APPARATUS AND METHOD FOR DELIVERY, SPREADING AND DOUBLE-ENDED FIXATION OF VASCULAR GRAFTS

• US 20090132021A1
• Filed: 01/01/2006
• Published: 05/21/2009
• Est. Priority Date: 02/01/2005
• Status: Abandoned Application

• Current Assignee: Edward G. Shifrin
• Original Assignee: Edward G. Shifrin
• Inventors: Nickelshpur, Gennady S., Nickelshpur, Arkady S., Shifrin, Edward G., Moore, Wesley S.
• Application Number:
  US12/159,662
• Publication Number:
  US 20090132021A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

Abstract

The present invention relates to medical techniques, more particularly to methods and apparatus for delivery and double-ended fixation of vascular prosthesis—grafts or stent-grafts to blood vessel walls in direction from inside these vessels to their outer surface. The apparatus comprises a tubular body with two expandable working heads at the free end, means for securing thereon the prosthesis end. The heads have eight cartridges each, and each of these cartridges is provided with one basic and one standby fastener means, substantially U-shaped staples. A control mechanism is provided consisting of two control modules joined together. The apparatus is also provided with means for positioning inside a blood vessel. There is further proposed a method for delivery and double-ended fixation of an endovascular prosthesis to a blood vessel wall.

Claims

1. An apparatus for delivery and double-ended fixation of endovascular grafts or stent-grafts, comprising:

a) a tubular body configured for positioning within a vessel, this tubular body being rigid in longitudinal direction and flexible in lateral direction, at one its end there are located two working heads, and at the other end—

a control mechanism;

b) a first working head with cartridges intended for location of fastener means, this working head is rigidly secured at the free end of tubular body and is made expandable to keep the first end of a delivered graft in contact with the inner surface of a blood vessel at the moment of their mutual fixation;

c) a second working head with cartridges intended for location of fastener means, this working head is secured near the free end of tubular body, some distance away from the first working head, aligned with the latter, this working head is also made expandable and serves to keep the second end of the delivered graft in contact with the inner surface of a blood vessel at the moment of their mutual fixation;

d) two cartridge groups, each including eight cartridges, which are incorporated in the construction of first and second working heads respectively, all cartridges are unified and interchangeable and each of the cartridges is intended for location at least of two fastener means, and all 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;

e) a control mechanism, including a first control module for operation of the first working head, which is located at the free end of tubular body opposite to this head, as well as a second control module located on the tubular body between the first control module and second working head, rigidly connected with this second working head and serving for its operation, the first and second control modules being joined together via a connecting means,

whereby a surgical operation may be performed for graft or stent-graft delivery and fixing both its ends to the walls of a blood vessel wall, substantially the aorta, from inside the aorta.

2. The apparatus for delivery and double-ended fixation of endovascular grafts according of claim 1, wherein

f) said second working head 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

g) a connecting means located on said tubular body between the first and second control modules and capable of providing both rigid fixation of modules relative to one another, or reciprocation of second control module and second working head rigidly attached thereto relative to the first control module,

whereby a surgical operation may be performed for 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.

3. The apparatus of claim 1, wherein said first expandable working head contains a first pressure bush and first and second bearing bushes, which are arranged in succession one after another beginning from the free end of this working head and in alignment with said tubular body, as well as a first axial tube rigidly connected with first bearing bush and passing via a through axial hole in second bearing bush.

4. The apparatus of claim 3, wherein said first expandable working head is provided at least with eight cartridges, pivotally mounted by one their ends on said first bearing bush and pivotally connected by their other ends with bearing levers pivotally mounted on said second bearing bush.

5. The apparatus of claim 1, wherein said second working head located some distance away from first expandable working head contains a third and fourth bearing bushes and second pressure bush, which are arranged in succession one after another beginning from the free end of this working head facing the first expandable working head, as well as 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, said third and fourth bearing bushes and second pressure bush being aligned with said tubular body.

6. The apparatus of claim 5, wherein said second working head is provided at least with eight cartridges, secured by one their ends on said fourth bearing bush and pivotally connected by their other ends with bearing levers pivotally mounted on third bearing bush.

7. The apparatus of claim 4 and 6, wherein said first and second working heads are provided with means for securing a delivered graft located on bearing levers.

