Patent Application
20090132021
This application is related to Patent Cooperation Treaty (“PCT”) patent applications PCT/IL2005/000115, filed Feb. 1, 2005, PCT/IL2005/000188, fled Feb. 15, 2005 and PCT/IL2005/001217, filed Nov. 17, 2005, as well as continuation-in-part Israel patent applications IL 166648, filed Feb. 1, 2005, IL 168993, filed Jun. 2, 2005, IL 169210, filed Jun. 16, 2005 and IL 170003, Filed Aug. 1, 2005.
All our earlier patent applications relate to medicine, in particular, to vascular surgery. In all our earlier patent applications, other than IL 166648, filed Feb. 1, 2005, IL 168993, filed Jun. 2, 2005 IL 169210, filed Jun. 16, 2005 and IL 170003, Filed August 1, there are described apparatus and methods for delivery of vascular grafts or stent-grafts inside a blood vessel, substantially the aorta, and for their suturing by one end, which allows to accomplish surgical treatment of such diseases as aorta aneurysm. These methods and apparatus allow to prevent rupture of an aorta aneurysm by locating and suturing inside this aorta a synthetic prosthesis—graft or stent-graft. In patent applications IL 166648, filed Feb. 1, 2005, IL 168993, filed Jun. 2, 2005 and IL 170003, Filed August 1, there are described an apparatus and method for grafts or stent-grafts delivery inside the aorta and their alternate suturing by both ends. All these apparatus and methods have been developed on the basis of prior art and background described in detail in our above mentioned PCT and Israel patent applications.
At the same time, in performing surgical operations for preventing aorta rupture, in particular, of the abdominal aorta section, as well as in performing surgical operations for cleaning blood vessels from calcium patches and other thrombotic deposits using apparatus of “Rotablater” type, it would be appropriate to apply thin-wall or superthin-wall grafts—about 0.1 mm or even less, which might be spread, in particular, over cleaned inner surfaces of blood vessels to prevent formation of new thrombi and deposits. This raises the question of delivering the thin-wall graft inside a blood vessel and successively performing the steps necessary for suturing this graft by one end, its stretching or spreading along the blood vessel lumen, as well as suturing the graft by its second end.
An object of the present invention is to develop a new method and apparatus providing delivery and double-ended fixation of implanted endovascular prosthesis—grafts or stent-grafts, in corresponding blood vessels.
Another object of the present invention is to develop a system of apparatus assembled from a kit of standardized parts (similar to a construction kit for children) which allows to assemble fast an apparatus adapted to the anthropometric conditions of a specific patient and intended for performing a surgical operation to deliver a graft or stent-graft of a specific type and size and double-ended fixation of the latter to the a blood vessel wall.
A third object of the present invention is to develop a new method of endovascular thin wall grafts spreading and double-ended fixation to blood vessel walls.
The subject-matters of the present invention are an apparatus and method for delivery and double-ended fixation of endovascular grafts or stent-grafts to blood vessel walls. The proposed apparatus comprises a tubular body, two expandable working heads with cartridges intended for location of fastener means, with means for securing the ends of an endovascular graft or stent-graft on these heads, as well as a control mechanism containing two control modules joined together via a connecting means.
The apparatus tubular body is configured for positioning within a vessel. This tubular body is rigid in longitudinal direction and flexible in lateral direction, at one its end there are located two working heads, and at its second end—the control mechanism.
The apparatus has two expandable working heads, each with cartridges intended for location of fastener means. These working heads are located at the free end of tubular body and made expandable to keep both ends of a delivered graft or stent-graft in contact with the blood vessel inner surface at the moment of their mutual fixation.
Each of the two working heads contains a cartridge group including substantially eight cartridges which are incorporated in the construction of a corresponding working head. All the cartridges are unified and interchangeable, and each of these cartridges is intended for location at least of two fastener means. All the cartridges are provided with means for retaining therein fastener means, for imparting thereto progressive motion, for forming fastener means during their extension from these cartridges, as well as for storing and feeding standby fastener means. Both working heads are also provided with means for securing thereon the ends of an endovascular graft.
