OCCLUSION DEVICE AND METHOD AND APPARATUS FOR INSERTING THE SAME

• US 3,834,394 A
• Filed: 02/23/1972
• Issued: 09/10/1974
• Est. Priority Date: 11/21/1969
• Status: Expired due to Term

• Current Assignee: James A. Hunter, Robert W. Sessions
• Original Assignee: James A. Hunter, Robert W. Sessions
• Inventors: Hunter, James A., Sessions, Robert W.
• Primary Examiner(s): Pace, Channing L.
• Application Number:
  US05/232,323
• Time in Patent Office: 930 Days
• Field of Search: 128/325,348,DIG.9,DIG.16 138/93
• US Class Current: 606/195
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• 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 of effecting the occlusion of a blood vessel by forming an access opening in the body of the patient communicating with the desired blood vessel, introducing an occlusion member in the vessel, moving the member to the desired point of occlusion, and thereat expanding the member to a size greater than the diameter of the vessel whereby the member is substantially immovably retained therein; the member comprising an expandable and contractable body, capable of disposition in a relatively contracted state in which it may be positioned at the desired point of occlusion, or in an expanded state, the body being constructed to contain the means for effecting such expansion; an example of apparatus for practicing the method comprising a catheter in the form of an elongated tubular conduit of a length to extend from said desired point of occlusion to said access opening and constructed at one end for operative connection with such an occlusion member and the other end for operative connection with actuating means cooperable with means disposed in the tubular conduit for effecing transition of said member from one of its states to the other of its states.

Claims

1. A device for effecting the occlusion of a blood vessel comprising an elongated hollow body element having a wall of resilient material, being of a cross-section permitting ready passage through a blood vessel to a desired point of occlusion and inflatable to have a cross section larger than that of said vessel, the distal and proximal end portions of said body element being substantially less deformable than said resilient wall, at least a portion of the proximal end portion being constituted by a perforable body of self-sealing material, and insertion means having a length sufficient to extend from an access opening in the body of the patient to the desired point of occlusion, said means being traversed throughout its length by an inflation lumen and terminating distally in a needle-like element projected through the proximal end of the body of self-sealing material, and adapted to be withdrawn therefrom, whereby the hollow body element may be advanced through the blood vessel to the desired point of occlusion, inflated by fluid introduced through the inflation lumen and deposited in the vessel by disengagement of said needle-like element from said proximal end and withdrawal of said inserting means from such a vessel, with said hollow body element being in operatively self-sustaining fixed engagement with the vessel sidewalls throughout a circumferential band, distributing resulting outwardly directed pressure forces over a substantial unbroken area of the vessel sidewalls, thereby protecting the latter from concentrated puncturing or rupturing forces.

2. A device according to claim 1, wherein said body element is provided with a longitudinally extending passageway which extends therethrough and is not in communication with the hollow interior of said body, forming a bypass between the ends of the latter.

3. A device according to claim 1 which includes a one-way valve in a position to cooperate with the body of self-sealing material to prevent deflation of the inflated body element.

4. A device according to claim 1 wherein said valve comprises at least one flap in a position to rest against the distal end of a perforation through the self-sealing material.

5. A device according to claim 1 wherein said body comprises an elongated base structure of relatively fixed length and said wall is an expandable tubular member disposed in concentric relation with respect to said base structure, and having its end edges connected in fluid-tight relation to said base structure, the latter having a chamber therein communicating with the interior of said expandable tubular member, the latter in its unexpanded state having an outer diameter approximately equal to the maximum diameter of said base structure.

6. A device according to claim 5 wherein said tubular member is secured at its respective ends to said base structure adjacent opposite ends of the latter.

