WO2004034868A2 - Method and apparatus for open aortic repair by intravascular devices - Google Patents

Abstract

The present invention relates to methods and apparatus for locating and securing intravascular devices, substantially grafts and stent-grafts (3), through a duct specially created by surgical means for access to the lumen of a blood vessel. There is a method for securing an intravascular device to the wall of a blood vessel in combination with a new and improved stapler (2). The stapler (2) comprises a hollow body (10), at the proximal end thereof there are mounted to a die (20) and die lid (22), and at the distal end, a holding handle (16) and a control lever (18) pivotally connected with this holding handle (16) and operatively connected, via a movable pressure member (34) with a tip located inside the body (10) and the die (20). The movement of the control lever (18) is converted into radial forces necessary for punching the wall of the intravascular device and surrounding blood vessel wall and fixing a fastener means (42).

Description

METHOD AND APPARATUS FOR OPEN AORTIC REPAIR BY INTRAVASCULAR DEVICES

This patent application is compiled on the base of the two Israeli

Patent Applications: LL 152280 from 14.10.2002 and IL 154815 from

09.03.2003.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to medical techniques, in particular,

to apparatus and methods used to prevent an aorta rupture by means of

grafts or stent-grafts. More particularly, the present invention relates to

methods and apparatus for securing intravascular devices, such as grafts

or stent-grafts, to the walls of blood vessels in direction from the inside of

these vessels towards their outer surface. [0003] 2. Description of Related Art

[0004] An aortic aneurysm (or its rupture) is a . most common form of

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

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

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

resulting from the weakening of the artery's wall due to disease or other

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

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

death.

[0005] 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 the iliac arteries. The iliac

arteries, in turn, supply blood to the lower extremities and perineal

region. [0006] It is common for an aortic aneurysm to oceur in that portion of

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

the iliac arteries. An aortic aneurysm larger than about five centimetre in

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

aneurysrns smaller than five centimetre because no statistical benefit

exists in performing such procedures.

j

[0007] Aneurysrns 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 an aortic

aneurysm is extremely high, there is also considerable mortality and

morbidity associated with open surgical intervention to repair an aortic

aneurysm. This intervention involves penetrating the abdominal wall 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 aorta at the aneurysm.

[0008] Besides synthetic grafts, there are developed and widely used all

over the world particularly to prevent the rupture of aorta wall

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

located similarly to stents. The fixation of a stent-graft on the aorta walls

is performed due to resilient forces of the material of the stent-graft itself

usually having elastic members which bear up against the blood vessel

wall or hook thereto. If the forces of resilient or elastic members of the

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

may be displaced from a given position and moved along the aorta due to

the blood flow and peristelsic oscillations of the walls of this blood

vessel, which is very dangerous to the patient.

[0009] 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 mfra-abdominal surgery. It is, therefore, desirable to

reduce the mortaUty and morbidity associated with mfra-abdominal

surgical intervention.

[0010] In recent years, the common repair means is to deploy of a stent-

graft within the lumen of the affected aorta in the region of the aneurysm.

These methods and devices have been developed to attempt to treat an

aortic aneurysm without the attendant risks of mtra-abdominal surgical

intervention. Among them are inventions disclosed and claimed in

Parodi, Juan C. et al., WO 010487A1 for Graft Device for Treating

Abdominal Aortic Aneurysrns and its patent family, including U.S.

5219355, 5522880, 5571171, 5643208, 5683452, 5693087, 6102942,

EP 461791A1, EP 809980A3, EP 903118A2, EP 903119A3, EP

903120A3 etc.

[0011] Parodi discloses a stent-graft device for locating inside an aorta

affected by an aneurysm causing the aorta to have an inner diameter

smaller than the sum of inner diameters of the iliac arteries. The graft has

an upper main tubular portion dividing into two pending graft limbs

capable of accommodating together within the restricted inner diameter

of the aorta without the restriction of the aorta affecting the diameter of the limbs. The limbs having respective distal end portion having

diameters larger than the diameters of the graft limbs so as to be

accommodated and retained within the iliac arteries. Parodi' s stent-graft

is inserted using a tubular device also disclosed in his patent.

[0012] In other Parodi's patents there are disclosed stent-graft designs

having a metal wire frame collapsible to a miiiimal 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. 5522880, U.S. 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. 5911733 Endovascular Expander of a Non-

migrant Positioning, EP 948945A2 Endovascular Prosthesis with

Fixation Means. [0013] The problem of fixation of stents and stent-grafts inside the aorta

and iliac arteries is PARTIALLY solved by other inventors likewise.

[0014] Lindenberg, Josef in EP 711135A1 discloses a stent with an

improved anchorage in a vessel. The stent can be expanded from a

radially contracted insertion state into a radially expanded positioning

state such that in the radially expanded state at least one end has a larger

radial extension than the remaining main body of the stent.

[0015] Samuels in U.S. 5423851 discloses a method and apparatus for

affixing an endoluriiinal device to the walls of tubular structures within

the body which utilizes incremental inflation of a balloon cuff to deploy

radially projecting barbs attached to the cuff within plurality of recesses.

[0016] Kugler, Chad disclose in their patent WO 19943A1 a stent-graft

comprising radially expandable portions attached to one another and

anchored to the aorta walls by a radial force. This stent-graft can bend to

match the aorta longitudinal section by relative angular displacement of

its portions. [0017] Houser, Russel in WO 15144A1 discloses a system and

components for treating aortic aneurysrns includes a reinforcing graft and

combinations of fittings and rings for securing the graft to a host vessel,

to branch vessels, for example the iliac, and renal arteries.

[0018] Edwin, Tarun et al., discloses in EP 868154A1 a structurally

supported graft having a support structure with strain relief sections

containing an internal surface, an external surface, or a wall thickness of a

tubular graft member. The structural support forms a spiral about the

tubular graft.

[0019] Numerous suggestions of stent-graft inventors present various

hooks and anchor members, integral or not integral with the stent-graft

frame to fixate the latter inside the aorta or iliac arteries. Such

suggestions are disclosed in U.S. 6015431, EP 747020A2, EP 701800A1,

EP 657147 A2, EP 466518A2, U.S. 5669936, U.S. 6004347, U.S.

5733325, U.S. 5104399, U.S. 6030413.

[0020] All the above-mentioned inventions have, in our opinion, a

common drawback, which consists in the fact that the stent-grafts fixation

on the inner walls of the aorta and iliac arteries is not reliable enough and bring to many complications. Therefore, under the action of blood flow

and peristaltic oscillations of artery walls, stent-grafts are displaced from

their proper positions, which may have grave consequences for the

patient and result in his death because of the aorta rupture.

[0021] 3. The Prior Art

[0022] Closest to the present invention are inventions disclosed and

claimed in Taheri, Syde, U.S. 5843169 for Apparatus and Method for

Stapling Graft Material to a Blood Vessel Wall while Preserving the

Patency of Orifices and inventions disclosed and planned by Tanner,

Howard, in U.S. 5944750 for Method and Apparatus for the Surgical

Repair of Aneurysrns, U.S. 5957940 for Fasteners for Use in the Surgical

Repair of Aneurysrns and U.S.5997556 for Surgical Fastener.

[0023] Taheri, Syde in U.S. 5843169 discloses an apparatus for stapling

graft material to a blood vessel wall comprising a stapling device, a

balloon catheter, a sheath, and an inflation means. [0024] The apparatus design suggested by Tahery is, in our opinion,

inoperative as the radial force generated by a balloon is inadequate to

insert a securing member shaped as a nail into the wall of the aorta or

artery. It is especially unlikely if the wall of the aorta or artery is covered

with calcium plaques.

[0025] Tanner, Howard in U.S. 5944750 discloses an attachment

assembly and repair graft for securing to repair a vessel having an

aneurysm therein. The attachment assembly comprises an attachment cuff

such that the graft is not dimensionalfy dependent upon the size of the

vessel. The apparatus also comprises a visualization apparatus for real

time direct viewing of an interior of a vessel. A penetration apparatus is

disclosed for use in forming treatment specific holes in a potentially

calcified vessel wall, which facilitates thereafter the securing of the graft

and attachment assembly to the vessel wall. An introducer sheath device

is also disclosed that comprises a sealing assembly for preventing the loss

of blood from the vessel during the insertion and subsequent removal of

surgical components during the surgical procedure. [0026] In U.S. Pat. 5957940 and U.S. Pat. 5997556, H. Tanner also

discloses fasteners for use during a surgical procedure for securing

surgical components to the blood vessel wall under a compressive force.