Control mechanism of the proposed apparatus is provided with a first control module and second control module joined together via a connecting means. The control mechanism is located at the tubular body end opposite to the working heads and associated with these working heads via the tubular body. The first control module is located at the free end of this tubular body, and the second control module is located on the tubular body near the first module, between the latter and the second expandable working head. The first control module serves for operation of first working head, and second control module serves for operation of second working head. Control modules are joined together via a connecting means located between them on the tubular body.
The proposed apparatus have two embodiments. In the first embodiment this apparatus may be used for delivery and double-ended fixation of endovascular grafts or stent-grafts. The control mechanism of the apparatus have a rigid fixation of modules relative to one another.
In the second embodiment the apparatus may be used for delivery, spreading and double-ended fixation of thin wall endovascular grafts. For this purpose the second working head, which is secured near the free end of tubular body, some distance away from the first working head, aligned with the latter and capable of reciprocation relative thereto, and a connecting means, located on the tubular body between the first and second control modules capable of providing reciprocation of second control module and second working head rigidly attached thereto relative to the first control module. As a result, a surgical operation may be performed for thin wall graft delivery, spreading within the blood vessel and fixing both its ends to the walls of a blood vessel wall, substantially the aorta, from inside the aorta.
The first expandable working head contains a first pressure bush, first and second bearing bushes, arranged in succession one after another beginning from the free end of this working head and in alignment with the tubular body, as well as a first axial tube rigidly connected with the first bearing bush and passing via a through axial hole in second bearing bush.
First expandable working head is provided with eight cartridges which are pivotally secured by one their ends on first bearing bush and pivotally connected by their other ends with bearing levers pivotally mounted on second bearing bush.
Second expandable working head located some distance away from first working head contains a third and fourth bearing bushes and second pressure bush which are arranged successively one after another beginning from the free end of this working head facing the first expandable working head. Second head also has a second axial tube rigidly connected with third bearing bush and passing via through axial holes in fourth bearing bush and in second pressure bush. Third and fourth bearing bushes and second pressure bush are aligned with tubular body. Second working head is also provided with eight cartridges secured by one their ends on fourth bearing bush and pivotally connected by their other ends with bearing levers which are pivotally mounted on third bearing bush.
First and second working heads are provided with means for securing a delivered graft or stent-graft located on bearing levers and shaped substantially as radial tongues located at one of the ends of these bearing levers, near their pivotal connections with corresponding cartridges.
Each of the cartridges contains a means for retaining therein at least one basic fastener means, substantially U-shaped staple. This means for retaining is located along the cartridge and contains substantially a sliding lid.
Each of the apparatus cartridges includes at least one means for imparting progressive motion to the fastener means, substantially U-shaped staple, and this means contains a flexible pusher, rigid in longitudinal direction and flexible in lateral direction. All flexible pushers are associated by one their end with first or second pressure bush of first or second expandable working head respectively and located under the sliding lid to reciprocate in the clearance between the cartridge bottom and this sliding lid.
Each of the apparatus cartridges contains a means for forming fastener means located in this cartridge near one of its ends, as well as at least one basic fastener means, substantially U-shaped staple, located in this cartridge substantially along its longitudinal axis, with free pointed ends facing this means for forming. The U-shaped staple is located in the cartridge so as to progressively extend therefrom and be formed during this extension.
Each cartridge has a bottom and sliding lid and contains a means for storing at least one standby fastener means, substantially standby U-shaped staple. This means for storing contains a slot in cartridge bottom wherein at least one spring-loaded standby U-shaped staple is located. The standby staple is located in this slot substantially along the longitudinal cartridge axis, with free pointed ends facing the means for forming. This standby U-shaped staple is located in the slot of this cartridge bottom substantially under the flexible pusher so as to extend from this slot by action of spring and at partial removal of this flexible pusher from the clearance between the cartridge bottom and sliding lid. In the most preferred embodiment the slot in each cartridge bottom is a through one, and the standby U-shaped staple is, located in this slot immediately under the flexible pusher and spring-loaded on the opposite side.
