Shunt defect closure system

Claim 1

79,53 1 THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS: 1. A shunt defect closure apparatus for closing off a shunt defect in the septum of for example the intravascular system comprising: mechanical expansion means having an initial size substantially smaller than the diameter of the shunt defect to be closed during its preliminary handling and a final size sub- stantially larger than the diameter of the shunt defect when it is positioned over and across the shunt defect to permanently close it off after being expanded to its larger size, said expansion means comprising a dual set of umbrella-like structures for placement on opposite sides of the shunt defect, the umbrella- like structures having central hub means for connecting said dual set of umbrella-like structures together through the shunt, each said umbrella-like structures including a series of relativel: hard; strut-like members emanating out from said central means in at least a generally perpendicular, radial direction when said expansion means is in its final size and in at least a generally parallel, axial direction when said expansion means is in its initial size; and operative means removably connected with said expansion means for at least temporarily holding the said expansion means on to the shunt defect after at least one of said umbrella-like struct tures has been expanded out to its final size. 2. The apparatus of Claim 1 wherein said umbrella-like structure comprises a series of supporting struts with flexible material suspended between said struts, said,, o o being moveably attached to a centrally located support element for move- ment from a closed position to an open position or vice-versa. 31 489.252 79,53 1/7 3. The apparatus of Claim 1 wherein said operative means in- cludes an eby eat wire having attaching, means at its distal end for temporarily attaching said obturator wire to one of said umbrella- like structures. 4. The apparatus of Claim 3 wherein said operative means both further includes an outer catheter serving as a conduit for placing said umbrella-like structures through the body adjacent to the shunt, said said outer catheter having a diameter substantially greater than obturator wire, said one of said umbrella-like structures being trans- ported through said outer catheter by means of being mounted on the wire distal portion of said obutrator wire and pushing said obturator through said with said one of said umbrella-like structures means thereon outer catheter. The apparatus of Claim 1 wherein said operative means in- end for tem- cludes an obturator wire having attaching means at its distal wherein said porary connection to one of said ubrella-like structures and having a con- first one of said umbrella-like structures has a central hub obturator wire; and where- nection means for temporary connection to said which can in said second umbrella-like structure has a central sleeve central sleeve slide over said obturator wire, said central hub and said when having locking means for locking them together in opposing fashion on opposite sides of the shunt. 6. The apparatus of Claim 5 wherein said locking means con- and said central prises a male-femanle connection between said central hub hub forming sleeve, the exterior of said connection means of said .central least in part the male menber and the interior of said sleeve forming at the female orifice. 7. The apparatus of Claim 6 wherein said male mnnber includes includes an a projection of its mating surface and said faremale orifice 32 489.252 79,53 1 /7 indentation for further mating with said projection ard locking the hub and sleeve together. 8. The apparatus of Claim 1 wherein each said umbrella-like structures includes an expanse of relatively flexible material extending be- tween said strut-like members to thereby at least substantially close off the spaces between said strut-like members. 9. The apparatus of Claim 1 wherein said umbrella-like struc- tures have their undersides in opposing relationship to each other and said strut-like menbers are made of resilient material and resiliently bear in- wardly towaward the opposing umbrella-like structure, thereby securing the opposing umbrella-like structures to the septum. The apparatus of Claim 1 wherein said strut-like menbers in- clude at their distal tips barb-like means emanating from their underside in a direction at least generally perpendicular thereto for bearing against the septum when each of said unbrella-like structures is moved toward the septum. 11. The method of closing off a shunt defect in the septum of for example the intravascular system carprising the following steps: a) providing a shunt defect closure structure for closing off the shunt defect comprising mechanical expansion means having an initial size substantially smaller than the diameter of the intravascular shunt defect to be closed and a final size substantially larger than the diameter of the shunt defect for positioning over and across the shunt defect to permanently close it off after being expanded to its larger size, said expansion means comprising at least one umbrella-like structure for placement on the side of the shunt, said umbrella-like structure including a central hub having a series of relatively hard, strut-like members emanating out from said cen- tral hub in at least a generally parallel, axial direction when said ex- pansion means is in its initial size and a generally perpendicular, radial 33 489.252 7 9,53 1 size, said umbrella- direction when said expansion means is in its final which can be like structure being made of a. tissue compatible material associated with endothelialized into the septum; and operative means said expan- said expansion means for at least temporarily holding the sion means on to the shunt defect; b) making an opening in the body; c) introducing said closure structure while -in its smaller of said opening; size in proximity to the shunt to be closed by means d) expanding said umbrella-like structure of said closure strut-like manbers; structure to its larger size by