WO2006082574A2 - Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes - Google Patents

Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes Download PDF

Info

Publication number
WO2006082574A2
WO2006082574A2 PCT/IL2006/000001 IL2006000001W WO2006082574A2 WO 2006082574 A2 WO2006082574 A2 WO 2006082574A2 IL 2006000001 W IL2006000001 W IL 2006000001W WO 2006082574 A2 WO2006082574 A2 WO 2006082574A2
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
working head
cartridges
connecting means
control module
Prior art date
Application number
PCT/IL2006/000001
Other languages
English (en)
Other versions
WO2006082574A3 (fr
Inventor
Edward G. Shifrin
Gennady S. Nickelshpur
Arkady S. Nickelshpur
Wesley S. Moore
Original Assignee
Shifrin Edward G
Nickelshpur Gennady S
Nickelshpur Arkady S
Moore Wesley S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shifrin Edward G, Nickelshpur Gennady S, Nickelshpur Arkady S, Moore Wesley S filed Critical Shifrin Edward G
Priority to US12/159,662 priority Critical patent/US20090132021A1/en
Priority to PCT/IL2006/000001 priority patent/WO2006082574A2/fr
Priority to JP2008548063A priority patent/JP4624466B2/ja
Publication of WO2006082574A2 publication Critical patent/WO2006082574A2/fr
Publication of WO2006082574A3 publication Critical patent/WO2006082574A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B2017/1157—Staplers for performing anastomosis in a single operation applying the staples radially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts

Definitions

  • PCT Patent Cooperation Treaty
  • 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. [0011] Each of the two working heads contains a cartridge group including substantially eight cartridges which are incorporated in the construction of a correspondng working head. All the cartridges are unified and interchangeable, and each of these cartridges is intended for location at least of two fastener means.
  • 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
  • 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. [0014] In the second embodiment the apparatus may be used for delivery, spreading and double-ended fixation of thin wall endovascular grafts.
  • 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.
  • 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, substntially U-shaped staple. This means for retaining is located along the cartridge and contains substantially a sliding lid.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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 acure 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 intgral 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.
  • 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.
  • 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 .
  • 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 apparatus for delivery and fixaion 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.
  • 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 mechnism, which is associated with these pushers.
  • 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.
  • 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.
  • 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 meachanism, which are associated with these pushers.
  • 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.
  • the first head of the apparatus for delivery and fixation is ready for another suturing.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the second head of the apparatus for delivery and fixation is ready for another suturing.
  • standby U-shaped staples in the cartridges of second working head are set in motion.
  • 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.
  • 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.
  • FIG. 1 shows a general view of the proposed apparatus
  • FIG. 2 shows the proposed apparatus during graft suturing
  • FIG. 3 shows a general view of first and second working heads of the apparatus with a graft secured thereon at the moment of suturing the graft first end (first working head deployed);
  • FIG. 4 shows a general view of the second bearing bush
  • FIG. 5 shows the general view of a cartridge in assembly with a sliding lid
  • FIG. 6 shows the general view of a cartridge with arms for its securing and with a through slot in the bottom;
  • FIG. 7 shows a cartridge as viewed from the means for forming the staple
  • FIG. 8 shows the general view of a cartridge as viewed from its bottom and through slot
  • FIG. 9, 10 show cartridge views with diagrams of location of a basic and standby U-shaped staples
  • FIG. 11 shows the apparatus control mechanism
  • FIG. 12 shows an operation diagram of the proposed apparatus. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
  • Proposed apparatus 1 (FIG. 1) comprises a tubular body 3, two expandable working heads 5 and 7 with cartridges 9 intended for location of fastener means, substantially U-shaped staples 11, as well as means for securing the ends of endovascular graft 13 on these heads (FIG. 2).
  • Apparatus 1 is provided with a control mechanism 15 including a first control module 17, second control module 19, connecting means 21 joining them together with a carrying handle 23 and support 25.
  • Tubular body 3 of apparatus 1 (FIG. 1) is configured for positioning within a vessel.
  • Tubular body 3 is rigid in longitudinal direction and flexible in lateral direction, expandable working heads 5 and 7 are located at one its end (FIG. 1, 2), and at the second end - control mechanism 15.
  • Working heads 5 and 7 are located at the free end of tubular body 3 (FIG. 1, 2) and are made expandable to keep both ends of a delivered graft or stent-graft 13 in contact with the inner surface of a blood vessel at the moment of their mutual fixation.
  • Each of working heads 5 and 7 contains a group of cartridges, including substantially eight cartridges 9 each, these cartridges being incorporated in the construction of a corresponding working head 5 or 7. All cartridges 9 are unified and interchangeable and each of them is intended for location at least of two fastener means - U-shaped staples 11. All cartridges 9 are provided with means for retaining therein fastener means, for imparting progressive motion thereto, for forming fastener means - U-shaped staples 11 during their extension from cartridges 9, as well as for storing and feeding standby fastener means.
  • First expandable working head 5 (FIG. 3) contains a first pressure bush 27, first and second bearing bushes 29 and 31, which are arranged in succession one after another beginning from the free end of this working head 5 and in alignment with tubular body 3, as well as a first axial tube 33 rigidly connected with first bearing bush 29 and passing via throgh axial hole in second bearing bush 31.
  • Second bearing bush 31 is shown in more detail in FIG. 4.
  • First expandable working head 5 (FIG. 3) is provided with eight cartridges 9 pivotally mounted by one their ends on first bearing bush 29 and pivotally connected by their other ends with bearing levers 35, pivotally mounted on second bearing bush 31.
  • Second expandable working head 7 located some distance away from first working head 5, contains a third and fourth bearing bushes, 37 and 39 respectively, and second pressure bush 41, which are arranged in succession beginning from the free end of this working head 7 facing first expandable working head 5.
  • Second head 7 also has a second axial tube 43 rigidly connected with third bearing bush 37 and passing via through axial holes in fourth bearing bush 39 and in second pressure bush 41.
  • Third and fourth bearing bushes 37, 39 and second pressure bush 41 are aligned with tubular body 3.
  • Second working head 7 (FIG. 3) is also provided with eight cartridges 9, mounted by one their ends on fourth bearing bush 39 and pivotally connected by their other ends with bearing levers 35, pivotally mounted on third bearing bush 37.
  • First control module 17 is located at the free end of tubular body 3, and second control module 19 is disposed on tubular body 3 near first module 17, between the latter and second expandable working head 7.
  • First control module 17 serves to operate first working head 5, and second control module 19 serves to operate second working head 7.
  • Control modules 17 and 19 are joined together via a connecting means 21 located between them on tubular body 3. It provides both rigid fixation of modules 17 and 19 relative to one another, and reciprocation of second control module 19 and second working head 7 rigidly attached thereto relative to first control module 17 (FIG. 1, 2).
  • Each cartridge 9 (FIG. 5) contains a means for retaining therein at least one basic fastener means - U-shaped staple 11. This means for retaining is located along cartridge 9 and contains a sliding lid 47 with a hole 49 for its opening.
  • Each cartridge 9 (FIG. 3, 5) of apparatus 1 includes at least one means for imparting progressive motion to a fastener means - U- shaped staple 11, and this means contains a flexible .pusher 51, rigid in longitudinal direction and flexible in lateral direction. All flexible pushers 51 are associated by one end respectively with first or second pressure bush 27 or 41 of first or second expandable working head 5 or 7 and located under sliding lid 47 of cartridge 9 to reciprocate in the clearance between the bottom of cartridge 9 and this sliding lid 47.
  • Each cartridge 9 (FIG. 5) of apparatus 1 contains a means for forming fastener means located in this cartridge 9 near one of its ends, as well as at least one basic fastener means - U-shaped staple 11 disposed in this cartridge 9 substantially along its longitidinal axis, with free pointed ends facing this means for forming.
  • U-shaped staple 11 is disposed in cartridge 9 so as to progressively extend therefrom and be formed during this extension.
  • All cartridges 9 (FIG. 5, 6) have a bottom 53 and sliding lid 47 and contain a means for storing at least one standby fastener means, containing a standby U-shaped staple 11.
  • This means for storing contains a slot 55 in the bottom 53 of cartridge 9 (FIG. 6), wherein at least one spring-loaded standby U-shaped staple 11 is located.
  • Standby staple 11 is disposed in this slot 55 substantially along the longitudinal axis of cartridge 9, with free pointed ends 57 facing the means for forming.