Each of the apparatus cartridges has a body with a bottom provided with a recess for location at least of one basic fastener means, substantially U-shaped staple, and a through slot for location at least of one standby fastener means, substantially standby spring-loaded U-shaped staple, slots for mounting the sliding lid, as well as with a longitudinal duct for location at least of one flexible pusher. Therewith, the basic U-shaped staple is located in bottom recess of cartridge body in frictional contact with the sliding lid, which prevents its dropping out of this recess, and standby U-shaped staple is located in the through bottom slot of cartridge body in frictional contact with the flexible pusher, which prevents its extension from this through slot before partial removal of this flexible pusher.
The body bottom of each cartridge has a recess at least for one basic fastener means, substantially U-shaped staple. This recess is symmetric about the longitudinal axis of this cartridge and parallel with its outer surface. The cartridge is provided with a means for forming U-shaped staple during its extension from the recess, and this means contains a curvilinear guiding surface connecting the bottom of this recess for U-shaped staple with the cartridge outer surface. The curvilinear guiding surface has forming grooves diverging at an acute angle from one another and from the cartridge longitudinal axis. The basic fastener means, substantially U-shaped staple, has pointed free ends and is located in body recess of this cartridge in such a way, that its pointed ends face corresponding forming grooves on curvilinear guiding surface.
Forming grooves diverging at an acute angle from one another 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 curvilinear guiding surface of this cartridge.
Each apparatus cartridge is 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 lies on the longitudinal axis of expandable working head. All cartridges are provided with means for connection respectively with first or fourth bearing bush of first or second working head or with a corresponding bearing lever. These means contain arms with holes which project from both bases of the polyhedral prism and are integral with this polyhedral prism.
All U-shaped staples are made from one of the materials of a group including stainless steel, titanium and shape memory alloys.
The apparatus is additionally provided with a means for axial precision positioning containing a measuring scale on the tubular body surface, as well as with means for radial precision positioning containing markers—X-ray marks evenly applied on the upper surface of cartridges and serving for orientation of the apparatus working heads by their operation angle.
The control mechanism has a first and a second control modules joined together via a connecting means. First control module is located at the free end of tubular body opposite to first expandable working head, and second control module is rigidly connected with second expandable working head and located on tubular body near first control module, between the latter and second expandable working head. The connecting means located on tubular body between first and second control modules may provide either their rigid mutual fixation, or reciprocation of second control module and second working head rigidly attached thereto relative to first control module. This connecting means substantially contains a holder with a gear pivotally mounted therein and provided with a lock and rotary drive, as well as two toothed racks operably engaged with the gear, the first of the racks being rigidly connected with first control module, and the second rigidly connected with second control module. The connecting means is additionally provided with a handle and support for carrying the apparatus and its location on the operating table. It is also provided with the gear rotary drive which is substantially mechanic or electric.
First control module of control mechanism contains a hollow body having a first and second ends, as well as a slider enclosed in this body to reciprocate relative to the latter. The slider is provided with a holding handle rigidly attached thereto and functionally associated with the pivotal head located at the second end of this hollow body. This slider together with the pivotal head forms the first control means of first control module of the control mechanism.
First control module of the control mechanism further contains a first pressure handle serving as a second control means. This first pressure handle is pivotally attached to holding handle and has a short free end enclosed in the slider. The slider is rigidly connected with first axial tube serving as a first connecting means, and the short free end of pressure handle is functionally associated with a tie serving as a second connecting means of first control module of the control mechanism. First pressure handle is provided with a swing lock pivotally mounted on the slider, as well as with a flat return spring secured by one its end to this pressure handle, and by its second end—to the holding handle.