According to the inventions, the fastener assemblies are shaped as a

coiled spring or spiral or a plurality of entwined coil springs or ring type

fasteners including a plurality of rings.

[0027] All the described inventions by Howard Tanner have, in our

opinion, a complicated and not adequately reliable design and limited

functional possibilities. So, in particular, the apparatus for setting the

securing elements cannot be brought in operative position inside iliac

arteries having a small lateral diameter. Because of limited space it is

impossible to bend the end of the apparatus working head for setting the

securing elements in the stent-graft wall. The efficiency of this apparatus

for drilling holes in the walls of the stent-graft, aorta and iliac arteries is

doubted, especially if these walls are calcified and covered by calcium

plaques. In general, we tlaink that the apparatus presented by Howard

Tanner can be used only inside the aorta and not inside iliac arteries. As

far as the suggested securing elements are concerned, we believe that

their fixation in the inner walls of the aorta and iliac arteries is not reliable enough. Therefore, under the action of blood flow and peristaltic

oscillations of artery walls, the stent-graft may be displaced from its

proper position, which may have grave consequences for the patient and

may result in his death due to the aorta rupture.

[0028] And finally, there are are known devices developed in France by

Thierry Richard, Eric Perouse, such as "Surgical staple inserter", see U.S.

Pat. 5346115; WO 9217117; EP 0533897 and "Surgical staple for tissue",

see Pat. FR 2746292.

[0029] U.S. Pat. 5,346,115; WO 9217117; EP 0,533897 describes a

surgical staple inserter for joining two ducts such as a blood vessel and

blood prosthesis. The staple inserter ejects staples in a radial direction

relative to the axis of the ducts. In one embodiment, it includes a staple

holder surrounded by the prosthesis and containing a series of staples

arranged in at least one ring. All the staples are ejected simultaneously.

The staple inserter also includes an anvil outside the organic duct, and a

device for spacing apart the anvil and the staple holder in relation to their

relative working position. Projections hold the prosthesis in place during

the insertion of the staple holder into the ducts. [0030] One of the drawbacks of this device is the complexity of its

design, but its chief drawback is that it does not allow to bend the ends of

staples when they are extending from the device body outwardly, through

the prosthesis and the blood vessel wall. Therefore it is necessary to

provide the device with anvils arranged outside the operated blood vessel,

and this makes both the device itself and the whole operation for setting a

stent-graft more complicated and expensive.

[0031] Pat. FR 2746292 describes the surgical staple, which has a circular

spiral formed of metallic wire. It extends on a complete spiral, which is

augmented over part of its length. The staple can have a barbed end. The

device for this staples inserting comprises a guide tube, extending

towards the front by an inwardly curved section with a guide channel. At

least a section of metal wire moves in the guide tube. A pusher moves the

wire section towards the distal end of the guide tube.

[0032] The device has several drawbacks. It is rather difficult to set the

staples as the device must be positioned very accurately relative to the

prosthesis wall, it is impossible to set several staples simultaneously, and considerable projection of parts of staples inside the prosthesis may result

in an accelerated thrombogenesis in this prosthesis lumen.

[0033] On the whole, today no methods and apparatus for grafts and

stent-grafts fixation to the walls of a blood vessel from inside this vessel,

that are developed, brought to mass production and use in real practice,

which are known to the authors of the present invention.

[0034] An object of the present invention is to provide reliable and

relatively simple means for securing a graft, stent-graft or other

intravascular devices to the wall of the aorta, iliac arteries or other

arteries, in particular, a new and improved methdd for stapling and

stapling apparatus based on this method.

[0035] Another object of the present invention is to provide suturing of a

prosthesis to a blood vessel over the whole perimeter of connection, as

well as security and tightness of this connection even in such hard to

reach spots, as the aorta neck or in the area immediately under renal

arteries. SUMMARY OF THE INVENTION

[0036] The present invention includes a method for mttaluminal fixation

of intravascular devices, such as grafts, stent-grafts.

[0037] The method includes several successive steps. At the first step a

special stapler is prepared for the operation. For this purpose, the state of

its loading with fastener means is checked (loaded or not), and if

necessary, it is loaded. Then a corresponding intravascular device,

substantially graft or stent-graft, is fitted over the body of this stapler,

J partly reversing, if necessary, one end of this intravascular device.

Further, the fitted intravascular device is secured on the stapler body via

a means for its temporary fixation. At the next step there is created, by

surgical means, a duct for access to the lumen of the operated blood

vessel, substantially the aorta, directly through the wall of this blood

vessel. Then, through the duct to the lumen of the operated blood vessel,

substantially the aorta, there is inserted a special stapler with a

corresponding intravascular device, substantially a graft or stent-graft,

fitted and fixed thereon, and this intravascular device is set in a desired

position. Thereupon the stapler is brought into operative position necessary to secure the first end of this intravascular device, in this case,

a graft, on the wall of a blood vessel, substantially the aorta. Then there is

checked the matching of mutual location of the first end of the

intravascular device, the place of its supposed attachment to to the blood

vessel wall, as well as of the stapler actuator with fastener means located

near its free end.

[0038] Further, in the stapler actuator there are created radial forces

sufficient to act on the fastener means. Owing to these forces, the fastener

means extending from the actuator in radial direction, punch the wall of

the intravascular device and the surrounding blood vessel wall in such a

manner that the distal ends of these fastener means partly project outside

the blood vessel and bend over on its outer surface to form a rigid

connection of the first end of this intravascular device with the blood

vessel wall. Then the stapler actuator is withdrawn from the first end of

the wall of this intravascular device, so that the fastener means remain

fixed in the wall of this intravascular device and in the blood vessel wall

to secure the first end of the intravascular device with the corresponding

blood vessel portion and thus prevent any its displacement relative to this

blood vessel. Further, the stapler is brought into inoperative position necessary for its free removal and is removed from the intravascular

device and from the blood vessel.

[0039] At the next step, an incision is made in the intravascular device

(stent or stent-graft) for access to its lumen. Then another special stapler

for securing the second end of this intravascular device to the wall of a

given blood vesel (aorta) is inserted through the duct created before and

through the incision into the lumen of the intravascular device (graft or

stent-graft). This stapler is brought into operative position, whereupon its

actuator with fastener means located in a die at its free end is brought to

the wall of this intravascular device, at the point of securing its second

end to the blood vessel wall. Then there is checked _j the matching of the

location of the second end of this intravascular device, the spot of its

supposed securing to the blood vessel wall, as well as of the stapler

actuator with fastener means. On creating in the actuator of this stapler an

axial force sufficient to act on fastener means, these fastener means,

extending from the actuator in radial direcion, punch the wall of this

intravascular device and the surrounding blood vessel wall in such a

manner that the distal ends of these fastener means partly project outside

the blood vessel and bend over on its outer surface, to form a rigid

connection of the second end of this intravascular device with the blood vessel wall. Then the actuator of the other stapler is withdrawn from the

wall of the intravascular device, so that the fastener means remain fixed

in the the wall of this intravascular device and in the blood vessel wall, to

secure the second end of this intravascular device with the corresponding

portion of the blood vessel and thus prevent any its displacement relative

to this blood vessel. Next, the stapler is brought into inoperative position

necessary for its free removal from the intravascular device and is

removed therefrom and from the blood vessel.

[0040] At the final step, the incision in the intravascular device and duct

for access to te lumen of this intravascular device an4 to the lumen of the

operated blood vessel are closed by surgical means.

[0041] Owing to these manipulations, there is formed a secure multiple-

point connection of an intravascular device with the blood vessel wall

which prevents displacement of this intravascular device from a given

position due blood flow and peristelsic oscillations of the blood vessel

walls. [0042] According to the claimed method, it is possible to secure an

intravascular device, such as a graft or stent graft to a blood vesel wall via

at least one claimed stapler and using at least two fastener means,

simultaneously at least at three points. This is performed substantially

near one of the free ends of this intravascular device.

