SHUNT DEFECT CLOSURE SYSTEM

• US 3,874,388 A
• Filed: 02/12/1973
• Issued: 04/01/1975
• Est. Priority Date: 02/12/1973
• Status: Expired due to Term

• Current Assignee: Noel L. Mills, Terry D. King
• Original Assignee: Noel L. Mills, Terry D. King
• Inventors: King, Terry D., Mills, Noel L.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US05/331,559
• Time in Patent Office: 778 Days
• Field of Search: 128/334R,335,348,351,1R 138/89,91,92,93,94
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A method and apparatus for closing off a septal defect or shunt in the intravascular system or the great vessels including a pair of opposed, umbrella-like elements locked together in face-toface relationship on opposite sides of the septal defect, thereby closing it. The dual umbrella-like closure elements are sequentially applied and joined together via an outer catheter inserted into the interior of the heart by means of the jugular vein in the neck or a vein in the groin along with other associated operative elements used within the outer catheter, thereby eliminating the need for open-heart surgery to correct a septal defect or shunt as was heretofore required. For a ventricular septal defect a single umbrella-like element is used which is temporarily held in place by an operative element which is subsequently removed.

Claims

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 substantially 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 relatively 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 structures 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 struts being moveably attached to a centrally located support element for movement from a closed position to an open position or vice versa.

3. The apparatus of claim 1 wherein said operative means includes an obturator wire having attaching means at it 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 further includes an outer catheter serving as a conduit for placing both said umbrella-like structures through the body adjacent to the shunt, said outer catheter having a diameter substantially greater than said obturator wire, said one of said umbrella-like structures being transported through said outer catheter by means of being mounted on the distal portion of said obturator wire and pushing said obturator wire with said one of said umbrella-like structures means thereon through said outer catheter.

5. The apparatus of claim 1 wherein each said umbrella-like structures includes an expanse of relatively flexible material extending between said strut-like members to thereby at least substantially close off the spaces between said strut-like members.

6. The apparatus of claim 1 wherein said umbrella-like structures have their undersides in opposing relationship to each other and said strut-like members are made of resilient material and resiliently bear inwardly toward the opposing umbrella-like structure, thereby securing the opposing umbrella-like structures to the septum.

7. The apparatus of claim 1 wherein said strut-like members include 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 umbrella-like structures is moved toward the septum.

8. The apparatus of claim 1 wherein said operative means includes an obturator wire having attaching means at its distal end for temporary connection to one of said umbrella-like structures and wherein said first one of said umbrella-like structures has a central hub having a connection for temporary connection to said obturator wire;

and wherein said second umbrella-like structure has a central sleeve which can slide over said obturator wire, said central hub and said central sleeve having locking means for locking them together in opposing fashion when on opposite sides of the shunt.

9. The apparatus of claim 8 wherein said locking means comprises a male-female connection between said central hub and said central sleeve, the exterior of said connection means of said central hub forming the male member and the interior of said sleeve forming at least in part the female orifice.

10. The apparatus of claim 9 wherein said male member includes a projection on its mating surface and said female orifice includes an indentation for further mating with said projection and locking the hub and sleeve together.

11. 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 substantially 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 at least one umbrella-like structure 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 umbrella-like structure in its expanded size being at least substantially perpendicular and radial to said central hub means and hence to the central axis of the shunt; and

operative means associated with said expansion means for at least temporarily holding said expansion means on to the shunt defect.

12. The apparatus of claim 11 wherein the underside of said umbrella-like structure has on its distal portions bearing means for bearing against the septum, 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.

13. The apparatus of claim 11 wherein said umbrella-like structure in its final size includes a series of relatively hard strut-like members radially emanating out from said extended central means in a direction at least generally perpendicular thereto, the distal tips of said strut-like members including barb-like structures emanating in a direction at least generally perpendicular thereto, said barbs serving as said bearing means.

14. The apparatus of claim 11 wherein said umbrella-like structure includes an expanse of relatively flexible material extending between said strut-like members to thereby at least substantially close off the spaces between said strut-like members.

15. The apparatus of claim 11 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.

16. A shunt defect closure apparatus for closing off a shunt defect in the septum of for exammvTHE 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 substantially 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 at least one expansion structure being of a material that will be endothelialized into the septum and having an extended, main body with a facing side for contacting the septum surface around the shunt and being extended at least in part in a direction at least generally parallel to the septum surface, and extended central hub means centrally located within said main body and being exteNded in a direction at least generally perpendicular to the septum surface for having pressure applied to it along its extended direction for forcing the distal, end portions of the facing side of said expansion structure against the septum to at least partially close the shunt, the facing side of said expansion structure having on its distal portions anchoring means for anchoring said expansion structure to the septum, when said expansion structure is forced against the septum, said anchoring means comprising 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.