8. The apparatus of claim 7, wherein said means for securing a delivered graft are shaped substantially as radial tongues located at one of the ends of corresponding bearing levers, near their pivotal connections with corresponding cartridges.

9. The apparatus of claim 1, wherein each of said cartridges contains a means for retaining therein at least one basic fastener means, substantially U-shaped staple, this means for retaining being located along the cartridge and contains substantially a sliding lid.

10. The apparatus of claim 9, wherein each of said cartridges also contains at least one means for imparting progressive motion to said fastener means, substantially U-shaped staple, and this means contains a flexible pusher, rigid in longitudinal direction and flexible in lateral direction.

11. The apparatus of claim 10, wherein each of said cartridges is provided with a flexible pusher, which is associated by one its end with first or second pressure bush of first or second expandable working head respectively and located under said sliding lid to reciprocate in the clearance between the cartridge bottom and said sliding lid.

12. The apparatus of claim 9, wherein each of said cartridges also contains a means for forming fastener means, which is 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 said means for forming, the U-shaped staple being located in the cartridge so that it is capable of progressively extending therefrom and being formed during this extension.

13. The apparatus of claim 11, wherein each of said cartridges has a bottom and sliding lid and contains a means for storing at least one standby fastener means, substantially U-shaped staple, this means for storing contains a slot in the cartridge bottom, wherein the standby U-shaped staple is disposed substantially along the cartridge longitudinal axis, with free pointed ends facing said means for forming, the U-shaped staple being located in the bottom slot of this cartridge substantially under said flexible pusher and capable of extending from this slot by action of a spring and at partial removal of the flexible pusher from the clearance between the cartridge bottom and said sliding lid.

14. The apparatus of claim 13, wherein said slot in the bottom of each of said cartridges is a through one, and the standby U-shaped staple is located in this slot immediately under said flexible pusher and spring-loaded on the opposite side.

15. The apparatus of claim 13, wherein each of said 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 U-shaped staple, slots for mounting said sliding lid, as well as a longitudinal duct for location at least of one said flexible pusher, the basic U-shaped staple being located in said bottom recess of the cartridge body in frictional contact with the sliding lid, which prevents its dropping out of this recess, and the standby spring-loaded U-shaped staple being located in the through bottom slot of the cartridge body in frictional contact with the flexible pusher, which prevents its extension from this through slot before partial removal of this flexible pusher.

16. The cartridge of claim 15, which has a body with a bottom provided with 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 being provided with a means for forming said U-shaped staple during its extension from said recess, and this means contains a curvilinear guiding surface connecting the bottom of said recess for U-shaped staple with the cartridge outer surface.

17. The cartridge of claim 16, which is provided with a means for forming the U-shaped staple during its extension from this cartridge, this means containing a curvilinear guiding surface connecting the bottom of said recess for the U-shaped staple with the cartridge outer surface, said curvilinear guiding surface provided with forming grooves.

18. The cartridge of claim 17, wherein said forming grooves diverge at an acute angle from one another and from the cartridge longitudinal axis.

19. The cartridge of claim 18, wherein at least one basic fastener means, substantially U-shaped staple, has pointed free ends and is located in said body recess of this cartridge in such a way, that its pointed ends face corresponding forming grooves on the curvilinear guiding surface.

20. The cartridge of claim 18, wherein said forming grooves diverge at an acute angle from one another and from the cartridge longitudinal axis, which provides helical oppositely directed curling of pointed ends of a corresponding U-shaped staple during its motion over the body recess and forming grooves of the cartridge curvilinear guiding surface.

21. The cartridge of claim 1, shaped substantially as a polyhedral prism with two skewed side faces inclined at an acute angle to one another, the vertex of this acute angle lying on the longitudinal axis of the expandable working head.

22. The cartridge of claim 21, shaped substantially as a polyhedral prism provided with means for connection with the first or fourth bearing bushes of first or second working head or with a corresponding bearing lever, and these means substantially contain arms with holes, which project from both bases of said polyhedral prism and are integral with this polyhedral prism.

23. The apparatus of claim 1, wherein each of said cartridges contains at least one basic and at least one standby fastener means, substantially U-shaped staples, and these staples are made from one of the materials of a group including stainless steel, titanium and shape memory alloys.