[0043] According to the second embodiment of the claimed method, the

ends of an intravascular device, such as a stent graft having a broad

proximal part and bifurcated distal part, is secured to the wall of a blood

vessel (aorta) via a set of at least two staplers and using in each of them

simultaneously at least two fastener means. The set contains at least one

first stapler for securing the broad proximal part of the stent-graft to the

aorta wall and at least one second stapler for securing to the bifurdates

distal part of the aorta the distal part of this stent-graft. In this case, the

proximal end of the stent-graft having a broad proximal part is secured to

the wall af a blood vessel (aorta) in the area of aorta neck via the first of

staplers comprised in the set of staplers, and using simultaneously at least

two said fastener means.

[0044] The distal end of a stent-graft having a bifurcated distal part is

secured to the aorta wall via the second of staplers comprised in the set, and using simultaneously at least two fastener means. It is secured near

the free end of the first or second branch of the bifurcated distal part of

this stent-graft.

[0045] At last, according to the claimed method, the stent-graft may be

secured to the aorta using at least two fastener means near the free end of

both branches of the bifurcated distal part of a stent-graft.

[0046] The claimed invention also includes a stapler for mfraluminal

fixation of intravascular devices, substantially grafts or stent-frafts,

located inside blood vessels.

[0047] This stapler contains a substantially cylindrical hollow body

having an inner axial cavity, a proximal end with a holding handle

extending therefrom a side at a certain angle, from about 30 degrees to

about 90 degrees, and a control lever pivotally mounted on this handle. At

the proximal end of this hollow body there is rigidly mounted an actuator

containing a die and die lid aligned with this body and arranged

successively in direction to the free end of the stapler. [0048] The die of the claimed stapler is intended for locating fastener

means, substantially U-shaped staples. It is shaped as a barrel having a

proximal end, distal end, a substantially cylindrical generatrix and an

inner axial cavity open on the side of the barrel distal end and terminating

in a bottom at the barrel proximal end. This bottom has a through axial

hole, through evenly disposed radial slots, and on their end face presented

to the die lid — recesses with grooves for locating fastener means,

substantially U-shaped staples. The recesses with grooves have

substantially the same depth relative to the bottom end face. In another

embodiment, these recesses with grooves have different depth relative to

the end face of this die bottom. The recesses with grooves may have at

least two different depths relative to the die bottom, and the recesses with

grooves of different depth alternate.

[0049] The fastener means, substantially U-shaped staples, are arranged

radially in the die grooves to extend radially from these grooves due to

radial forces. The free ends of U-shaped staples are located on either side

of means for setting apart these fastener means, the latter being disposed

along the axes of these grooves, coaxially with radial slots, right up to the

cylindrical generatrix of the die. [0050] The means for setting apart the ends of fastener means are

substantially V-shaped and have sides which are substantially curved,

concave and diverge from one another in direction from the center of the

die towards its cylindrical generatrix. This allows to bend outwardly the

free ends of fastener means when they are extending from the die due to

radial forces. These means for setting apart the ends of fastener means

may also have sides which are substantially radial' concave and diverging

from one another in direcrion from the center of the die to its cylindrical

generatrix.

[0051] The die lid has a through axial hole, substantially cylindical

generatrix, proximal and distal end faces. The the body of this die lid is

provided with radial slots evenly arranged near the distal end face and

passing onto its cylindrical generatrix, as well as with means for holding

the free ends of U-shaped staples and means for separating the middles of

of these U-shaped staples from the stapler at the end of their working

stroke. All these means are disposed in the lid body near the points of

intersection of radial slots with the distal end face and cylindrical

generatrix. The means for holding the free ends of U-shaped staples are

torsion spring members located near the points of intersection of radial slots with the distal end face and and cylindrical generatrix of the die lid.

The means for separating the middles of U-shaped staples from the

stapler at the end of their working stroke are shaped as recesses located

near the points of intersection of radial slots with the distal end face and

cylindrical generatrix of this die lid. For checking the state the stapler

fastener means (whether the stapler is loaded or not) the die lid may be

made of a transparent material.

[0052] The stapler further contains a pressure rod located inside the

hollow body and having a longitudinal axis, a proximal end and a distal

end. The pressure rod is operatively connected via its distal end with the

control lever, spring-loaded, has a thrust collar near jits distal end and is

reciprocable inside the hollow body of the stapler. The proximal end of

this pressure rod is shaped substantially as a cone and is disposed in the

inner axial cavity of the die. The proximal end of this pressure rod has an

angle at cone vertex from about 3 degrees to approximately 35 degrees,

substantially from about 10 degrees to approximately 20 degrees.

[0053] The stapler further contains means for thransmitting axial force

from the pressure rod to fastener means, substantially U-shaped staples,

and for converting this axial force into radial forces applied to each of these U-shaped staples. These means are shaped as curved L-shaped

levers. The curved L-shaped levers are pivotally mounted by the end of

its long arm near the free end of the hollow body and evenly disposed in

the inner axial cavity of the die in such a way, that their short arms bent

outward relative to the longitudinal axis of this die are disposed in

corresponding through radial slots at the bottom of this die. The bent L-

shaped levers are configured to periodically engage via the inner surface

of their long arm with the conical proximal end of the pressure rod, and

via its free ends of short arms bent outward - with the middles of U-

shaped staples. To this end, the curved L- shaped levers are pivotally

mounted via the ends of their long arms on a ring located inside the inner

axial axial cavity of the die, in the clearance between the free end of the

hollow body and the flange of an additional bush rigidly secured inside

this hollow body. The flange has evenly arranged radial slots, and in each

of them there is movably mounted a corresponding curved L-shaped

lever.

[0054] In another embodiment, the curved L-shaped levers are pivotally

mounted via the ends of their long arms on a ring disposed in the inner

axial cavity of the die, in the clearance between the free end of the hollow

body and the inner ribs of this die extending from the wall of its inner axial cavity in direction to the longitudinal axis of the die. In this case, the

ribs have evenly disposed radial slots, and in each of the latter there is

located a corresponding curved L-shaped lever.

[0055] At last, the die, die lid and fastener means, substanially U-shaped

staples, located in the die grooves, form, in combination, a single set of

the stapler actuator which is adapted to be detached from the body of this

stapler and then replaced by other, similar interchangeable sets.

[0056] All the described stapler embodiments are provided with a means

for temporary fixation outside, on the body of this stapler, of deHvered

intravascular devices, substantially grafts or stent-grafts. This means

substantially contains a lock screw with a thrust head located in the distal

part of this body in angnment with the pressure rod and on the other side

relative to the working end of the control lever, as well as fastener means-

U-shaped staples operatively connected with this lock screw via the

working end of this control lever and pressure rod. [0057] In its each embodiment, the claimed stapler is provided with an

additional means serving to prepare hyperfine and/or corrugated

intravascular devices for temporary fixation outside the body of this

stapler. This additional device contains a stepped rod, thin-wall bush and

pressure bush. The stepped rod has a first end and a second end, and

contains on its outer surface several successively arranged cylindrical

portions forming steps of increasing diameter in direction from the first

end of this rod to its second end. These cylindrical portions are linked

together via conical transition portions, the outer surface whereof is

inclined at an acute angle in direction from the first end of this stepped

rod to its second end. The last portion of the rod at its second end has an

outer diameter greater than that of the next to last step of the rod by a

value, exceeding four thicknesses of this intravascular device. Besides,

the inclination angle of the outer surface of the conical transition angle

between the next to last and the last steps located near the second end of

the stepped rod is twice that of inclination angles of outer surfaces of the

conical transition portions between tha remaining steps of this stepped

rod. [0058] The additional device further contains a thin-wall bush the inner

diameter whereof is greater than the outer diameter of the next to last step

of the stepped rod by a value exceeding two thicknesses of the walls of

the intravascular device, and the outer diameter of this thin-wall bush is

smaller than the outer diameter of the last atep of this rod at its second

step by a value exceeding two thicknesses of the walls of the

intravascular device. The thin-wall bush has a thrust collar at one its end.

