the walls of a blood vessel, substantially the aorta, on the basis of

modern methods of minimally invasive surgery.

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

endovascular apparatus additionally comprises a holder for at least one

detachable carfridge, this holder being disposed near the free end of said

tubular body and provided with members for securing this at least one

detachable cartridge and with means for securing a delivered graft or

stent-graft.

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

comprises a first and second supporting bushes and a pressure bush,

arranged in succession one after another m alignment with said tubular

body, as well as an axial rod rigidly connecting the first and second

supporting bushes, the second supporting bush being connected with the

body of said control mechanism via a bearing member shaped as a link

passing via a through axial hole of said pressure bush, said link being

located within the tubular body and concentric thereon.

4. An endovascular apparatus according to claim 3, wherein said holder is

provided at least with two detachable cartridges secured by their ends on

said first and second supporting bushes.

5. An endovascular apparatus according to claim 4, wherein said holder is

provided with members for securing at least two detachable cartridges, as

well as with means for securing a delivered graft or stent-graft located

substantially on said first supporting bush.

6. An endovascular apparatus according to claim 1, wherein said at least

one detachable cartridge comprises a means for retaining therein at least

one fastener means, substantially U-shaped staple, this means for

retaining being disposed lengthwise of the cartridge and containing

substantially a sliding lid.

7. An endovascular apparatus according to claim 1, wherein said at least

one detachable carfridge includes at least one means for imparting

progressive motion to said fastener means, substantially U-shaped staple,

and this means contains a flexible pusher, flexible in lateral direction and

rigid in longitudinal direction and connected by one its end with said

pressure bush.

8. An endovascular apparatus according to claim 1, which is provided at

least with four detachable cartridges evenly arranged around said holder,

all detachable cartridges together with their sliding lids and flexible

pushers being identical and Interchangeable.

9. An endovascular apparatus according to claim 1, wherein said tubular

body includes a first connecting means for operative connection of said

first control means with means for securing a delivered graft or stent-graft

on the apparatus, a second connecting means for operative connection of

said second confrol means with means for detaching a delivered graft or

stent-graft from the apparatus, as well as a third connecting means for

operative connection of said third confrol means with means for

imparting progressive movement at least to one fastener means.

10. An endovascular apparatras according to claim 9, wherein said first

connecting means for operative connection of said first control means

with said means for securing of a delivered graft or stent-graft on the

apparatus is mechanical.

11. An endovascular apparatus according to claim 9, wherein said first

connecting means for operative connection of said first confrol means

with said means for securing a delivered graft or stent-graft on the

apparatus Is hydraulic.

12. An endovascular apparatus according to claim 9, wherein said second

connecting means for operative connection of said second control means

with said means for detaching a delivered graft or stent-graft from the

apparatus is mechanical.

13. An endovascular apparatus according to claim 9, wherein said second

connecting means for operative connection of said second control means

with said means for detaching a delivered graft or stent-graft from the

apparatus is hydraulic.

14. An endovascular apparatus according to claim 9, wherein said third

connecting means for operative connection of said third control means

with said means for imparting progressive motion at least to one fastener

means is mechanical.

15. An endovascular apparatus according to claim 9, wherein said third

connecting means for operative connection of said third confrol means

with said means for imparting progressive motion at least to one fastener

means is electrical.

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

control mechanism at least with one first control means, at least one

second confrol means and at least one third confrol means may be

supplied with detachable additional sections for receiving additional

control means.

17. A detachable cartridge according to claim 1, having a body provided

with a recess for receiving at least one fastener means, substantially U-

shaped staple, slots for mounting said sliding lid, as well as a longitudinal

duct for receiving at least one said flexible pusher, the U-shaped staple

being disposed in said recess in frictional contact with the sliding lid to

prevent its falling out of this recess.

18. A detachable cartridge according to claim 17, which has a body with

a recess at least for one fastener means, substantially U-shaped staple,

this recess is symmetric about the longitudinal axis of said cartridge and

parallel with its outer surface, the cartridge being provided with a means

for forming said U-shaped staple during its extension from said recess,

and this means is a curvilinear guiding surface connecting the bottom of

said recess for U-shaped staple with the outer surface of the carfridge.