In the proposed apparatus first bearing bush of the first expandable working head is functionally connected via first connecting means with first control means of the first control module. First pressure bush is functionally connected via second connecting means with second control means of first control module of the control mechanism. Second bearing bush is rigidly connected with a distance tube located between first and second working heads. First connecting means and second connecting means are enclosed in the distance tube and tubular body concentrically with one another, with the distance tube and this tubular body.
Second control module of the control mechanism contains a hollow body with a handle rigidly attached thereto or integral therewith. This body has a first and second end, is rigidly connected by its first end via a retaining tube with fourth bearing bush of second working head and also includes a slider enclosed in the body to reciprocate relative to the latter. The slider is functionally associated with the pivotal head located at the second end of this hollow body and forms together with this pivotal head a first control means of second control module of the control mechanism.
The second control module also has a second pressure handle serving as its second control means and pivotally secured to the handle or hollow body. This second pressure handle has a short free end enclosed in the slider, and the latter is rigidly connected with a tubular tie serving as a third connecting means, and the short free end of pressure handle is functionally associated with a pressure tube serving as a fourth connecting means of the control mechanism and rigidly connected with the second pressure bush. Second pressure handle is provided with a swing lock pivotally mounted in the hollow body, as well as with a flat return spring secured by one its end to this second pressure handle, and by its other end to the hollow body handle.
Third bearing bush is connected via third connecting means with first control means of second control module of the control mechanism. Second pressure bush is functionally connected via fourth connecting means with second control means of second control module of the control mechanism, and fourth bearing bush is connected with the body of second control module via retaining tube. Third connecting means of second module is enclosed in the retaining tube, and this fourth connecting means of second module is located outside this retaining tube, and they are all arranged concentrically with one another and this retaining tube.
First and second connecting means connect first expandable working head with first control module of the control mechanism. They are arranged concentrically with one another within third connecting means, retaining tube and fourth connecting means which are also arranged concentrically with one another and link second working head with second control module of the control mechanism. The distance tube is located between first and second working heads outside the first and second connecting means and in alignment with third and fourth connecting means. The fourth connecting means located outside, concentrically with retaining tube, third connecting means, as well as with first and second connecting means, forms a tubular body configured for positioning within a vessel. This tubular body, together with connecting means enclosed therein, is rigid in longitudinal direction and flexible in lateral direction.
Another subject-matter of the present invention is a method for delivery and double-ended fixation of grafts or stent-grafts to the wall of a blood vessel from within the latter, comprising several successive steps.
At the first step, the graft or stent-graft is prepared for delivery, mounted and its both ends secured on the apparatus working heads. The graft or stent-graft is located between the working heads and crimped to a given outer diameter.
At the second stage, the apparatus for delivery and fixation is brought in operative position, inserted into a corresponding blood vessel, first expandable working head is brought to the securing area, and precision axial and radial positioning of the apparatus at a given blood vessel point is performed via a measuring scale on tubular body surface and via markers—X-ray contrast marks. Then first working head is deployed in such a way, that the first end of a delivered graft or stent-graft is in contact with the inner surface of this blood vessel at the moment of their mutual fixation, and the cartridges of this expandable working head are located near corresponding suturing points.
Thereupon U-shaped staples in the cartridges of first expandable working head are set in motion, which is accomplished by action of flexible pushers activated, in their turn, via first pressure bush, second connecting means and second control means of first module of the control mechanism, which is associated with these pushers. As a result, pointed ends of each of the U-shaped staples enter the forming grooves of curvilinear guiding surface of a corresponding removable cartridge, are curled therein, diverging in opposite directions from one another, pierce the prosthesis wall and surrounding blood vessel wall and return again over a spiral to the curvilinear guiding surface, repeating this rotation if permitted by the given staple length. As a result, the wall of this prosthesis first end gets sutured by wire spirals formed from U-shaped staples to a corresponding area of the blood vessel wall, and the U-shaped staples themselves entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming an oversew suture at the first end of a corresponding prosthesis.
