System for artificial vessel embolization and devices for use therewith

• US 4,819,637 A
• Filed: 09/01/1987
• Issued: 04/11/1989
• Est. Priority Date: 09/01/1987
• Status: Expired due to Term

• Current Assignee: Nfocus Neuromedical, Inc. (Medtronic Plc)
• Original Assignee: Interventional Therapies L L C
• Inventors: Dormandy, Ray H. Jr., Bell, Julie D.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US07/092,079
• Time in Patent Office: 588 Days
• Field of Search: 604/96-103, 604/241-243, 604/283, 604/247, 128/325, 128/344, 128/348.1, 137/846, 137/847
• US Class Current: 606/195
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• CPC Class Codes: Y10T 137/7882 Having exit lip

Abstract

System for artificial vessel embolization comprising a catheter adapted to be inserted into the vessel and having a passage extending therethrough. A balloon delivery catheter is slidably mounted in the passage in the first named catheter. The balloon delivery catheter comprises a flexible elongate element having proximal and distal extremities. A detachable balloon is detachably secured to the distal extremity of the flexible elongate element. An adapter is carried by the proximal extremity of the flexible elongate element permitting inflation and deflation of the detachable balloon. The detachable ballon includes a cylindrical valve base having a bore extending therethrough and a self-sealing valve mounted on the valve base. The detachable balloon is mounted by a friction interference fit between the valve base and the distal extremity of the flexible elongate member. The size of the bore of the valve base is selected to provide the desired detachment force for the detachable balloon.

Claims

1. In a system for artificial vessel embolization, a catheter adapted to be inserted into the vessel and having a passage extending therethrough, a balloon delivery catheter slidably mounted in the passage in the first named catheter, the balloon delivery catheter comprising a flexible elongate element having proximal and distal extremities, the distal extremity having a smooth outer cylindrical surface of a predetermined diameter, a detachable balloon detachably secured to the distal extremity of the flexible elongate element and means carried by the proximal extremity of the flexible elongate element permitting inflation and deflation of the detachable balloon, the detachable balloon including a cylindrical valve base having a smooth surface cylindrical bore extending therethrough, a self-sealing valve mounted on the valve base, said detachable balloon being mounted by a friction interference fit between the valve base and the distal extremity of the flexible elongate member, the size of the bore of the valve base being selected to provide the desired detachment force for the detachable balloon and a lubricant disposed in the bore to reduce static friction between the valve base of the detachable balloon and the flexible elongate element.

2. A system as in claim 1 wherein said self-sealing valve means includes a duck-bill type valve having first and second curved sheet-like vanes and normally straight rod-like reinforcing members carried by the vanes and being bent from the normally straight position to place predetermined closing forces on the vanes.

3. A system as in claim 1 wherein said valve base includes a material which is radiopaque.

4. A system as in claim 1 wherein said detachable balloon is color coded to provide an indication of the detachment force for the detachable balloon.

5. A system as in claim 1 together with an introducer catheter and wherein said first named catheter is disposed in the introducer catheter.

6. A system as in claim 5 together with a sheath and wherein the introducer catheter is disposed in the sheath and means carried by the sheath permitting the introduction of a liquid between the sheath and the introducer catheter.

7. A system as in claim 6 together with means connected to the introducer catheter for introducing a liquid between the introducer catheter and the first named catheter.

8. A system as in claim 5 together with openable clamping means carried by the introducer catheter for clamping off the introducer catheter.

9. A system as in claim 8 wherein said introducer catheter includes a flexible link having a smooth-surfaced passage extending therethrough and wherein said clamping means is mounted on said flexible link.

10. A system as in claim 9 wherein said first named catheter and said delivery catheter extend through said smooth-surfaced passage of said flexible link.

11. A system as in claim 1 for use with a first fitting and wherein the proximal extremity of the flexible elongate element of the balloon delivery catheter is provided with a second fitting adapted to be connected to said first fitting, said second fitting including a shell having a space therein and means disposed within the space in the shell so that when the second fitting is connected to said first fitting there is substantially no unoccupied space in the second fitting.