[0059] And at last, the additional device contains a pressure bush with a

thrust collar at one its end, the inner diameter of the bush being somewhat

greater than the outer diameter of the last stage of the stepped rod at its

second end.

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 is a perspective view of a stapler apparatus according the

present invention;

[0062] FIG. 2 is the longitudinal section of the stapler, according to the

first embodiment of the present invention, with the pressure rod in initial

position;

[0063] FIG. 3 is the front view of the claimed stapler according to the

first embodiment of the present invention;

[0064] FIG. 4 is the longitudinal section of the stapler according to the

second embodiment of the present invention, with .the pressure rod in

initial position;

[0065] FIG. 5 - 7 is the first embodiment of the stapler die - its

longitudinal section, front view, local section and close-up of the groove;

[0066] FIG. 8 - 11 is the second embodiment of the stapler die - its

longitudinal section, front view, cross section, local section and close-up

of the groove; [0067] FIG. 12 - 14 is the Ud of the stapler die - its longitudinal section,

partial back view, local section and close-up of the groove;

[0068] FIG. 15 is the pressure rod, side view;

[0069] FIG. 16 is a U-shaped staple;

[0070] FIG. 17 is an L-shaped lever and diagram of its engagement with

the pressure rod;

[0071] FIG. 18 is a diagram of securing L-shaped levers on a ring;

[0072] FIG. 19 - 20 are the longitudinal and cross sections of an aditional bush;

[0073] FIG. 21 - 23 are elements of the additional device for the claimed

stapler: stepped rod, thin-waU rod and pressure bush;

[0074] FIG. 24 is a diagram of the additional device operation.

[0075] FIG. 25 - 26 are diagrams of setting a graft and stent-graft using a

set of claimed staplers. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0076] 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.

[0077] The most preferred embodiments of the stapler according to the

present invention are shown in FIG. 1, 2, 3 and FIG 4.

[0078] The present invention (FIG. 1) comprises a stapler 1 for

intraluminal fixation of intravascular devices, substantially grafts or stent¬

grafts 3 inside blood vessels .

[0079] Stapler 1 comprises a substantially cylindrical hollow body 10

(FIG. 1) having an inner axial cavity, a proximal end 12 and distal end

14 with a holding handle 16 extending therefrom aside at a certain angle,

from about 30 degrees to about 90 degrees, and a control lever 18 pivotally mounted on the holding handle 16. At the proximal end 12 of

hoUow body 10 there is rigidly mounted an actuator containing die 20 and

die Ud 22 arranged in aUgnment with this body and in succession in

direction to the free end of the stapler. On the holding handle 16 there are

mounted a stop 24 and lock 26 preventing accidental pressing on control

lever 18 (FIG. 1).

[0080] FIG. 2, 3 show the longitudinal section of stapler 1, according to

its first embodiment and its front view.

[0081] Lock 26 (FIG. 2) of stapler 1 is pivotaUy mounted on pin 28 and

loaded with a spring 30. Control lever 18 is pivotaUy mounted on pin 32.

Inside the hoUow body 10 (FIG. 2, 4 and 15) there is located pressure rod

34 having a longitudinal axis 36, proximal end 38 and distal end 40. This

pressure rod 34 is a means for transmitting the axial force from control

lever 18 to fastener means 42 (FIG. 2, 4) and for converting this axial

force into radial forces appUed to each of these fastener means 42.

Pressure rod 34 (FIG. 2, 3) is operatively connected via its distal end 40

with control lever 18, loaded by spring 44, has a thrust coUar 46 near its

distal end 40. Pressure rod 34 (FIG. 2) is reciprocable inside die 20 and die Ud 22. In the embodiment shown in FIG. 2, the stapler is provided

with curved L-shaped levers 48 fitted over ring 50 and located between

the free end of body 10 and the flange of additional bush 52. Levers 50

are movably located in the slots of the flange of additional bush 52. Die

20 is secured on body 10 via screws 54. Die 20 may be made of

transparent material.

[0082] FIG.4 shows the longitudinal section of stapler 1 according to the

second embodiment. Stapler 1 according to this embodiment differs only

in the design of die 20 and the absence of additional bush 52.

[0083] Lock 26 (FIG. 4) of stapler 1, according to the second

embodiment, is also pivotaUy mounted on pin 28 and loaded with spring

30. Control lever 18 is pivotaUy mounted on pin 32. Inside hollow body

10 (FIG. 4) there is located a pressure rod 34 having a longitudinal axis

36, proximal end 38 and distal end 40. This pressure rod 34 is a means for

ttansmitting axial force from control lever 18 to fastener means 42 (FIG.

4) and for converting this axial force into radial forces appUed to each of

these fastener means 42. Pressure rod 34 (FIG. 2, 4) is operatively

connected via its distal end 40 with control lever 18, loaded with spring

44, has a thrust coUar 46 near its distal end 40. Pressure rod 34 (FIG. 4) is reciprocable inside die 20 and die Ud 22. In the second embodiment

shown in FIG. 4, the stapler is also provided with curved L-shaped levers

48 fitted over ring 50 and located between the free end of body 10 and

inner ribs 56 of die 20 (FIG. 4). Levers 48 are movably disposed in slots

58 of inner ribs 56 of die 20 (FIG. 10). Die 20 is mounted on body 10 via

screws 54.

[0084] Die 20 of the claimed stapler serves for locating fastener means,

substantially U-shaped staples 42 (FIG. 5 - 7 and 8 - 11). Die 20,

according to the first embodimnt of stapler 1 (FIG. 5 -7) is shaped as a

barrel 60 having a proximal end 62, distal end 64, cylindrical generatrix

66 and inner axial cavity 68 open on the side of distal_j end 64 of barrel 60

and terminating in a bottom 70 at the proximal end 62 of barrel 60. This

bottom 70 has through evenly arranged radial slots 72 (FIG. 6, 7), and on

its end face 74 presented to die Ud 22 - recesses 76 with grooves 78 for

locating fastener means - U-shaped staples 42 (FIG. 6 - 7). These recesses

76 with grooves 78 are aligned with radial slots 72 and provided with

means (FIG. 14) for setting apart the ends of U-shaped staples 42-

guiding surfaces 80 arranged along the axes of grooves 78, right up to

the cylindrical generatrix 66 of die 20, and substantiaUy V-shaped . [0085] Die 20, accoding to the second embodiment of stapler 1 (FIG. 8 -

11), is also shaped as a barrel 60 having a proximal end 62, distal end 64,

cyUndrical generatrix 66 and inner axial cavity 68 open on the side of

distal end 64 of barrel 60 and terminating in bottom 70 at the proximal

end 62 of barrel 60. This bottom 70 has through evenly arranged radial

slots 72 (FIG. 9, 11), and on its end face 74 presented to die lid 22 -

recesses 76 with grooves 78 for locating fastener means - U-shaped

staples 42 (FIG. 6 - 7). These recesses 76 with grooves 78 are aligned

with radial slots 72 and provided with means (FIG. 11) for setting apart

the ends of U-shaped staples 42 - guiding surfaces 80 located along the

axes of grooves 78, right up to the cyUndrical generatix 66 of die 20 and

being substantiaUy V-shaped. The die according to the second

embodiment differs from the die according to the first embodiment is that

it is provided with inner ribs 56 with slots 58 for movably locate therein

levers 48 (FIG. 8 - 9).

[0086] In the embodiments shown in FIG. 5 - 7 and 8 - 11 recesses 76

with grooves 78 have substantiaUy the same depth relative to the end face

74 of bottom 70 of die 20. Thereby there is provided an even arrangement

of U-shaped staples 42 in one cross section of graft or stent-graft 3. In another embodiment of die 20, (not shown in the drawings) recesses 76

with grooves 78 have substantially different depths relative o end face 74

of bottom 70 of die 20. Recesses 76 with grooves 78 may have at least

two different depths relative to end face 74 of bottom 70 of die 20. In

this case, recesses 76 with grooves 78 of different depths alternate.