24. The apparatus of claim 1, which is additionally provided with a means for axial precision positioning containing a measuring scale on the surface of said tubular body.

25. The apparatus of claim 1, which is additionally provided with means for radial precision positioning containing markers—

X-ray marks regularly applied on the outer surface of said cartridges and serving for orientation of the apparatus working heads by their operation angle.

26. The apparatus of claim 1, wherein said control mechanism is provided at least with one first control module and at least with one second control module joined together via a connecting means, the first control module being located at the free end of tubular body opposite to the first expandable working head, and said second control module being rigidly connected with the second expandable working head and located on this tubular body near the first control module, between the latter and said second expandable working head.

27. The apparatus of claim 26, wherein said connecting means located on the tubular body between first and second control modules, and providing both their mutual rigid fixation, or reciprocation of second control module and second working head rigidly attached thereto relative to the first control module, substantially contains a holder with a gear pivotally mounted therein and provided with a lock and rotary drive, as well as two toothed racks functionally engaged with this gear, the first of said racks being rigidly connected with first control module, and the second rigidly connected with second control module.

28. The apparatus of claim 27, wherein said connecting means located on the tubular body between said first and second control modules is reciprocable along the axis of this tubular body and additionally supplied with a handle and support for carrying the apparatus and its location on an operation table.

29. The apparatus of claim 27, wherein said connecting means located on the tubular body between said first and second control modules is provided with a gear rotary drive, substantially mechanic or electric.

30. The apparatus of claim 26, wherein said first control module of the control mechanism contains a hollow body having a first and second ends, as well as a reciprocable slider enclosed therein, the slider being provided with a holding handle rigidly attached thereto, functionally associated with a pivotal head located at the second end of this hollow body and forming together with this pivotal head the first control means of first control module of the control mechanism.

31. The apparatus of claim 30, wherein said first control module of the control mechanism also contains a first pressure handle serving as the second control means of first control module of the control mechanism, this first pressure handle is pivotally attached to said holding handle and has a short free end enclosed in said slider, the slider being rigidly connected with the first axial tube serving as a first connecting means, and the short free end of said pressure handle is functionally associated with a tie serving as a second connecting means of first control module of the control mechanism.

32. The apparatus of claim 31, wherein said first pressure handle is provided with a swing lock pivotally secured on said slider, as well as with a flat return spring secured by one its end to this pressure handle, and by its second hand to said holding handle.

33. The apparatus of claim 31, wherein said first bearing bush is connected via first connecting means with said first control means of first control module of the control mechanism, first pressure bush is functionally connected via second connecting means with said second control means of first control module of the control mechanism, and second bearing bush is rigidly connected with a distance tube located between first and second working heads, said first connecting means and said second connecting means being enclosed in said distance tube and tubular body concentrically with one another, said distance tube and this tubular body.

34. The apparatus of claim 26, wherein said second control module of the control mechanism contains a hollow body with a handle rigidly attached thereto, this body has a first and second ends, is rigidly connected by its first end via a retaining tube with the fourth bearing bush of said second working head and also includes a slider reciprocally enclosed in the body, the slider being functionally associated with the pivotal head located at the second end of this hollow body and forming together with this pivotal head the first control means of second control module of the control mechanism.

35. The apparatus of claim 34, wherein the second control module also has a second pressure handle serving as its second control means and pivotally attached to said handle or to the hollow body, this second pressure handle has a short free end enclosed in said slider, the slider being rigidly connected with a tubular tie serving as a third connecting means, and the short free end of said pressure handle functionally associated with a pressure tube serving as the fourth connecting means of the control mechanism and rigidly connected with said second pressure bush.

36. The apparatus of claim 35, wherein said second pressure handle is provided with a swing lock pivotally mounted in said hollow body, as well as a flat return spring secured by one its end to this second pressure handle, and by its second end to said hollow body handle.

37. The apparatus of claim 35, wherein said third bearing bush is connected via third connecting means with said first control means of second control module of the control mechanism, second pressure bush is functionary connected via fourth connecting means with said 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, said third connecting means of second module is enclosed in said retaining tube, and said 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.