7. In a device for insertion in and effecting the occlusion of a blood vessel, particularly where occlusion is to be for an indefinitely long period, if not permanently, in which an expansible member is adapted to be transported through a blood vessel to a desired point of occlusion by an insertion device constructed to extend from an access opening in the body of the patient to the desired point of occlusion and to detachably support such member at the distal end of such insertion device, whereby the body element forms the lead member of the structure with expansion of the member being effected by actuation of means carried by the insertion device, the improvement in the expansible member including an elongated hollow, fluid-tIght relatively smooth-walled body element having a tubular, expandable intermediate wall portion of resilient material and of a non-expanded cross section permitting ready passage through a blood vessel to a desired point of occlusion and expandable to form and operatively maintain an axially extending circumferential band having a cross section larger than that of such a vessel, the distal and proximal end portions of said body element being substantially less deformable than said resilient wall portion, the proximal end portion having means constructed for detachable engagement with and releasable support by the distal end of such an inserting device, said body element upon expansion and disengagement from the distal end of such insertion device, being adapted to be retained in operative self-sustaining fixed engagement with the vessel sidewall throughout such axially extending circumferential band whereby outwardly directed pressure forces are distributed over a substantial area of the vessel sidewall, thereby protecting the latter from concentrated puncturing or rupturing forces.

8. A member according to claim 7 wherein said body is provided with expansion means permanently disposed therein.

9. A member according to claim 7 wherein said body is adapted to receive means therein for effecting such expansion.

10. A member according to claim 7 wherein said body is provided with a longitudinally extending passageway which extends therethrough and is not in communication with the hollow interior of said body, forming a bypass between the ends of the latter.

11. A member according to claim 8, wherein said expansion means comprises a resilient member disposed in and secured to said hollow body and arranged to exert forces thereon urging said body into its expanded position.

12. A member according to claim 9 wherein said expansion means comprises a coiled spring having its ends secured to said end portions of greater thickness and is operative to urge such end portions toward one another.

13. A member according to claim 11 wherein said body is constructed to receive means for exerting expansion forces thereon in opposition to said resilient means, to effect contraction of the body.

14. A member according to claim 12, wherein said body is constructed to detachably receive elongated relatively rigid means carried by such insertion means for effecting such contraction of the body.

15. A member according to claim 7 wherein said body is constructed for detachable engagement with a fluid conduit whereby the latter may communicate with the interior of the body element for discharging fluid therein to effect said expansion.

16. A member according to claim 15 wherein said body is provided with a port therein constructed to receive the adjacent end of such a fluid conduit, and a valve member disposed in said body, operative to permit entry of fluid into said body interior, but normally prevent fluid flow from said body.

17. A member according to claim 16 wherein said valve member comprises a flap extending across the inner end of said port.

18. A member according to claim 16 wherein said valve member comprises a ball disposed in said body and adapted to close said port, and means carried by said body to retain said ball in cooperable relation adjacent the inner end of said port.

19. A member according to claim 16 wherein said port of the body is provided with internal threads for engagement with cooperable threads on such a fluid conduit.

20. A member according to claim 16 wherein said body has means thereon for aligning the adjacent end of such a conduit with said body for operative engagement therewith.

21. A member according to claim 15 wherein at least a portion of the proximal end of said body is constructed of a self-sealing material which will permit penetration by such a conduit means, and effect a resealing thereat upon disengagement of said conduit means therewith.

22. A member according to claim 7 wherein said body comprises an elongAted base structure of relatively fixed length and said wall is an expandable tubular member disposed in concentric relation with respect to said base structure, and having its end edges connected in fluid-tight relation to said base structure, the latter having a chamber therein communicating with the interior of said expandable tubular member, the latter in its unexpanded state having an outer diameter approximately equal to the maximum diameter of said base structure.

23. A member according to claim 22 wherein said tubular member is secured at its respective ends to said base structure adjacent opposte ends of the latter.

24. In a device for depositing an occlusion member in a blood vessel, particularly where occlusion is to be for an indefinitely long period, if not permanently, in which an occlusion member is adapted to be detachably connected to the distal end of an inserting device to form a detachable lead structure for guiding the insertion device as it is advanced through a blood vessel to the desired point of occlusion and with the occlusion member being adapted to the expanded at the point of occlusion whereby such occlusion member, upon disengagement from the inserting device may be operatively deposited in self-sustaining fixed engagement throughout a circumferential band of the vessel sidewall, the improvement in the inserting device comprising an elongated tubular structure having a length sufficient to extend from an access opening in the body of the patient to the desired point of occlusion and terminating distally in a mounting element adapted to be connected to and detached from the adjacent proximal end portion of said occlusion member to be employed therewith, and means disposed within the tubular structure adapted to effect the expansion of such a body element when mounted thereon, and manually actuatable means at the proximal end of the insertion device for effecting actuation of said expansion-effecting means.