  • Standby U-shaped staple 11 is disposed in slot 55 of bottom 53 of cartridge 9 (FIG.
  • slot 55 in bottom 53 of each cartridge 9 is a through one, and standby U-shaped staple 11 is located in this slot 55 immediately under flexible pusher 51 and loaded with spring 59 on the opposite side.
  • Each cartridge 9 (FIG. 5 - 10) of apparatus 1 has a body with a bottom 53 with recess 61 for location at least of one U-shaped staple 11 and through slot 55 for location at least of one more standby fastener means - a like spring-loaded U-shaped staple 11, slots 63 for mounting sliding lid 47, as well as with a longitudinal duct 65 for location at least of one flexible pusher 51.
  • Basic U-shaped staple 11 is disposed in recess 61 of bottom 53 of cartridge 9 in frictional contact with sliding lid 47, which prevents its droppoing out of this recess 61, and standby spring- loaded U-shaped staple 11 is disposed in through slot 55 of bottom 53 of cartridge 9 in frictional contact with flexible pusher 51, which prevents its extension from this through slot 55 before partial removal of flexible pusher 51.
  • each cartridge 9 (FIG. 5 - 10) has a recess 61 for a basic fastener means - U-shaped staple 11.
  • This recess 61 is symmetric about the longitudinal axis of cartridge 9 and parallel with its outer surface 67 (FIG. 5 - 7).
  • Cartridge 9 is provided with a means for forming U-shaped staple 11 during its extension from recess 61, and this means contains a curvilinear guiding surface 69 connecting the bottom of recess 61 for U-shaped staple 11 with outer surfce 67 of cartridge 9.
  • Curvilinear guiding surface 69 has forming grooves 71 (FIG. 5 - 7 and 10), diverging at an acute angle from one another and from the longitudinal axis of cartridge 9.
  • the basic fastener means - U-shaped staple H 5 has pointed free ends 57 and is located in recess 61 of this cartridge 9 in such a way, that its pointed ends 57 face corresponding forming grooves 71 of curvilinear guiding surface 69.
  • Forming grooves 71 diverging at an acute angle from one another and from the longitudinal axis of cartridge 9 (FIG. 5 - 10) provide helical oppositely directed curling of pointed ends 57 of a corresponding U- shaped staple 11 during its movement over recess 61 and forming grooves 71 of curvilinear guiding surface 69 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 (FIG. 5 - 10). The vertex of this acute angle lies on the longitudinal axis of expandable working head 5 or 7. All cartridges 9 are provided with means for connection respectively with first 29 or fourth 39 bearing bushes of first or second working head 5, 7 or with a corresponding bearing lever 35. These means contain arms 77 with holes 79 (FIG. 8), which project from both bases of the polyhedral prism and are integral with this polyhedral prism.
  • 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 (FIG.
  • This connecting means 21 (FIG. 11) contains a holder 81 with a gear 83 pivotally mounted therein and provided with a lock 85 and a mechanic or electric rotary drive connected with shaft 87, as well as two toothed racks 89 and 91 functionally engaged with gear 83, the first whereof - 89 is rigidly connected with first control module 17, and the second, 91 is rigidly connected with second control module 19.
  • the connecting means is additionally provided with handle 23 and support 25 for carrying apparatus 1 and its location on the operation table.
  • First control module 17 of control mechanism 15 contains a hollow body 93 (FIG. 11) having a first and second ends 95 and 97, as well as slider 99 enclosed in this body 93 to reciprocate relative to the latter.
  • Slider 99 is provided with a holding handle 101 rigidly attached thereto and functionally associated with pivotal head 103 located at second end 97 of this hollow body 93. This slider 99 together with pivotal head 103 forms the first control means of first control module 17 of control mechanism 15.
  • 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 (FIG. 3) serving as a first connecting means, and the short free end 107 of pressure handle 105 is functionally associated with tie 109 (FIG. 3, 11) serving as a second connecting means of first control module 17 of control mechanism 15.
  • First pressure handle 105 is provided with a swing lock 111 pivotally mounted on slider 99, and a flat return spring 113 secured by one its end to this pressure handle 105, and by its second end - to holding handle 101.
  • 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 (FIG. 3, 11) contains a hollow body 117 with handle 119 rigidly attached thereto or integral therewith.
  • This body 117 has a first and second ends 121 and 123, is rigidly connected by its first end via holding tube 125 (FIG. 3) with second working head 7 and includes a slider 127 enclosed in body 117 to reciprocate relative to the latter.
  • Slider 127 is functionally associated with pivotal head 129 mounted on second end 123 of this hollow body 117 and forms together with this pivotal head 129 a first control means of 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 (FIG.
  • Second pressure handle 131 is provided with a swing lock 139 pivotally mounted in hollow body 117, as well as a flat return spring 141 secured by one its end to this second pressure handle 131, and by its second end to handle 119 of this body 117.
  • 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.
  • 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.
  • 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 (FIG.12).
  • the proposed method comprises several successive steps. At the first step graft or stent-graft 13 is prepared for delivery, mounted, and its both ends are secured on working heads 5 and 7 of apparatus 1, graft or stent-graft 13 is located between working heads 5 and 7 and crimped to a given outer diameter.
  • 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 (FIG. 12).
  • first working head 5 is deployed in such a way, that the first end of a delivered prosthesis - graft or stent-graft 13 is in contact with the inner surface of the blood vessel - aorta 200 at the moment of their mutual fixation, and cartridges 9 of this expandable working head 5 are located near corresponding suturing points.
  • 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.
  • 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.
  • 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 (FIG. 12).
  • 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.
  • 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.
  • first head 5 of apparatus 1 for delivery and fixation is ready for another suturing.
  • 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.
  • 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 (FIG. 12).
  • prosthesis - if it is thin wall graft 13, which sutured at one end, is spreading, as it is necessary.
  • 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.
  • 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.
  • 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 (FIG. 12).
  • cartridges 9 of second working head 7 are reloaded with standby U-shaped staples 11.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des techniques médicales, plus particulièrement des procédés et un appareil d'apport et de fixation à deux extrémités de prothèses vasculaires, greffes ou stents-grefffes, sur des parois de vaisseaux sanguins dans une direction qui va de l'intérieur de ces vaisseaux jusqu'à leur surface extérieure. L'appareil comprend un corps tubulaire doté de deux têtes de travail extensibles au niveau de son extrémité libre, et de moyens permettant d'y fixer les extrémités de la prothèse. Les têtes comportent huit cartouches chacune, chaque cartouche étant pourvue d'un moyen d'attache de base et d'un moyen d'attache en attente, telles que des agrafes ayant sensiblement la forme d'un U. Un mécanisme de commande est constitué de deux modules de commande reliés ensemble. L'appareil est également doté d'un moyen assurant le positionnement à l'intérieur d'un vaisseau sanguin. Cette invention concerne également un procédé d'apport et de fixation à deux extrémités d'une prothèse endovasculaire sur une paroi de vaisseau sanguin.
PCT/IL2006/000001 2005-02-01 2006-01-01 Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes WO2006082574A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US12/159,662 US20090132021A1 (en) 2005-02-01 2006-01-01 Apparatus and method for delivery, spreading and double-ended fixation of vascular grafts
PCT/IL2006/000001 WO2006082574A2 (fr) 2005-02-01 2006-01-01 Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes
JP2008548063A JP4624466B2 (ja) 2006-01-01 2006-01-01 血管移植片又はステント移植片の供給及び両端固定のための装置及び方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL166648 2005-02-01
IL170003 2005-08-01
PCT/IL2006/000001 WO2006082574A2 (fr) 2005-02-01 2006-01-01 Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes

Publications (2)

Publication Number Publication Date
WO2006082574A2 true WO2006082574A2 (fr) 2006-08-10
WO2006082574A3 WO2006082574A3 (fr) 2008-08-21

Family

ID=36777603

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2006/000001 WO2006082574A2 (fr) 2005-02-01 2006-01-01 Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes

Country Status (2)

Country Link
JP (1) JP4624466B2 (fr)
WO (1) WO2006082574A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008120184A3 (fr) * 2007-03-29 2008-12-11 Es Vascular Ltd Dispositif pour attacher un accessoire médical tubulaire à un passage corporel
WO2009118719A1 (fr) * 2008-03-23 2009-10-01 Es Vascular Ltd. Dispositif de fixation d'une prothèse à un vaisseau
US8734503B2 (en) 2008-11-24 2014-05-27 Vascular Graft Solutions Ltd. External stent
US10052218B2 (en) 2011-04-18 2018-08-21 Vascular Graft Solutions Ltd. Devices and methods for deploying implantable sleeves over blood vessels

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8276802B2 (en) * 2009-07-11 2012-10-02 Tyco Healthcare Group Lp Surgical instrument with double cartridge and anvil assemblies

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5683451A (en) * 1994-06-08 1997-11-04 Cardiovascular Concepts, Inc. Apparatus and methods for deployment release of intraluminal prostheses
US5702419A (en) * 1994-09-21 1997-12-30 Wake Forest University Expandable, intraluminal stents
US6231561B1 (en) * 1999-09-20 2001-05-15 Appriva Medical, Inc. Method and apparatus for closing a body lumen