Thereby there is provided uneven arrangement of U-shaped staples 42

located in two paraUel cross sections of graft or stent-graft 3, which, in

the opinion of the inventors, provides more secure connection of graft or

stent-graft 3 with a blood vessel.

[0087] U-shaped staples 42 are disposed radially in grooves 78 of die 20

to extend radiaUy from these grooves due to radial forces (FIG. 2, 4). In

this case, the free ends of U-shaped staples 42 are located on either side

of means for setting apart the ends of these fastener means - guiding

surfaces 80 located along the axes of grooves 78, in alignment with radial

slots 72, right up to the cylindrical generatrix 66 of die 20.

[0088] SubstantiaUy V-shaped guiding surfaces 80 have guiding sides

which are substntiaUy curved, concave and diverging from one another in

direction from the center of die 20 to its cyUndrical generatrix 66 (FIG.

11). This aUows to bend outwards the free ends of U-shaped staples 42 when they are extended from die 20 due to radial forces. Guiding surfaces

80 may also be radial, concave and diverging from one another in

direction from the center of die 20 to its cyUndrical generatrix 66 (FIG.

7).

[0089] Die Ud 22 (FIG. 12 - 14) has a through axial hole 82, substantiaUy

cyUndrical generatrix 84, proximal and distal end faces, 86 and 88

respectively. In the body of the die Ud there are provided radial slots 90

evenly arranged near distal end face 88 and passing onto its cylindrical

generatrix 84 (FIG. 13, 14), as weU as means for holding the free ends of

U-shaped staples and means for for separating from the stapler the

middles of these U-shaped staples 42 at the end of their working stroke.

AU these means are disposed in the body of die lid 22 near the points of

intersection of radial slots 90 with distal end face 88 and cylindrical

generatrix 84. Means for holding the free ends of U-shaped staples 42 are

shaped as torsion spring members 92 located near the points of

intersection of radial slots 90 with distal end face 88 and cyUndrical

generatrix 84 of die Ud 22 (FIG. 13, 14). Means for separating from the

stapler the middles of U-shaped staples 42 at the end of their working

stroke are shaped as recesses 94 (FIG. 14) disposed near the points of intersection of radial slots 90 with distal end face 88 and cyUndrical

generatrix 84 of this die Ud 22.

[0090] FIG. 15 shows in more detaU the pressure rod 34 operatively

connected via its distal end 40 with control lever 18, loaded by spring 44,

and having a thrust coUar 46 near its distal end 40. Pressure rod 34 (FIG.

2, 4) is adapted to reciprocate paraUel to its longitudinal axis 36 inside die

20 and die lid 22. Proximal end 38 of pressure rod 34 is substantiaUy

conical and located in the inner axial cavity 68 of die 20. Proximal end 38

of pressure rod 34 has an angle A at the cone vertex ranging from about

3 degrees to about 35 degrees, substantiaUy from 10 degrees to about 20

dregrees (FIG. 15).

[0091] FIG. 16 shows in more detaU a U-shaped staple 42. U-shaped

staple 42 has sUghtly bent and pointed ends 96 and is substantially

formed of a biocompatible metal.

[0092] Stapler 1 comprises curved L-shaped levers 48 (FIG. 17) serving

as a means for transmitting axial force from presure rod 34 to fastener

means, substantiaUy U-shaped staples 42, as weU as for converting this

axial foce into radial forces appUed to each of these U-shaped staples 42. The curved L-shaped levers 48 mounted via a hole at the end of its long

arm 98 on ring 50 (FIG. 18) and movably located in slots 100 of flange

102 of additional bush 52 (FIG. 19), between the free end of body 10 and

the end of this flange of additional bush 52 (FIG. 2) (according to the

first embodiment), or in slots 58 of inner ribs 56 of die 20 between the

free end of body 10 and the end of these inner ribs 56 (FIG. 4) (according

to the second embodiment). Levers 48 are movably disposed in slots 58

of inner ribs 56 of die 20. Curved L-shaped levers 48 are pivotally

mounted via the end of its long arm 98 on ring 50 evenly arranged in the

inner axial cavity of die 20 in such a manner, that their short arms 104

bent outwards relative to the longitudinal axis of the die are located in

corresponding through radial slots 72 in the bottom 70 of this die. Curved

L-shaped levers 48 are adapted to periodicaUy engage via inner sides 106

of its long arm 98 with conical proximal end 38 of pressure rod 34, and

via its free ends 108 of outwardly bent short arms 104 - with the middles

of corresponding U-shaped staples 42.

[0093] And at last, stapler 1 may comprise a die 20, die Ud 22 and

fastener means, substantiaUy U-shaped staples 42 located in grooves 78

of die 20, which form, in combination, a single set of the stapler actuator adapted to be detached from the body of this stapler 1 with foUowing

replacement by other, sirmlar interchangeable sets.

[0094] AU the aforesaid stapler embodiments are provided with a means

for temporal fixation outside, on the body of this stapler, of delivered

intravascular devices, substantiaUy grafts or stent-grafts (FIG. 2, 4). This

means is substantiaUy a lock screw 110 with a stop screw 112 located in

distal part 12 of hoUow body 10, aUgned with presure rod 34 and

disposed on the other side of the working end of control lever 18, as weU

as fastener means - U- shaped staples 42, with which lock screw 110 is

operatively connected via the working end of control lever 18 and

pressure rod 34.

[0095] AU the embodiments of the claimed tapler are provided with an

additional device which serves to prapare hyperfine and/or corrugated

intravascular devices for location and temporary fixation outside body 10

of this stapler (FIG. 21 - 24). This additional device contains a stepped

rod 120, thin-waU bush 130 and pressure bush 140. Stepped rod 120

(FIG. 21) has a first end 122 and second end 124 contains on its outer

surface several successively disposed cylindrical portions 126 forming,

in direction from the rod first end 122 to its second end 124, steps of increasing diameter. These cyUndrical portions 126 are linked together

via conical transition portions 128, the outer surface of the latter being

inclined at an acute angle in direction from first end 122 of the stepped

rod to its second end 124. The last step of the rod at its second end 124

has an outer diameter greater than the outer diameter of the next to last

step of this rod by a value exceeding four depths of waUs of said

intravascular device. Besides, the inclination angle C of the outer surface

of conical transition portion 128 between the next to last and last steps

disposed near the second end of this stepped rod is twice the incUnation

angles B of the outer surfaces of conical transUon portions between the

remaining steps of stepped rod 120.

[0096] The additional device further contains a thin-waU bush 130 (FIG.

22), the inner diameter whereof is greater than the outer diameter of the

next to last step of stepped rod 120 by a value exceeding two depths of

waUs of the intravascular device, and the outer diameter of this thin waU

bush 130 is smaUer than the outer diameter of the last step of rod 120 at

its second end by a value exceeding two depths of the walls of the

intravascular device. Thin-waU bush 130 is provied with a coUar 132 at

one its end (FIG. 22). [0097] At last, the ad nonal device contains a pressure bush 140 (FIG.

23) with thrust coUar 142 at one its end, the inner diameter whereof is

somewhat greater than the outer diameter of the last step of stepped rod

[0098] In addition to stapler 1, the claimed invention includes a method

for securing an intravascular device, such as graft or stent-graft 3, to the

waU of a blood vessel, sbstantiaUy the aorta 200 (FIG. 25, 26).

[0099] Let us consider, by way of example, the claimed method for

securing an intravascular device using the claimed stapler 1 to secure

graft 3. The method comprises several successive steps (FIG. 25). At the

first step a special stapler 1 is prepared for the operation. For this

purpose, there is checked the state of its loading with fastener means -

U-shaped staples 42 (if it is loaded or not), and if necessary, it is loaded.