17. The apparatus of claim 16 wherein said expansion structure is an umbrella-like structure having a series of relatively hard strut-like members radially emanating from said extended central means, and having projections at their distal ends, said projections being barb-like structures emanating in a direction at least generally perpendicular to the emanating direction of said strut-like members.

18. The apparatus of claim 17 wherein said umbrella-like structure includes an expanse of relatively flexible material extending between said strut-like members to thereby at least substantially close off the spaces between said strut-like members.

19. The apparatus of claim 17 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.

20. The method of closing off a ventricular septal defect in the intravascular system comprising the following sequential steps:

a. providing a ventricular septal defect closure structure for closing off the ventricular septal 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 septal defect for positioning over and across the septal defect to permanently close it off after being expanded to its larger size, said expansion means 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 defect, said operative means incuding an obturator wire having attaching means at its distal end for temporarily attaching said obturator wire to said expansion means;

b. making a relatively small, minor incision or opening in the body and into a vein having access to the ventricle with the defect;

c. introducing the obturator wire with said closure structure attached to its distal end while in its smaller size into said opening and through the septal defect;

d. expanding said expansion means of said closure structure to its larger size;

e. using said obturator wire to position and attach said expansion means of said closure structure while in its larger size over and across the far side of the septal defect, closing the septal defect;

f. closing off said opening in the body with said obturator wire still attached to said expansion means;

g. allowing said expansion means of said closure structure to become endothelialized over a substantial period 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 the shunt is permanently closed by substantially non-invasive or at least limitedly evasive techniques and without the substantial suturing of the shunt as practiced in the prior art.

21. The method of claim 20 wherein in step (b) the vein used for the opening is the external or internal jugular vein and the incision is made in the neck.

22. 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 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 central hub in at least a generally parallel, 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 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 smaller size in proximity to the shunt to be closed by means of said opening;

d. expanding said umbrella-like structure of said closure structure to its larger size by expanding out said strut-like members;

e. permanently positioning and attaching said umbrella-like structure of said closure structure while in its larger size over and across the shunt, closing the shunt;

f. allowing said umbella-like structure of said closure structure to become endothelialized, further closing off the shunt; and

g. ultimately closing off said opening;

whereby the shunt is permanently closed by substantially non-invasive or at least limitedly evasive techniques and without the substantial suturing of the shunt as practiced in the prior art.

23. The method of claim 22 wherein in step (b) the opening in the body is made by making a relatively small, minor incision to gain access to a vein or artery of the blood circulatory system;

and wherein in step (c) the introduction is made through said vein or artery.

24. The method of claim 22 wherein in step (a) 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 (c) through (d) inclusive are each repeated for said second umbrella-like structure.

25. The method of claim 24 wherein in step (a) said operative means are provided by providing an outer catheter having a cross-sectional area smaller than the shunt and an obturator wire having a diameter substantially smaller than said outer cathether;

and wherein in step (b) the opening in the body is made by making a relatively small minor incision to gain access to a vein or artery; and

wherein in step (c) the introduction is made through said vein or artery and 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 second 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.

26. The method of claim 25 wherein in step (c) there is further included in sub-step (ii) the steps of:

attaching said first umbrella-like structure to the distal end of said obturator 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 emerged out of the distal end of said oUter catheter; and

wherein the step (e) the underside of said first umbrella-like structure is pulled against the distal side of the septum.

27. The method of claim 25 wherein in step (a) in providing said second umbrella-like structure there is further included the providing 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 (c) there is further included in sub-step (ii) the steps of;

sliding said central sleeve of said second umbrella-like structure over said obturator wire and passing said second umbrella-like structure through said outer catheter while in its initial size until said second umbrella-like structure has emerged out of the distal end of said outer catheter; and

wherein in step (e) the underside of said second umbrella-like structure is pushed against the proximal side of the septum.

28. The method of claim 27 wherein in step (a) additional operative means are provided by providing a second, inner catheter having a diameter smaller than said outer catheter and having a central longitudinal 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 (e) for said second umbrella-like structure, the underside of 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 second umbrella-like structure.

29. The method of claim 28 wherein in step (a) the central hub of said first umbrella-like structure is provided with a centrally located, locking male member, the center of which serves as the connecting means for attaching the central hub to the distal end of the obturator wire;

and wherein, the step (e) for said second umbrella-like structure, 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 umbrella-like structures together.

30. The method of claim 28 wherein in step (a) the strut-like members of said second umbrella-like structure are provided with a set 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 member;

and wherein, in the step (d) for said second umbrella-like member, said second umbrella-like structure is expanded by pushing said central sleeve toward said elevating member by means of said inner catheter, causing said elevating struts to push said strut-like members out away from said central sleeve.