Then the cartridges of first expandable working head are reloaded with standby U-shaped staples. This is accomplished by partial removal of flexible pushers activated, in their turn, via first pressure bush, second connecting means and second control means of first module of the control mechanism, which are associated with these pushers. As a result, each of the spring-loaded standby U-shaped staples emerges from the through slot of a corresponding cartridge, and then, at reverse motion of a corresponding flexible pusher, moves by its action into a recess wherein the basic U-shaped staple was located before. Now the first head of the apparatus for delivery and fixation is ready for another suturing.
Then, if another suturing is necessary, U-shaped staples in the cartridges of first expandable working head are set in motion. This is accomplished by action of flexible pushers activated, in their turn, via first pressure bush, second connecting means and second control means of first module of the control mechanism, which are associated with these pushers. As a result, pointed ends of each of the standby U-shaped staples enter the forming grooves of curvilinear guiding surface of a corresponding removable cartridge, are curled therein, diverging in opposite directions from one another, pierce the wall of the prosthesis first end and surrounding blood vessel wall and return again over a spiral to the curvilinear guiding surface, repeating this rotation if permitted by the given staple length. As a result, the wall of this prosthesis first end gets sutured again by wire spirals formed from standby U-shaped staples to a corresponding area of the blood vessel wall, and the standby U-shaped staples themselves entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming a second oversew suture at the first prosthesis end.
Then, if it is necessary, the prosthesis—a thin wall graft, sutured at one end, is spread. This is accomplished by rotation of the connecting means gear, which enables the second control module and second working head rigidly connected therewith to move along the apparatus tubular body some predesigned distance towards the first control means. The prosthesis secured by one its end on the blood vessel, and by the other—on the second working head, is spread over its whole length.
Then U-shaped staples in the cartridges of second working head are set in motion. This is accomplished by action of flexible pushers activated, in their turn, via second pressure bush, fourth connecting means and second control means of second module of the control mechanism, which are associated with these pushers. As a result, pointed ends of each of the U-shaped staples enter the forming grooves of curvilinear guiding surface of a corresponding removable surface, are curled therein, diverging in opposite directions from one another, pierce the prosthesis wall and surrounding blood vessel wall and return again over a spiral to the curvilinear guiding surface, repeating this rotation if permitted by the given staple length. As a result, the wall of this prosthesis second end gets sutured by wire spirals formed from U-shaped staples to a corresponding area of the blood vessel wall, and the U-shaped staples themselves entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming an oversew suture at the prosthesis second end.
Then, if necessary, the cartridges of second working head are reloaded with standby U-shaped staples. This is accomplished by partial removal of flexible pushers activated, in their turn, via second pressure bush, fourth connecting means and second control means of second module of the control mechanism. As a result, each of the spring-loaded standby U-shaped staples emerges from the through slot of a corresponding cartridge and then, at reverse motion of a corresponding flexible pusher, moves by its action into a recess where a basic U-shaped staples was located before. Now the second head of the apparatus for delivery and fixation is ready for another suturing.
If another suturing is necessary, standby U-shaped staples in the cartridges of second working head are set in motion. This is accomplished by action of flexible pushers activated, in their turn, via second pressure bush, fourth connecting means and second control means of second module of the control mechanism, which are associated with these pushers. As a result, pointed ends of each of the standby U-shaped staples enter the forming grooves of curvilinear guiding surface of a corresponding removable cartridge, are curled therein, diverging in opposite directions from one another, pierce the wall of this prosthesis second end and surrounding blood vessel wall and return again over a spiral to the curvilinear guiding surface, repeating this rotation if permitted by the given staple length. As a result, the wall of the prosthesis second end gets sutured again by wire spirals formed from standby U-shaped staples, to a corresponding area of the blood vessel wall, and the U-shaped staples themselves entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming a second oversew suture at the prosthesis second end.
Then the second end of a delivered and sutured graft is separated from the apparatus for delivery and fixation, both its expandable heads are returned to the original position, this apparatus is set in inoperative position and removed from the graft and from the blood vessel.