Then there is fitted, over body 10 of this stapler 1, a corresponding

intravascular device, substantially graft or stent-graft, with partial

reversing, when necessary, one end of this intravascular device. To this

end, the additional device is used. The intravascular device - graft 3

being prepared is fitted over stepped rod 120 in such a way, that its free end is located on the last step of rod 120, beyond the transition portion

128. Thereupon a thin-waU bush 130 is fitted on the outside graft 3, bush

130 not being brought to the free end of graft 3 and located near the

conical transition portion 128. Then a pressure bush 140 is fitted over the

last step of rod 120 and moved towards the free end of graft 3 and thin-

waU bush 130. Therewith pressure bush 140 reverses the free end of graft

3 and passes outside the free end of graft 3 wrapped over thin-wall bush

130. If stepped rod 120 is removed thereafter from graft 3, the free end of

graft 3 remains wrapped over ftiin-waU bush 130 and clamped the latter

and' pressure bush 140. This aUows not only remove stepped rod 120

from graft 3, but also fit graft 3 instead of rod 120 over body 10 of stapler

1. If graft 3 has thin waUs, it may be more securely fixed on body 10 of

stapler 1 via its wrapped free end. The parameters of thin-waU bush 130

and pressure bush 140 are picked in such a way, that in wrapping the free

end of graft 3 formed as a corrugated tube, the projections of the part of

graft being wrapped enter the hoUows of its remaining part on removing

thin-waU bush 130. Graft 3 mounted on body 10 of stapler 1 is fixed

thereon via lock screw 110. By screwing in this lock screw 110 until stop

head 120 comes in contact with body 10, the working end of control lever 18 and pressure rod 34 are acted upon. Thereby U-shaped staples 42

sUghtly extend from die 20 and prick by their pointed ends graft 3 for

temporary fixing its position on body 10 of stapler 1. Stapler 1 is ready to

work.

[0100] At the next step there is created, by surgical means, a duct 202 for

access to the lumen of an operated blood vessel, substantially aorta 200,

directly through the waU of this blood vessel (aorta). Then, via thus

created duct 202, there is inserted into the lumen of an operated blood

vessel, substntiaUy the aorta 200, a special stapler 1 (FIG.l) with a

corresponding intravascular device, substantiaUy graft 3 fitted thereover,

and this graft 3 is located in a required place inside porta 200. Thereafter

stapler 1 is brought into operative position necessary for securing the first

end of the intravascular device, in this case graft 3, to the waU of a blood

vessel, substantiaUy aorta 200. Then the matching of mutual location of

the first end 204 of graft 3, the spot of its supposed securing to the wall

of aorta 200, as weU as the actuator of stapler 1 with fastener means - U-

shaped staples 42 located in die 20 at its free end. [0101] Then, in the actuator of stapler 1 there is created an axial force

sufficient to act on fastener means - U-shaped staples 42. Owing to this

force U-shaped staples 42, extending further from die 20 in radial

direction, punch not only the waU of the intravascular device - 3, but also

the surrounding wall of aorta 200 in such a manner, that the distal ends of

these U-shaped staples 42 partly project outsie aorta 200 and bend on its

outer surface, forming a rigid connection of first end 204 of graft 3 with

the waU of aorta 200. Then the actuator of stapler 1 is withdrawn from the

first end of the waU of aorta 200, whereby U-shaped staples 42 remain

fixed in the waU of graft 3 and in the waU of aorta 200, securing the first

end of graft 3 to a corresponding portion of aorta 200 and thus preventing

any its displacement relative to this aorta 200. Thereupon stapler 1 is

brought into inoperative position necessary for its free removal and

removed from graft 3 and from aorta 200.

[0102] At the next step in the intravascular device — graft 3 there is made

an incision 206 for access to its lumen. This is followed by introducing

through a duct created before and through an incision into the lumen of

graft 3 a second special stapler 1 for securing second end 208 of this

graft 3 to the waU of aorta 200. This stapler 1 is brought into operative position, whereupon its actuator with U-shaped staples 42 located in die

20 at its free end is brought to the waU of graft 3, at the spot of securing

its second end to the waU of aorta 200. Then the matching of mutual

location of second end 208 of graft 3, spot of its supposed securing to the

waU of aorta 200, as weU the actuator of second stapler 1 with U- shaped

staples 42. On creating in the actuator of this second stapler 1 an axial

force sufficient to act on U-shaped staples 42, the latter, extending from

die 20 in radial direction, punch not only the wall of graft 3 and

surrounding waU of aorta 200 in such a way, that distal ends of these U-

shaped staples 42 partly project outside aorta 200 and bend on its outer

surface, forming a rigid connection of second end 208 of graft 3 with the

waU of aorta 200. Then the actuator of second staoler 1 is withdrawn

from the waU of graft 3, whereby U-shaped staples 42 remain fixed in the

wall of graft 3 and in the waU of aorta 200, securing second end 208 of

graft 3 with a corresponding portion of aorta 200 and thus preventing any

its displacement relative to this aorta 200. Then stapler 1 is brought into

inoperative position, necessary for its free removal from graft 3 and

removed therefrom and from aorta 200.

[0103] At the last step, there are closed by surgical means incision 206 n

graft 3 and duct 202 for access to the lumen of graft 3 and to the lumen of operated aorta 200. Owing to the above manipulations, there is formed a

secure multiple-point connection of graft 3 with the wall of aorta 200

preventing displacement of this graft 3 from a given position due to blood

flow and peristelsic oscUlations of the waUs of aorta 200.

[0104] According to the clamed method, it is also possible to secure the

ends of another intravascular device, such as stent-graft 220 (FIG. 22)

having a broad proximal part 222 and bifurcated distal part 224 and 226,

to the waU of aorta 200. This is performed by a set of at least two staplers

1 and using in each of them simultaneously at least two fastener means -

U-shaped staples 42. The set contains at least one first stapler for securing

broad proximal part 222 of stent-graft 220 to the waU of aorta 200 and at

least one second stapler for securing to the waU of aorta 200 the

bifurcated istal part 224 and 226 of stent-graft 220. Securing the end of

stent-graft having a broad proximal part 222 to the wall of aorta 200 in

the neck area 228 of aorta 200 is performed by the first of staplers 1

comprised in the set of staplers and using at least two U-shaped staples

42. [0105] The distal end of stent-graft 220 having a bifurcated distal part

224 and 226 is secured to the waU of aorta 200 via the second of staplers

comprised in the set, and using simultaneously at least two U-shaped

staples 42. It is secured near the free end of one 224 or another 226 of the

branches of the bifurcated distal part of this stent-graft 220.

[0106] And at last, according to the claimed method, stent-graft 220

may be secured to the waU of aorta 200 using at least two U-shaped

staples 42, near the free end of both branches 224 and 226 of the

bifurcated distal part of stent-graft 220.

[0107] The appUcation of the claimed new and improved method for

fixing in combination with the new stapling device - stapler 1 operating

on the basis of this method aUows to solve the problem of providing

secure and relatively simple means for securing intravascular devices to

the waUs of blood vessels. SpecificaUy, their application aUows to solve

the problem of securing stent-graft 220 to the wall of aorta 200 or the

problem of securing grafts and other simUar devices to the waUs of blood

vessels unless these devices possess adequate inherent fixation to prevent

their displacement from given positions. [0108] WhUe this invention has been described in conjunction with

specific embodiment thereof, it is evident that many alternatives,,

modifications and variations wUl be apparent to -those skilled in the art.

Accordingly, the preferred embodiments of the invention as set forth

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

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

defined in the foUowing claims.