38. The apparatus of claim 33 and 37, wherein said first and second connecting means linking the first working head with first control module of the control mechanism are arranged concentrically with one another within said third connecting means, retaining tube and fourth connecting means, which are also arranged concentrically with one another and connect second working head with second control module of the control mechanism, said distance tube being located between first and second working heads outside the first and second connecting means and aligned with said third and fourth connecting means.

39. The apparatus of claim 38, wherein said fourth connecting means located outside, concentrically with said retaining tube, third connecting means, as well as with first and second connecting means, forms a tubular body configured for positioning within a vessel, and this tubular body, together with connecting means enclosed therein, is rigid in longitudinal direction and flexible in lateral direction.

40. A method for delivery and double-ended fixation of a prosthesis, the graft or stent-graft, to the wall of a blood vessel from inside the latter, comprising the following successive steps:

i) preparing the prosthesis for delivery, mounting and securing its both ends on the apparatus working heads, as well as locating the prosthesis between working heads and its crimping to a given outer diameter;

ii) setting the apparatus for delivery and fixation in operative position, inserting it in a corresponding blood vessel, bringing said first expandable working head to the securing area, precision axial and radial positioning in a given area of the blood vessel via a measuring scale on the surface of tubular body and via markers—

X-ray contrast marks, as well as deploying the first expandable working head in such a way, that the first end of a delivered prosthesis is in contact with the inner surface of the blood vessel at the moment of their mutual fixation, and the cartridges of this expandable working head are located near corresponding suturing points;

iii) setting in motion said U-shaped staples of the cartridge group of first expandable working head accomplished by action of said 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, whereby pointed ends of each of the U-shaped staples enter 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 said curvilinear guiding surface, repeating this rotation if permitted by the given staple length, whereby the wall of the prosthesis first end gets sutured by wire spirals formed from U-shaped staples, to a corresponding wall area of the blood vessel, and said U-shaped staples entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming an oversew suture at the first end of the prosthesis;

iv) reloading the cartridge group of first expandable working head with standby U-shaped staples accomplished by partial removal of said 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, whereby 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 said recess, where the basic U-shaped staple was located before, whereby first working head of the apparatus is made ready for another suturing;

v) if another suturing is necessary, setting in motion said standby U-shaped staples of first expandable working head accomplished by action of said 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, whereby 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, pierce the wall of the prosthesis first end and surrounding blood vessel wall and return again over a spiral to said curvilinear guiding surface, repeating this rotation if permitted by the given staple length, whereby the wall of the 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 said standby U-shaped staples entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming a second oversew suture at the first end of this prosthesis;

vi) spreading, if it is necessary, the prosthesis sutured at one end accomplished by turning the gear of said connecting means, 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 module;

vii) setting in motion said U-shaped staples of the cartridge group of second working head accomplished by action of said 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, whereby 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 said curvilinear guiding surface, repeating this rotation if permitted by the given staple length, whereby the wall of the prosthesis second end gets sutured by wire spirals formed from U-shaped staples, to a corresponding area of the blood vessel wall, and said U-shaped staples entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming an oversew suture at the second end of this prosthesis;

viii) reloading the cartridge group of second working head with standby U-shaped staples accomplished by partial removal of said 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, whereby 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 said recess, where the basic U-shaped staple was located before, whereby the second working head of said apparatus for delivery and fixation is made ready for another suturing;

ix) if another suturing is necessary, setting in motion said standby U-shaped staples in cartridges of second working head accomplished by action of said 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, whereby 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 said prosthesis second end and surrounding blood vessel wall and return again over a spiral to said curvilinear guiding surface, repeating this rotation if permitted by the given staple length, whereby the wall of this prosthesis second end gets sutured again by wire spirals formed from standby U-shaped staples, to a corresponding area of this blood vessel wall, and said standby U-shaped staples entirely emerge from recesses of corresponding cartridges and are released from these cartridges, forming a second oversew suture at the second end of a corresponding prosthesis;

x) separating both ends of a delivered and sutured prosthesis from the apparatus for delivery and fixation, returning both its expandable heads to original position;

xi) setting the apparatus for delivery and fixation in inoperative position and its removal from the prosthesis and from the blood vessel.