expanding out said permanently positioning and attaching said umbrella-like larger size over and structure of said closure structure while in its across the shunt, closing the shunt; closure struc- f) allowing said umbrella-like structure of said the shunt; and ture to become endothelialized, further closing off the shunt is g) ultimately closing off said opening; whereby or at least limitedly permanently closed by substantially non-invasive evasive techniques. and .theut "e u i- u i -t pgarrtlc 1in thu prior Q*t 12. The method of Claim 11 wherein in step the opening in incision to gain ac- the body is made by making a relatively small, minor system; and wherein in cess to a vein or artery of the blood circulatory step the introduction is made through said vein or artery. in providing said 13. The method of Claim 11 wherein in .step providing of a second um- expansion means there is further included the. features as the first um- brella-like structure having the same claimed side of the shunt brella-like structure for placement on the opposite steps through inclu- from said first umbrella-like structure and structure. sive are each repeated for said second umbrella-like 34 489.252 79,531 14. the method of Claim 13 wherein in step said operative means are provided by providing an outer catheter having a cross-sectional area smaller than the shunt ard an obturator wire having a diameter sub- stantially sr-aller than said outer catheter; and wherein in step tie oepning in the body is made by making a relatively -iall minor incision to gain access to a vein or artery; and wherein in step the intro- duction is made through said vein or artery ard includes the following steps: i) inserting said outer catheter through the incision into and through the vein/artery until its distal end is in juxtaposition to the shunt and,.for said first umbrella-like structure, is passed through the shunt but, for the secord umbrella-like structure, is located on the proximal side of the shunt; and ii) moving said umbrella-like structures out of the distal end of said outer catheter. The method of Claim 14 wherein in step there is further included in sub-step "ii" the steps of: attaching said first umbrella-like structure to the distal end of saidobturator wire and inserting the obturator wire with said first umbrella-like structure attached thereto in its initial size into and through the outer catheter until said first umbrella-like structure has anerged out of the distal end of said outer catheter; and wherein in step the underside of said first umbrella- like structure is pulled against the distal side of the septum. 16. The method of Claim 14 wherein in step in providing said second xumbrella-like structure there is further included the pro- vising of a central sleeve with a central orifice having a diameter greater than said obturator wire but less than said outer catheter; and wherein in step there is further included in sup-step "ii" the 489.252 79,531 steps of: sliding said central sleeve of said second umbrella-like struc- ture over said obturator wire and passing said second umbrella-like struc- ture through said outer catheter while in its initial size until said se- cond umbrella-like structure has emerged out of the distal end of said outer catheter; and wherein in step the underside of said second umbrella- like structure is pushed against the proximal side of the septum. 17. The method of Claim 16 wherein in step additional opera- tive means are provided by providing a second, inner catheter having a diameter smaller than said outer catheter and having a central longitu- dinal opening along its length of a diameter larger than the diameter of said obturator wire and being slidable thereon and having a tip at its distal end; and wherein, in the step for said second umbrella-like structure, is pushed against the proximal side of the septum by pushing the tip of said inner catheter against the central sleeve of said se- cond umbrella-like structure. 18. The method of Claim" 17 wherein in step the central hub of said first umbrella-like structure is provided with a centrally lo- cated, locking male member, the center of which serves as the connecting means for attaching the central/w. to the distal end of the obturator wire; and wherein, in the step for said second umbrella-like struc- ture, said inner catheter is used to push the central sleeve of said second umbrella-like structure so that its orifice, which then serves also as a female member, is pushed into the locking male member of said first umbrella-like structure, locking the two imbrella-like structures together. 19. The method of Claim 17 wherein in step the strut-like members of'said-second umbrella-like structure are provided with a set 36 .489.252 79,53 1/75 of elevating struts hingedly connected at one end to the strut-like members at a point removed from said central sleeve and at the other end to a centrally located, leading and elevating meqiber; and where- in, in the step for said second umbrella-like member, said second umbrella-like structure is expanded by pushihg said central sleeve toward said elevating member by means of said inner catheter, caus- ing said elevating struts to push said strut-like nembers out away from said central slee,'e. The method of claim 17 wherein in step the strut-like members of said umbrella-like structures are provided w..,ith resilient, flexible means for automatically and inherently expanding said um- brella-like structures in step once they Emerge. from said outer catheter. 