1 . A detachable cartridge according to claim 18, which is provided with

a means for foiming the U-shaped staple during its extension from this

cartridge, and this means is a curvilinear guiding surface connecting the

bottom of said recess for a U-shaped staple with the outer surface of the

cartridge, said curvilinear guiding surface being provided with forming

grooves.

20. A detachable cartridge according to claim 19, wherein said forming

grooves diverge at an acute angle from one another and from the

longitudinal axis of this detachable cartridge.

21. A detachable cartridge according to claim 20, wherein at least one

fastener means, substantially a U-shaped staple, has pointed free ends and

is located in said recess of the body of this detachable cartridge in such a

way that its pointed ends face the corresponding forming grooves on said

curvilinear guiding surface.

22. A detachable cartridge according to claim 21, wherein said forming

grooves diverge at an acute angle from one another and from the

longitudinal axis of this cartridge to provide helical oppositely directed

curling of pointed ends of a corresponding U-shaped staple during its

movement over the body recess and forming grooves of said curvilinear

guiding surface of the detachable cartridge.

23. A detachable cartridge according to claim 1, shaped substantially as a

polyhedral prism with two skewed side faces inclined at an acute angle to

one another, the vertex of this acute angle being disposed on the

longitudinal axis of said holder for at least one carfridge.

24. A detachable cartridge according to claim 23, shaped substantially as

a polyhedral prism provided with means for connection with said holder

for at least one detachable cartridge.

25. A detachable cartridge according to claim 24, shaped substantially as

a polyhedral prism provided with means for connection with said holder

for at least one detachable cartridge, and these means substantially

contain arms with holes which project from both bases of said polyhedral

prism and are integral with this polyhedral prism.

26. A holder according to claim 1, which is provided with means for

securing a delivered graft or stent-graft shaped substantially as movable

radial tongues evenly arranged on the at least one cartridge or on the first

supporting bush at the free end of this holder to extend from this carfridge

or bush on operating said first control means of said control mechanism.

27. A holder according to claim 26, which is provided with means for

detaching a delivered graft or stent-graft shaped substantially as movable

radial tongues evenly arranged on the at least one cartridge or on the first

supporting bush at the free end of this holder to sink into the body of this

at least one cartridge or this bush on operating said second control means

of said eontrol mechanism.

28. A method for delivery and fixation of a graft or stent-graft to the waH

of a blood vessel from within the latter comprising the following

successive steps:

I) assembly from the suggested kit of standardized elements, of a device for delivery and fixation of a graft or stent-graft adapted for anthropometric conditions of a specific patient and intended for performing a surgical operation to deliver a graft or stent-graft and fix it to the walls of a blood vessel, substantially the aorta; ii) preparing the graft or stent-graft for delivery, its mounting and securing on the surface of said at least one detachable cartridge or on the surface of said first supporting bush of the endovascular apparatus for delivery, as well as crimping the graft or stent-graft to an assigned outer diameter;

iii) bringing the endovascular apparatus for delivery into operative position, inserting it into a corresponding blood vessel and bringing to the suturing point in such a way that said detachable cartridges are located near corresponding suturing points;

iv) setting in motion said U-shaped staples via said means for imparting progressive motion to these staples, said means being, in their turn, actuated by the third control means and third connecting means associated therewith, whereby pointed ends of each U- shaped staple enter the forming grooves of said curvilinear surface of a corresponding detachable cartridge, curl 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 curvilmear guiding surface, repeating this rotation, if it is permitted by the assigned 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 the blood vessel wall, and said U-shaped staples entirely emerge ^'from the recesses of

corresponding cartridges and separate from these cartridges;

detaching a delivered graft or stent-graft from the endovascular

apparatus, and

bringing the endovascular apparatus for delivery into inoperative

position and its removal from the graft or stent-graft and from the

blood vessel.