25. A member according to claim 24 wherein said expansion effecting means comprises a wire-like element extending through said tubular structure engageable at its distal end with such an occlusion member operative to effect a transition thereof to a relatively contracted state for insertion in such a blood vessel.

26. A member according to claim 25 wherein said actuating means comprises a manually engageable member connected to the proximal end of said elongated tubular structure, and a second manually engageable member, movable relative to said first member and operatively connected to the proximal end of said wire-like element.

27. A member according to claim 25 wherein said elongated tubular structure is disposed within a second concentrically disposed conduit, defining a fluid passageway therebetween, said second conduit having an opening therein adjacent the distal end thereof, and means adjacent the proximal end of said second conduit for introducing a contrast medium into said passageway for facilitating ascertainment of the location of the occlusion member in such a blood vessel by, for example, X-ray means.

28. A member according to claim 25 wherein said expansion effecting means comprises a fluid conductible through said elongated tubular structure, engageable with such an occlusion member for introducing such fluid into the latter to effect a transition thereof from a relatively contracted state to relatively expanded state.

29. A member according to claim 28 wherein said actuating means comprises a fluid-receiving cylinder and a manually actuatable piston disposed in said cylinder, movement of said piston relative to said cylinder being operative to effect fluid movement in said conduit.

30. A member according to claim 29 wherein the end of said elongated tubular structure constructed for connection to such an occlusion member, is provided with a connection fitting having external threads thereon adapted to mate with complementary internal threads on such an occlusion member.

31. A member according to claim 29 Wherein the end of said elongated tubular structure constructed for connection to such an occlusion member, is provided with a needle-like fitting adapted to be inserted through the proximal end of such an occlusion member.

32. A device for effecting the occlusion of a blood vessel, particulary where occlusion is to be for an indefinitely long period, if not permanently, comprising an elongated hollow, fluid-tight, relatively smooth-walled body element and insertion means therefor, the body element having a tubular-shaped intermediate wall portion of resilient material and of a cross section permitting ready passage through a blood vessel to a desired point of occlusion and expandable to form and operatively maintain an axially extending circumferential band having cross-section larger than that of said vessel, the distal and proximal end portions of said body element being substantially less deformable than said resilient wall portion, the proximal end portion being constructed for mounting on and support by said insertion means, the latter having a length sufficient to extend from an access opening in the body of the patient to the desired point of occlusion, said insertion means terminating distally in a mounting element connectible to and disengageable from cooperable means carried by the proximal end of the body element and including means for expanding the latter, with said body element extending distally of said insertion means and forming the lead structure for guiding the insertion means as the body element is advanced thereby through the blood vessel to the desired point of occlusion, expanded by aid of said means for expanding and deposited by disengagement of the insertion means therefrom, in operatively self-sustaining fixed engagement throughout a circumferential band of the vessel sidewalls to distribute resulting outwardly directed pressure forces thereon over a substantial area and thereby protect the vessel sidewall from concentrated puncturing or rupturing forces.

33. A structure according to claim 32, wherein said hollow body contains a coiled tension spring having its ends so connected to the respective end portions that said spring is operative to urge said body into its expanded state, said insertion means including a wire-like element having one end extending through the proximal end portion of said body adjacent the connection of one end of said spring and bearing on the distal end portion of said body adjacent the connection of the other end of said spring to maintain said body in its contracted state, in opposition to the action of said spring, the opposite end of said wire-like element being operatively connected to actuating means therefor.

34. A structure according to claim 32, wherein said insertion means comprises a fluid conduit, the distal end of which is connected to said body and communicates with the interior of the latter, and said inserting means includes a syringe structure having a movable plunger, with the proximal end of said conduit connected to said syringe structure and communicating with the interior thereof, said expansion effecting means comprising a liquid disposed in said syringe, said conduit and said body, whereby movement of said plunger will force such liquid into said body to expand the same.