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5464449A (en) * 1993-07-08 1995-11-07 Thomas J. Fogarty Internal graft prosthesis and delivery system
BR9709867A (pt) * 1996-06-20 2000-01-11 Sulzer Vascutek Ltda Dispositivo para a retenção uma prótese em uma passagrm do corpo dispositivo para a fixação de uma prótese em uma superfìcie interna de uma passagem do corpo, dispositivo protético, prótese e processo para fixar um dispositivo protético, para reparar um vaso e para inserir uma prótese em uma passagem do corpo.
US5824055A (en) * 1997-03-25 1998-10-20 Endotex Interventional Systems, Inc. Stent graft delivery system and methods of use
EP1225948B1 (fr) * 1999-09-20 2007-08-08 ev3 Endovascular, Inc. Dispositif pour fermeture d'une lumiere anatomique
JP2006509595A (ja) * 2002-12-16 2006-03-23 エドリッチ・ヴァスキュラー・ディヴァイシズ，インコーポレイテッド 狭小血管用のマルチプルステープリング器具
AU2003297190A1 (en) * 2002-12-16 2004-07-22 Edrich Vascular Devices, Inc. Endovascular stapler

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5683451A (en) * 1994-06-08 1997-11-04 Cardiovascular Concepts, Inc. Apparatus and methods for deployment release of intraluminal prostheses
US5702419A (en) * 1994-09-21 1997-12-30 Wake Forest University Expandable, intraluminal stents
US6231561B1 (en) * 1999-09-20 2001-05-15 Appriva Medical, Inc. Method and apparatus for closing a body lumen

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008120184A3 (fr) * 2007-03-29 2008-12-11 Es Vascular Ltd Dispositif pour attacher un accessoire médical tubulaire à un passage corporel
US8042720B2 (en) 2007-03-29 2011-10-25 Es Vascular Ltd. Device for affixing of tubular medical accessory to a body passage
WO2009118719A1 (fr) * 2008-03-23 2009-10-01 Es Vascular Ltd. Dispositif de fixation d'une prothèse à un vaisseau
RU2489102C2 (ru) * 2008-03-23 2013-08-10 Текпро ЛЛС Устройство для прикрепления протеза к сосуду
US8734503B2 (en) 2008-11-24 2014-05-27 Vascular Graft Solutions Ltd. External stent
US9265632B2 (en) 2008-11-24 2016-02-23 Vascular Graft Solutions Ltd. Methods of supporting a vein
US9949852B2 (en) 2008-11-24 2018-04-24 Vascular Graft Solutions Ltd. Implant for supporting bodily conduits such as blood vessels or/and grafted vessels
US10052218B2 (en) 2011-04-18 2018-08-21 Vascular Graft Solutions Ltd. Devices and methods for deploying implantable sleeves over blood vessels

Also Published As

Publication number Publication date
JP4624466B2 (ja) 2011-02-02
WO2006082574A3 (fr) 2008-08-21
JP2009521975A (ja) 2009-06-11

Similar Documents

Publication Publication Date Title
US5560532A (en) Apparatus and method for applying surgical staples to body tissue
US20230293168A1 (en) Suture clip deployment device
EP1538993B1 (fr) Dispositif pour la pose de sutures
JP4965105B2 (ja) 外科用ファスナ格納、分配、配置用器具
US20130186935A1 (en) Vascular anastomotic staplers
CA2413904C (fr) Methode de fixation d'un filet maille pour hernie
EP1323384B1 (fr) Dispositif chirurgical avec un mécanisme d'alimentation en élèments de fixation
JP6105620B2 (ja) 縫合のための装置および方法
AU782229B2 (en) A surgical instrument having a fastener delivery mechanism
US6074395A (en) Cannulated tissue anchor insertion system
JP2018512962A (ja) 外科手術用締結具送達および係止機構
JP2005525866A (ja) 外科用縫合器具およびその使用法
JP2008521571A (ja) 弁交換の間にファスナーを供給する装置および方法
WO2006082574A2 (fr) Appareil et procede d'apport et de fixation a deux extremites de greffes vasculaires ou de stents-greffes
US20090228096A1 (en) Fixation of endovascular grafts or stent-grafts
JP6209597B2 (ja) 可変深度の外科手術固定
US20090132021A1 (en) Apparatus and method for delivery, spreading and double-ended fixation of vascular grafts
WO2005079151A2 (fr) Systeme endovasculaire et procede d'apport et de fixation de dispositifs intravasculaires

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2008548063

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 12159662

Country of ref document: US

122 Ep: pct application non-entry in european phase

Ref document number: 06700050

Country of ref document: EP

Kind code of ref document: A2