21. A shunt defect closure apparatus for closing off a shunt defect in the septum of for example the intravascular system compris- ing: mechanical expansion means having an initial size substantially .smaller than the diameter of the shunt defect to be closed during its preliminary handling and a final size substantially larger than the dia- meter of the shunt defect when it is positioned over and across the shunt defect to pernanently close it off after being expanded to its larger size, said expansion means comprising at least one umbrella-like struc- ture for placement on one side of the shunt, said umbrella-like structure having central hub means of at least a generally cylindrical shape for having pressure applied to it along its longitudinal axis for forcing the distal end portions of the underside of said umbrella-like structure against the septum to at least partially close the shunt, said umbrella- like structure being of a material that will be endothelialized into the septum; the main surface of -the ubrella-like structure in its expanded size being at least substantially perpendicular and radial to said 37 489.252 79,53 1/75 central hub means and hence to the central axis of th-e shunt; and opera- tive means removably connected with said expansion means for at least ten- porary holding said expansion means on to the shunt defect. 22. The apparatus of Claim 21 werein the underside of said um- brella-like structure has on its distal portions bearing means for bear- ing against the septum when said umbrella-like structure is moved toward the septn, the bearing direction being generally perpendicular to the main surface of said umbrella-like structure and hence parallel to the central axis of the shunt. 23. The apparatus of Claim 21 wherein said umbrella-like struc- ture in its final size includes a series of relatively hard strut-like members radially emanating out from said extended central means in a di- rection at least generally perpendicular thereto, the distal tips of said strut-like members including barb-like structures emanating in a di- rection at least generally perpendicular thereto, said barbs serving as said bearing means. 24. The apparatus of Claim 21 wherein said umbrella-like struc- ture includes an expanse of relatively flexible material extending be- tween said strut-like members to thereby at least substantially close off the spaces between said strut-like members. The apparatus of Claim 21 wherein said strut-like members are made of resilient material and resiliently bear inwardly toward the septum when the umbrella-like structure is in its final size, thereby securing the umbrella-like structure to the septum. 26. A shunt defect closure apparatus for closing off a shunt de- fect in the septum of for example the intravascular system comprising: mechanical expansion means having an initial size substantially smaller than the diameter of the shunt defect to be closed during its pre- liminary handling and a final size substantially larger than the diameter 38 489.252 79,53 of the shunt defect when it is positioned over and across the shunt de- fect to permanently close it off after being expanded to its larger size, said expansion means cinprising at least one expansion structure being an of a material that will be erdothelialized into the septum and having sur- extended, main body with a facing side for ontacting-the septum face around the shunt and being extended at. least in part in a direc- cen- tion at least generally parallel to the septum surface, and extended extended tral hub means centrally located within said main bcdy and being surface for in a direction at least generally perpendicular to the septum having pressure applied to it along its extended direction for forcing structure the distal, end portions of the facing side of said expansion facing side against the septum to at least partially close the shunt, the means of said expansion structure having on its distal portions anchoring for anchoring said expansion structure to.the septum when said expansion structure is forced against the septum, said anchoring means camprising projections extending at least partially in a direction parallel to said extended central means and hence parallel to the central axis of the shunt and perpendicular to the septum surface. 27. The apparatus of Claim 26 wherein said expansion structure is strut-like an umbrella-like structure having a series of relatively hard having members radially emanating from said extended central means, and struc- projections at their distal ends, said projections being barb-like to the tures emanating in a direction at least generally perpendicular emanating direction of said strut-like members. 28. The apparatus of Claim 27 wherein said umbrella-like struc- ture includes an expanse of relatively flexible material extending be- off tween aid strut-like members to thereby at least substantially close the spaces between said strut-like mebers. 29. The apparatus of Claim 27 wherein said strut-like members are made of resilient material and resiliently bear inwardly towerd the 39 489.252 79,53 1/ 7 in its final size, thereby se- septum when the umbrella-like structure is curing the umbrella-like structure to the septum. in the The method of closing off a ventricular septal defect steps: intravascular systen camprising the following sequential .structure for a) providing a ventricular septal defect.closure expan- closing off the ventricular septal defect comprising mechanical than the dia- sion means having an initial size substantially smaller and a final size meter of the intravascular shunt defect to be closed defect for posi- substantially larger than the diameter of the septal close it off tioning over and across the septal defect to pemnanently means being after being expanded to its larger size, said expansion endothelialized into made of a tissue compatible naterial which can be means for the septum; and operative means associated with said expansion to the defect, at least temporarily holding the said expansion means on attaching means said operative means including an obturator wire having wire to said at its distal end for temporarily attaching said obturator expansion means; or opening in the b) making a relatively srall, minor incision with the defect; body and into a vein having access to the ventricle structure. c) introducing the obturator wire with said closure said opening attached to its distal erd while in its smaller size into and through the septal defect; structure to d) expanding said expansion means of said closure its larger size; said ex- e) using said obturator wire to position and attach in its larger size over pansion means of said