The invention will now be described in conjunction with the following drawings in which like reference numerals designate like elements and wherein:
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.
The most preferred embodiments of an apparatus, according to the present invention, are shown in drawing
Proposed apparatus 1 (
Tubular body 3 of apparatus 1 (
Working heads 5 and 7 are located at the free end of tubular body 3 (
First expandable working head 5 (
First expandable working head 5 (
Second expandable working head 7 (
Both working heads 5 and 7 are also provided with means for securing thereon the ends of endovascular graft or stent-graft 13 located on bearing levers 35 and shaped substantially as radial tongues 45 located at one of the ends of these bearing levers 35, near their pivotal connections with corresponding cartridges 9 (
Control mechanism 15 of apparatus 1 is provided with a first control module 17 and second control module 19 linked together via a connecting means 21. Control mechanism 15 (
Each cartridge 9 (
Each cartridge 9 (
Each cartridge 9 (
All cartridges 9 (
Each cartridge 9 (
Bottom 53 of each cartridge 9 (
Forming grooves 71 diverging at an acute angle from one another and from the longitudinal axis of cartridge 9 (
All cartridges 9 of apparatus 1 are substantially shaped as a polyhedral prism with two skewed side faces 73, 75, inclined at an acute angle to one another (
All U-shaped staples 11 are made from one of the materials of a group including stainless steel, titanium and shape memory alloys.
Apparatus 1 is additionally provided with a means for axial precision positioning containing a measuring scale on the surface of tubular body 3, as well as with means for radial precision positioning containing markers—X-ray contrast marks evenly applied on the outer surface of cartridges 9 and serving for orientation of working heads 5 and 7 of apparatus 1 by their operation angle (not shown in the drawings).
Control mechanism 15 includes first and second control modules 17 and 19 joined together via a connecting means 21. Connecting means 21 (
First control module 17 of control mechanism 15 contains a hollow body 93 (
First control module 17 of control mechanism 15 further contains a first pressure handle 105 serving as the second control means. This first pressure handle 105 is pivotally secured to holding handle 101 and has a short free end 107 enclosed in slider 99. Slider 99 is rigidly connected with first axial tube 33 (
In proposed apparatus 1 first bearing bush 29 of first expandable working head 5 is functionally connected via first connecting means—first axial tube 33 with first control means of first control module 17 (FIG. 3,11). First pressure bush 27 is functionally connected via second connecting means—tie 109 with the second control means of first control module 17 of control mechanism 15. Second bearing bush 31 is rigidly connected with distance tube 115 disposed between first and second working heads 5 and 7. First connecting means and second connecting means are enclosed in distance tube 115 and tubular body 3 concentrically with one another, distance tube 115 and this tubular body 3.
Second control module 19 of control mechanism 15 (
Second control module further has a second pressure handle 131 serving as its second control means and pivotally attached to handle 119 or to hollow body 117. This second pressure handle 131 has a short free end 133 enclosed in slider 127. Slider 127 is rigidly connected with tubular tie 135 (
Third bearing bush 37 is connected via third connecting means—tubular tie 135 with first control means of second control module 19 of control mechanism 15. Second pressure bush 41 is functionally connected via fourth connecting means—pressure tube 137 with second control means of second control module 19 of control mechanism 15. Fourth bearing bush 39 is connected with the body of second control module 19 via retaining tube 143. Third connecting means of second module 19—tubular tie 135 is enclosed in retaining tube 143, and said fourth connecting means—pressure tube 137 is located outside this retaining tube 143 and they are all arranged concentrically with one another and with this retaining tube 143.
First and second connecting means—first axial tube 33 and tie 109, link first expandable working head 5 with first control module 17 of control mechanism 15. They are arranged concentrically with one another and enclosed in third connecting means—tubular tie 135, retaining tube 143 and fourth connecting means—pressure tube 137, which are also arranged concentrically with one another and link second working head 7 with second control module 19 of control mechanism 15. Distance tube 115 is located between first and second working heads 5 and 7, outside first and second connecting means and in alignment with third and fourth connecting means. Fourth connecting means—pressure tube 137, is located outside, concentrically with retaining tube 143, third connecting means—tubular tie 135, as well as with first and second connecting means—first axial tube 33 and tie 109, forming a tubular body 3 configured for positioning within a vessel. This tubular body 3, together with connecting means enclosed therein, is rigid in longitudinal direction and flexible in lateral direction.