12. A system as in claim 11 wherein said means disposed within the shell includes a cylindrical member.

13. In a detachable balloon for use in artificial vessel embolization, a cylindrical valve base having a smooth-surfaced cylindrical bore of a predetermined size extending therethrough, the valve base having a radiopaque material incorporated therein so as to make radiopaque material incorporated therein so as to make possible visualization of the valve base in the vessel, a self-sealing prestressed valve carried by the valve base for closing the bore in the valve base and an extensible balloon carried by the valve base, said self-sealing prestressed valve being in the form of a duck bill valve having formed first and second sheets, means binding the side edges of the sheets together, a reinforcing rod secured to each of the sheets and extending longitudinally of the bore, said rods being bent from a normally straight condition to place a permanent yieldable closing force on the sheets and means for securing the sheets to the valve base.

14. A detachable balloon as in claim 13 wherein said valve base and said balloon are formed of a silicone elastomer.

15. A detachable balloon as in claim 13 wherein the size of the bore is changed to change the detachment force for the detachable balloon.

16. A detachable balloon as in claim 13 wherein said valve base is color coded to indicate the detachment force required for the detachable balloon.

17. A detachable balloon as in claim 14 wherein the silicone elastomer is compounded with minimal filler to provide a soft, high elongation compliant balloon shell with a low tensile set and substantially reduced fragmenting or shattering characteristics.

18. In a Luer-type fitting assembly, a flexible elongated element having a flow passage therein and having a proximal extremity a female Luer-type fitting mounted on the proximal extremity of the flexible elongate member so that it extends through the female Luer-type fitting, the female Luer-type fitting having a shell with a space therein through which the flexible elongate member extends, a male Luer-type fitting engaging the female Luer-type fitting and having a protrusion extending into a portion of the space in the shell, the protrusion having a flow passage which receives the proximal extremity of the flexible elongate member and means filling the remaining portion of the space in the shell so that there is a minimum of unoccupied space in the fitting assembly when the female and male Luer-type fittings are interconnected.

19. A fitting as in claim 18 wherein the filling means includes a cylindrical element having a flow passage therein.

20. A kit apparatus for use in artificial vessel embolization comprising a catheter adapted to be inserted into the vessel and having a passage extending therethrough, a balloon delivery catheter comprising a flexible elongate element having proximal and distal extremities, the distal extremity having a smooth outer cylindrical surface of a predetermined diameter, and a plurality of detachable balloons adapted to be detachably secured to the distal extremity of the flexible elongate element, each of the detachable balloons including a cylindrical valve base having a smooth surfaced cylindrical bore extending therethrough and a self-sealing valve mounted on the valve base, said detachable balloons being adapted to be mounted by friction interference fit between the valve base and the distal extremity of the flexible elongate member, each valve base of said detachable balloons having a bore size differing from the bore size of the valve base of the other detachable balloons so that by selecting a detachable balloon having a valve base of a predetermined bore size, the detachment force for the detachable balloon can be selected.

21. A kit apparatus as in claim 20 wherein each of said detachable balloons is color coded to identify the detachment force which is provided by the valve base of the detachable balloon.

22. A kit apparatus as in claim 20 wherein the valve base of each of the detachable valves is formed of an elastomer.

23. A kit apparatus as in claim 20 wherein the valve base of each of the detachable valves has a radiopaque agent incorporated therein.

24. A kit apparatus as in claim 20 wherein a substantially non-absorbing water resistant lubricant is provided in the bore of each of the valve bases of each of the detachable balloons.

25. A kit apparatus as in claim 24 wherein the valve base of each of the detachable valves is formed of a silicon elastomer and wherein the lubricant is silicone based.

26. In a system for artificial vessel embolization, a catheter adapted to be inserted into the vessel and having a passage extending therethrough, a balloon delivery catheter slidably mounted in the passage in the first-named catheter, the balloon delivery catheter comprising a flexible elongate element having proximal and distal extremities, a detachable balloon detachably secured to the distal extremity of the flexible elongate element, means carried by the proximal extremity of the flexible elongate element permitting inflation and deflation of a detachable balloon, an introducer catheter receiving said first named catheter, said introducer catheter including a flexible link having a smooth surface passage extending therethrough, and clamping means carried by the introducer catheter for clamping off the smooth surface passage in the introducer catheter.