closure structure while defect; anrd the far side of the septal defect, closing the septal obturator f) closing off said opening in the body with said wire still attached to said expansion means; 489.252 79,53 1 g) allowing said expansion means of said closure a substantial period structure to become endothelialized over of time, further closing off the septal defect; h) reopening the opening.in said body and removing said obturator wire; and i) permanently closing off said opening; whereby non-invasive the shunt is permanently closed by substantially or at least limitedly evasive techniques. aUnd-wietht--e-46 chunt as pr'id in the prior art G' G;uinl -1 the 31. The method of.Claim 29 wherein in step internal jugular vein used for the opening is the external or vein and the incision is made in the neck. 4 89.2 52 79,53 1/75 32. A shunt defect. closure apparatus for closing off a shunt de- fect in the septum of for example the intravascular system comprising: mechanical expansion means having an initial size substantially snaller than the diameter of the shunt defect to be closed during its preliminary handling and a final size substantially larger than the dia- meter of the shunt defect when it is positioned over and across the shunt defect to permanently close it off after being expanded to its larger size, said expansion means comprising a dual set of umbrella- like structures for placement on opposite sides of the shunt defect, the umprella-like structures having central hub means for connecting said dual set of umbrella-like structures together through the shunt, each said umbrella-like structures including a series of relatively hard, strut-like members enanating out from said central means in at least a generally perpendicular, radial direction when said expansion means is in its final size and in at least a generally parallel, axial direc- tion when said expansion means is in its initial size said umbrella- like structures being provided with resilient, flexible means for auto- matically expanding said umbrella-like structures from their initial sizes to their final sizes when said umbrella-like structures are under no radial restraint; and operative means rerovably connected with said expansion means for at least temporarily holding the said expansion means on to the shunt defect after at least one of said umbrella-like structures has been expanded out to its final size. 33. The apparatus of Claim 32 wherein said umbrella-like struc- ture comprises a series of supporting struts with flexible material suspended between said struts, said struts being moveable attached to a centrally located support element for movement from a closed 42 489.252 79,53 1 position to an open position or vice-versa. 34. The apparatus of Claim 33 wherein said supporting struts are themselves made of resilient, flexible material, thereby inherently pro- viding said resilient, flexible means. The apparatus of Claim 33 vwherein said resilient, flexible means canprises a resilient, flexible structure which is separate from said supporting struts but is attached thereto. 36. The method of closing off a shunt defect in the septum of for example the intravascular system comprising the following steps: a) providing a shunt defect closure structure for closing off the shunt defect ccmprising mechanical expansion means having an initial size substantially smaller than the diameter of the intravascular shunt defect to be closed and a final size substantially larger than the dia- meter of the shunt defect for positioning over and across the shunt de- fect to permanently close it off after being expanded to its larger size, said expansion means comprising at least one umbrella-like structure for placement on the side of the shunt, said umbrella-like structure including members emanating out from said central hub in at least a generally paral- lel, axial direction when said expansion means is in its initial size and a generally perpendicular, radial direction when said expansion means is in its final size, said umbrella-like structure including resilient, flex- ible means for automatically expanding said umbrella-like structure is under no radial restraint, said umbrella-like structure being made of a tissue compatible material which can be endothelialized into the septum; and operative means associated with said expansion means for at least temporarily holding the said expansion means on to the shunt defect; b) making an opening in the body; c) introducing said closure structure while in its snaller size under radial restraint in proximity to the shunt to be closed by means 43 489.252 79,53 1 of said opening; d) -expandingsaid urrbrella-like structure of said closure struc- ture to its larger size by automatically expanding oat said strut-like members by eliminating said radial restraint; e) permanently positioning and attaching said umbrella-like struc- ture of said closure structure while in its larger size over and across the shunt, closing the shunt; f) allowing said umbrella-like structure of said closure struc- ture to become endotelialized, further closing off the shunt; and g) ultimately closing off said opening; whereby the shunt is per- manently closed by substantially non-invasive or at least limitedly eva- sive or at lzut limitdly vie. techniques. 4-a1a -i-thc r4 gwtlar ing oL tho Phnt a -pacticod in the prio f 37. The method of Claim 36 wherein in step said operative means includes an outer catheter having a storage capsule section at its distal end, and wherein in step said closure structure is introduced while stored in said storage capsule, the walls of said storage capsule providing said radial restraint. 38. The method of Claim 37 wherein in step in providing said expansion means there is further included the providing of a second umbrella-like structure having the same claimed features as the first umbrella-like structure for placement on the opposite side of the shunt from said first umbrella-like structure and steps through are each done for said second umbrella-like structure. A 2 .n 44 489.252 79,531 /7& FIG. IB. 9 ~92 N 94 FIG. IC. 489.252