The proposed apparatus 1 operates on the basis of the proposed method for delivering prosthesis—graft or stent-graft 13 inside a blood vessel, substantially aorta 200, and fixation of prosthesis—graft or stent-graft 13 to the wall of aorta 200, from inside the latter (
At the second step, apparatus 1 for delivery and fixation is set in operative position, inserted into a corresponding blood vessel, in particular, aorta 200, first expandable working head 5 is brought to the securing area, precision axial and radial positioning of apparatus 1 is performed at a given point of the blood vessel—aorta 200 via a measuring scale on the surface of tubular body 3 and via markers—X-ray contrast marks (
Then U-shaped staples 11 in cartridges 9 of first expandable working head 5 are set in motion, which is accomplished by action of flexible pushers 51 activated, in their turn, via first pressure bush 27, second connecting means—tie 109 and second control means—pressure handle 105 of first module 17 of control module 15, which are associated with these pushers. As a result, pointed ends 57 of each U-shaped staple 11 enter forming grooves 71 of curvilinear guiding surface 69 of a corresponding removable cartridge 9, are curled therein, diverging in opposite directions from one another, pierce the wall of prosthesis—graft or stent-graft 13 and surrounding wall of aorta 200 and return again over a spiral to curvilinear guiding surface 69, repeating this rotation if permitted by the given length of staples 11. As a result, the wall of first end of prosthesis—graft or stent-graft 13 gets sutured by wire spirals formed from U-shaped staples 11, to a corresponding wall area of aorta 200, and U-shaped staples 11 themselves entirely emerge from recesses 61 of corresponding cartridges 9 and are released from these cartridges 9, forming an oversew suture at the first end of prosthesis—graft or stent-graft 13 (
Then cartridges 9 of first expandable working head 5 are reloaded with standby U-shaped staples 11. This is accomplished by partial removal of flexible pushers 51 activated, in their turn, via first pressure bush 27, second connecting means—tie 109 and second control means—pressure handle 105 of first module 17 of control mechanism 15, which are associated with these pushers. As a result, each spring-loaded standby U-shaped staple 11 emerges from through slot 55 of a corresponding cartridge 9, and then, at reverse motion of a corresponding flexible pusher 51, moves by its action into recess 61, wherein the basic U-shaped staple 11 was located before. Now, first head 5 of apparatus 1 for delivery and fixation is ready for another suturing.