Claims

C L A I M S

1. A method for mfraluminal fixation of intravascular devices,

substantially grafts or stent-grafts, comprising the foUowing

successive steps:

a) praparing a special stapler for operation by checking the state of its

loading with fastener means and following fitting on. the body of this

stapler a corresponding intravascular device, substantiaUy graft or

stent-graft, with partial reversing, in necessary, one end of this

intravascular device, as well as securing the latter to the stapler body

by a means for its temporary fixation;

b) creating by surgical means a duct for access to the lumen of an

operated blood vessel, substantiaUy the aorta, directly through the waU

of this blood vessel ;

c) inserting through said duct into the lumen of an operated blood

vessel substantiaUy the aorta, a special stapler with a corresponding

intravascular device, substantiaUy a graft or stent-graft mounted an

fixed thereon, and placing this intravascular device in a desired

position; d) bringing the stapler into operative position for securing the first end

of this intravascular device to the waU of this blood vessel,

substantiaUy aorta;

e) checking the matching of mutual location of the first end of the

intravascular device, the place of its supposed securing to the waU of a

blood vessel, as weU as the actuator of said stapler with fastener means

located near its free end;

f) creating in said stapler actuator radial forces sufficient to act on said

fastener means, whereby these fastener means, extending from the

actuator in radial direction, punch the wall of said intravascular device

and the surrounding waU of the blood vessel in such a way, that the

distal ends of these fastener means partly pass out°ide the blood vessel

and bend on its outer surface to form a rigid connection of the first end

of the intravascular device with the wall of the blood vessel;

g) withdrawing said actuator from the first end of the waU of said

intravascular device, whereby said fastener means remain fixed in the

waU of said intravascular device and in the waU of the blood vessel,

securing the first end of the intravascular device to a cortresponding

portion of the blood vessel and thus preventing any its displacement

relative to this blood vessel; h) bringing the stapler into inoperative position necessary for its free

removal from said intravascular device and from said blood vessel;

j) removing the stapler from the blood vessel;

1) making an incision in said intravascular device for access to its

lumen;

m) inserting through said duct and through said incision into the lumen

of the intravascular device, substantiaUy graft or stent-graft,

another special stapler for securing the second end of this

intravasular device to the waU of this blood vessel, substantially the

aorta;

n) bringing another speial stapler into operative position to secure the

second end of this intravascular device to the wall of this blood

vessel;

o) bringing to the waU of the intravascular device, at the place of

securing its second end to the blood vessel waU, the actuator of said

another stapler; p) checking the matching of mutual location of the second end of

said intravascular device, the place of its supposed securing to the

aU of the blood vessel, as well as the actuator of said another

stapler with fastener means located near its free end;

q) creating in said actuator of this stapler radial forces sufficient for

acting on said fastener means, whereby these fastener means,

extending from th actuator in radial direction, punch the waU of

saaid intravascular device and the surrounding blood vessel wall in

such a way that the distal ends of these fastener means partly project

outside the blood vessel and bend on its outer surface to form a rigid

^' connection of the second end of said intravascular device with the

blood vessel waU;

r) withdrawing said actuator of another stapler from the waU of the

intravascular device, whereby said fastener means remain fixed in

the waU of said intravascular device and in the blood vessel waU to

secure the second end of said intravascular device with a

corresponding blood vessel portion and thus prevent any its

displacement relative to this blood vessel;

s) bringing another stapler into inoperative position necessary for its

free removal from said intravascular device and from said blood

vessel; t) removing the stapler from the blood vessel;

u) closing by surgical means said incision in the intravascular device

and said duct for access to the lumen of the intravascular device

and into the lumen of the operate blood vessel,

whereby there are formed secure multiple-point connections of the ends

of said intravascular device with the blood vessel wall to prevent the

displacement of this intravascular device from a given position due to

blood flow and peristelsic osciUations of the walls of this blood vessel.

2. A method according to claim 1, wherein the ends of said intravascular

device, substantiaUy graft or stent-graft, are secured to the waU of a blood

vessel via at least one said stapler and using at least two said fastener

means simultaneously at least at two points, substantiaUy near one of the

free ends of this intravascular device.

3. A method according to claim 1, wherein the ends of said intravascular

device, substantiaUy graft, are secured to the wall of a blood vessel by a

set of at least two said staplers and using in each of these staplers at lest two said fastener means secured simultaneously at least at two points,

substantiaUy near each of the free ends of this intravascular device.

4. A method according to claim 1, wherein the ends of said intravascular

device, substantiaUy stent-graft, having a broad proximal part and

bifurcated distal part, are secured to the waU of a blood vessel,

substantiaUy the aorta, by a set of at least two said staplers and using in

each of them at least two said fastener means.

5. A method according to claim 4, wherein the ends of said intravascular

device, substantiaUy stent-graft, having a broad proximal part and

bifurcated distal part are secured to the wall of a blood vessel,

substantiaUy aorta, by a set of at least two said staplers and using in each

of them simultaneously at leas two said fastener means, the set including

at least one first stapler for securing the broad proximal part of stent-graft

to the aorta wall and at least one second stapler for securing the

bifurcated distal part of stent-graft to said aorta waU.

6. A method according to claim 5, wherein the proximal end of said

intravascular device, substantially stent-graft, having a broad proximal

part and bifurcated distal part, is secured to the waU of a blood vessel,

substantiaUy aorta, in the neck area of this aorta, by the first of said

staplers comprised in said set of staplers, and using simultaneously at

least two said fastener means.

7. A method according to claim 5, wherein the distal end of said

intravascular device, substantially stent-graft, having a broad proximal

part and bifurcated distal part is secured to the wall of a blood vessel,

substantiaUy aorta, by the second of said staplers and using at least two

said fastener means, near the free end of one of the branches of said

bifurcated distal part of this stent-graft.

8. A method according to claim 5, wherein the distal end of said

intravascular device, substantiaUy stent-graft, having a broad proximal

part and bifurcated distal part is secured to the waU of a blood vessel,

substantiaUy aorta, by the second of said staplers and using

simultaneously at least two said fastener means, near the free end of the

second branch of the bifurcated distal part of this stent-graft.

9. A method according to claim 5, wherein the distal end of said

intravascular device, substantially stent-graft, having a broad proximal

part and bifurcated distal part is secured to the wall of a blood vessel,

substantiaUy aorta, by means of the second of said staplers and using

simultaneously at least two said fastener means, near the free ends of both

branches of the bifurcated distal part of this stent-graft.

10. A stapler for mfraluminal fixation of intravascular devices,

substantiaUy grafts or stent-grafts, comprising:

i) a substantiaUy cylindrical hoUow body having an inner axial

cavity, proximal end and distal end with a holding handle

extending therefrom a side at a certain angle, and control lever

pivotaUy mounted on this holding handle, and at the proximal end

of the hoUow body there is rigidly secured an actuator containing a

die and a die Ud aUgned with said hoUow body and in succession

in direction to the free end of the stapler;

U) a die for locating fastener means, substantiaUy U-shaped staples,

shaped substantiaUy as a barrel having a proximal end, distal end,

substantiaUy cyUndrical generatrix and an inner axial cavity open

on the side of said barrel distal end and terminating in a bottom at said proximal end of the barrel, this bottom having a through axial

hole, through evenly arranged radial slots, and on its end face

presented to the die Ud - recesses with grooves for locating fastener

means, substantiaUy U-shaped staples, these recesses with grooves

are aUgned with said radial slots and provided with means for

setting apart the ends of said U-shaped staples, these means are

arranged along the axes of grooves, right up to the cyUndrical

generatrix of said die and are substantiaUy V-shaped;

i) a die Ud having a through axial hole, substantiaUy cyUndrical

generatrix, proximal and distal end faces, radial slots', evenly

arranged in the body of the die Ud near its distal end face passing

onto its cyUndrical generatrix, as weU as means for holding the free

ends of U- shaped staples and means for separating from the stapler

the middles of these U-shaped staples at the end of their working

stroke, these means being located near the points of intersection of

said radial slots with said distal end face and said cyUndrical

generatrix of this die Ud;

iv) a pressure rod dispose inside said hoUow body, having a

longitudinl axis, proximal end and distal end, this pressure rod

being operatively connected via its distal end with said control lever, and its proximal end is substantiaUy conical and reciprocably

located in the inner axial cavity of the die;

v) means for transmitting axial force from said pressure rod to sad

fastener means, substantiaUy U-shaped staples, and for converting

this axial force into radial forces appUed to each of these U-shaped

staples located substantiaUy in said inner axial cavity of the die to

periodicaUy engage the proximal end of said pressure rod;

vi) a means for temporary fixation on the stapler body of deUvered

intravascular devices, substantiaUy grafts or stent-grafts located

outside on the stapler body,

whereby said intravascular device is deUvered to the required area of a

blood vessel and is fixed on the waU inside this blood vessel, the free

ends of fastener means, substantiaUy U-shaped staples, punching the waU

of said intravascular device and the surrounding wall of the blood vessel

partly project outside the corresponding blood vessel, to form a rigid

connection of the intravascular device with the wU of this blood vessel.