Then, if another suturing is necessary, standby U-shaped staples 11 in cartridges 9 of first expandable working head 5 are set in motion. This is accomplished by action of flexible pushers 51 activated, in their turn, via first pressure bush 27, second connecting means—tie 109 and second control means—pressure handle 105 of first module 17 of control mechanism 15. As a result, pointed ends 57 of each standby U-shaped staple 11 enter forming grooves 71 of curvilinear guiding surface 69 of a corresponding removable cartridge 9, are curled therein, diverging in opposite directions from one another, pierce the wall of the first end of prosthesis—graft or stent-graft 13 and surrounding wall of aorta 200 and return again over a spiral to curvilinear guiding surface 69, repeating this rotation if permitted by the given length of staples 11. As a result, the wall of the first end of prosthesis—graft or stent-graft 13 gets sutured again by wire spirals formed from standby U-shaped staples 11, to a corresponding wall area of aorta 200, and U-shaped staples 11 themselves entirely emerge from recesses 61 of corresponding cartridges 9 and are released from these cartridges 9, forming a second oversew suture at the first end of prosthesis—graft or stent-graft 13 (
Then prosthesis—if it is thin wall graft 13, which sutured at one end, is spreading, as it is necessary. This is accomplished by rotation of gear 83 of connecting means 21, which enables second control module 19 and second working head 7 rigidly connected therewith to move along tubular body 3 of apparatus 1 a certain, predetermined distance towards first control module 17. Graft 13 secured by one end on the blood vessel—aorta 200, and by the other end—on second working head 7, is being spread over its entire length (
Then U-shaped staples 11 in cartridges 9 of second working head 7 are set in motion. This is accomplished by action of flexible pushers 51 activated, in their turn, via second pressure bush 41, fourth connecting means—pressure tube 137 and second control means—pressure handle 131 of second module 19 of control mechanism 15. Thereby, pointed ends 57 of each U-shaped staple 11 enter forming grooves 71 of curvilinear guiding surface 69 of a corresponding removable cartridge 9, and curled therein, diverging in opposite directions from one another, pierce the wall of prosthesis—graft or stent-graft 13 and surrounding wall of aorta 200 and return again over a spiral to curvilinear guiding surface 69, repeating this rotation if permitted by the given length of staples 11. As a result, the wall of the second end of prosthesis—graft or stent-graft 13 gets sutured by wire spirals formed from U-shaped staples 11, to a corresponding wall area of aorta 200, and U-shaped staples 11 themselves entirely emerge from recesses 61 of corresponding cartridges 9 and are released from these cartridges 9, forming an oversew suture at the second end of prosthesis—graft or stent-graft 13 (
Then, if necessary, cartridges 9 of second working head 7 are reloaded with standby U-shaped staples 11. This is accomplished by partial removal of flexible pushers 51 activated, in their turn, via second pressure bush 41, fourth connecting means—pressure tube 137 and second control means—pressure handle 131 of second module 19 of control mechanism 15, which are associated with these pushers. As a result, each spring-loaded U-shaped staple 11 emerges from through slot 55 of corresponding cartridges 9, and then, at reverse motion of a corresponding flexible pusher 51, moves by its action into recess 61, wherein the basic U-shaped staple 11 was located before. Now second head 7 of apparatus 1 for delivery and fixation is ready for another suturing.
If another suturing is necessary, standby U-shaped staples 11 in cartridges 9 of second working head 7 are set in motion. This is accomplished by action of flexible pushers 51 activated, in their turn, via second pressure bush 41, fourth connecting means—pressure tube 137 and second control means—pressure handle 131 of second module 19 of control mechanism 15, which are associated with these pushers. As a result, pointed ends 57 of each standby U-shaped staple 11 enter forming grooves 71 of curvilinear guiding surface 69 of a corresponding removable cartridge 9, are curled therein, diverging in opposite directions from one another, pierce the wall of the second end of prosthesis—graft or stent-graft 13 and surrounding wall of aorta 200 (
Then the second end of a delivered and sutured prosthesis—graft or stent-graft 13 is separated from apparatus 1 for delivery and fixation, both its expandable working heads 5 and 7 are returned in initial position, this apparatus 1 is set in inoperative position and removed from prosthesis—graft or stent-graft 13 and from the blood vessel—aorta 200.
The application of proposed apparatus 1, as well as realization on the basis of this apparatus of a new and improved method for delivery and fixation of prosthesis—grafts or stent-grafts 13 to the wall of a blood vessel—aorta 200 from within the latter allows, in the authors' opinion, to solve the problem of endoscopic delivery and endoscopic suturing of grafts or stent-grafts 13 to aorta 200 without performing a cavitary operation. Simultaneously, it solves the problem of preventing a sutured graft or stent-graft 13 from shifting from the required position within the blood vessel—aorta 200, which may occur due to peristelsic oscillations of walls of aorta 200 and shakings of a patient's body during its movement.
While this invention has been described in conjunction with specific embodiment 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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 166648 | Feb 2005 | IL | national |
| 170003 | Aug 2005 | IL | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL06/00001 | 1/1/2006 | WO | 00 | 11/12/2008 |