11. A stapler according to claim 10, wherein said substantiaUy cyUndrical

hoUow body has a proximal end and a distal end with a holding handle

extending aside therefrom at a certain angle, from about 30 degrees to

about 90 degrees, and a control lever pivotaUy mounted on this holding

handle.

12. A stapler according to claim 10, wherein said die for locating fastener

means is shaped a a barrel with a substantially cylindrical generatrix and

inner axial cavity open on the side of the distal end of the barrel and

terminating in a bottom at the proximal end of the barrel, the die having

through evenly arranged radial slots on its bottom, and on the end face of

this bottom presented to said die Ud - recesses with grooves for locating

fastener means, substantiaUy U-shaped staples, and with means for

setting apart the ends of the latter, these recesses with grooves having

substantiaUy the same depth relative to said end face of the die bottom

and and being aligned with said radial slots.

13. A stapler according to claim 10, wherein said die for locating

fastener means, substantiaUy U-shaped staples, is shaped as a barrel with

a substantiaUy cyUndrical generatrix and inner axial cavity open on the side of the barrel distal end and terminating in a bottom at the proximal

end of said barrel, the die having through evenly disposed radial slots on

its bottom, and on the end face of this bottom presented to said die lid -

recesses with grooves for locating fastener means, and with means for

setting apart the latter, these recesses with grooves having substantially

different depths relative to said end face of the die bottom and being

aUgned with the radial slots.

14. A stapler according to claim 13, wherein said recesses with grooves

have at least two different depths relative to said end face of the die

bottom, these recesses with grooves of different depth", alternating.

15. A stapler according to claim 10, wherein said fastener means are

substantiaUy U-shaped staples and located radiaUy in said grooves of

said stapler die to be extended radially from these grooves due to radial

forces, the free ends of said U-shaped staples being located on either side

of said means for setting apart the ends of these fastener means, arranged

along the axes of said grooves, right up to the cyUndrical generatrix of

said die and being substantiaUy V-shaped.

16. A stapler according to claim 15, wherein said means for setting apart

the ends of said fastener means, substantiaUy U-shaped staples, are

located along the axes of grooves, right up to the cyUndrical generatrix of

said die and substantially V-shaped, with guiding sides which are

substantiaUy curved, concave and diverging from one another in direction

from the center of said die to its cyUndrical generatrix wich aUows to

bend outwards the free ends of fatener means when they are extended

from the die due to said radial forces.

17. A stapler according to claim 15, wherein said means for setting apart

the ends of said fastener means, substantiaUy U- haped staples, are

arranged along the axes of grooves, right up to the cyUndrical generatrix

of said die and are substantiaUy V-shaped, with guiding sides which are

substantiaUy radial, concave and diverging from one another in direction

from the center of said die to its cyUndrical generatrix, which aUows to

bend outwards the free ends of fastener means when they are extended

from the die due to said radial forces.

18. A stapler according to claim 10, wherein said die Ud is provided with

means for holding the free ends of said fastener means, substantiaUy U-

shaped staples, containing torsion spring members located near the points

of intersection of said radial slots with said distal end face and said

cyindrical generatrix of this die Ud.

19. A stapler acording to claim 10, wherein said die Ud is provided with

means for separating from the stapler the middles of said fastener means,

substantially U-shaped staples, at the end of their working stroke, these

means containing recesses located near the points of intersection of said

radial slots with said distal end face and said cylindrical generatrix of this

die Ud.

20. A stapler according to claim 10, wherein said die Ud is made of a

transparent material for checking the state of fastener means, substantiaUy

U-shaped staples.

21. A stapler according to claim 10, wherein said pressure rod has a

longitudinal axis, substantiaUy conical proximal end, distal end and thrust

coUar near its distal end, this pressure rod being spring-loaded,

operatively connected via its distal end with said control lever and

reciprocable inside said hoUow body, and by its substantiaUy conical

proximal end - inside said inner axial cavity of the die.

22. A stapler according to claim 21, wherein said pressure rod has a

substantiaUy conical proximal end with an angle at the cone vertex

ranging from about 3 degrees to about 35 degrees.

23. A stapler according to claim 22, wherein said presure rod has a

substantiaUy conical proximal end with an angle at the cone vertex

substantially from 10 degrees to ubstantially 20 degrees.

24. A stapler according to claim 1, wherein said means for transmitting

axial force from said pressure rod to said fastener means, substantiaUy U-

shaped staples, and for converting this axial force into radial forces

appUed to each of these U-shaped staples are curved L-shaped levers pivotaU mounted via the end of its long arm near the free end of said

hoUow body and evenly arranged inside said inner axial cavity of the die

in such a way, that their short arms bent outwards relative to the

longitudinal axis of the die are disposed in corresponding through radial

slots on the bottom of this die, said curved L-shaped levers being adapted

to periodicaUy engage via the inner sides of its long arm said substantially

conical proximal end of the pressure rod, and via its free ends of short

arms bent ouwards - the middles of corresponding U-shaped staples.

25. A stapler according to claim 24, whwrein said curved L-shaped levers

are pivotally mounted via the ends of their long arms on a ring located

inside said inner axial cavity of the die, in the clearance between the free

end of said hoUow body and flange of an additional bush rigidly secured

substantiaUy inside this hollow body, said flange having evenly arranged

radial slots, in each whereof there is movably disposed a corresponding

curved L-shaped lever.

26. A stapler according to claim 24, wherein said curved L-shaped levers

are pivotaUy mounted via the ends of their long arms on a ring disposed

inside said inner axial cavity of the die, in the clearance between the free end of said hoUow body and inner ribs of this die extending from the waU

of its inner axial cavity towards the longitudinal axis of this die, said ribs

having evenly disposed radial slots in each whereof there is movably

located a corresponding curved L-shaped lever.

27. A stapler according to claim 1, wherein said die, die lid and fastener

means, subtantially U-shaped staples located in die grooves form, in

combination, a single set of the stapler actuator which is capable of being

detached from the body of said stapler with foUowing replacement by

other, simUar interchangeable sets.

28. A stapler according to claim 10, wherein said means for temporary

fixation on the stapler body intravascular devices substantiaUy grafts or

stent-grafts, disposed on this stapler body outside, contains substantiaUy a

lock screw with a stop head located in body distal part, in aUgnment wih

aid pressure rod and on the other side of the working end of said control

lever, as weU as fastener means, substantiaUy U-shaped staples, where

with said lock screw is operatively connected via the working end of said

control lever and said pressure rod.

29. An additional device for a stapler for mfraluminal fixation of

intravascular devices, substantiaUy grafts or stent-grafts, which serves to

prepare hyperfine and/or corrugated intravascular devices for location and

temporary fixation outside the body of this stapler, this additional device

containing:

- a stepped rod having a first end and a second end and and provided

on it outer surface several successive cylindrical portions forming,

in direction from the first end of said rod to its second end, steps

of increasind diameters, these cylindrical portions being joined

together via conical transition portions, and the last step of the rod

at its second end has an outer diameter greater than the outer

diameter of the next to last step of the rod by a value exceeding

four thicknesses of the waUs of said intravascular device;

- a thin-waU bush the inner diameter whereof is greater than the

outer diameter of the next to last step of said rod by a value

exceeding two thicknesses of the waUs of aid intravascular device,

and the outer diameter of this thin-waU bush is smaUer than the

outer diameter of the last step of said rod at its second end by a

value exceeding two thicknesses of the waUs of said intravascular device, the thin-waU bush being provided with a thrust collar at

one its end;

- a pressure bush with a thrust coUar at one its end the inner

diameter whereof is somewhat greater than the outer diameter of

the last step of said rod at its second end.

30. An additional device according to claim 29, wherein said stepped rod

has a first end and a second end, several successive cyUndrical portions

forming in direction from the first end of said rod to its second end steps

of increasing diameter, and these cyUndrical steps are joined together via

conical transition portions the outer surface whereof is inclined at an

acute angle in direction from the first end of said stepped rod to its second

end.

31. An additional device according to claim 30, wherein the inclination

angle of the outer surface of said conical transition portion between the

next to last and last steps disposed near said second end of said stepped

rod is twice the incUnation angles of outer surfaces of conical transition

portions between the remaining steps of said stepped rod.