Embolus delivery system and method

• US 5,167,624 A
• Filed: 11/09/1990
• Issued: 12/01/1992
• Est. Priority Date: 11/09/1990
• Status: Expired due to Term

• Current Assignee: Catheter Research Incorporated
• Original Assignee: Catheter Research Incorporated
• Inventors: Butler, James R., McCoy, William C.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/612,076
• Time in Patent Office: 753 Days
• Field of Search: 606/200, 606/195, 606/198, 606/151, 606/108, 606/191, 128/831, 128/843, 604/104, 604/60
• US Class Current: 604/60
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

A method and apparatus are provided for passing an embolus into and through the lumen of a catheter to reach a destination in a blood vessel or the like. Once the embolus emerges from the catheter, it lodges in place at the destination in the blood vessel to allow formation of a vessel-occluding blood clot around the embolus.

Claims

1. A method of passing an embolus into and through the lumen of a catheter to reach a destination outside of the catheter, the method comprising the steps of

providing a catheter formed to include an inlet end, an outlet end, and a lumen connecting the inlet to the outlet,

positioning an embolus outside of the catheter in a hollow cartridge coupled to the lumen of the catheter at the inlet end, and

conducting a stream of pressurized fluid through the hollow cartridge to discharge the embolus from the cartridge into the lumen of the catheter through said inlet end and propel the embolus through the lumen so that the embolus exits at the outlet of the catheter and reaches the destination outside of the catheter.

2. The method of claim 1, wherein the positioning step includes the steps of providing a hollow cartridge formed to include a passageway therein containing the embolus and coupling the hollow cartridge to the catheter at the inlet end to place the passageway and the lumen in communication to permit movement of the embolus therebetween through the inlet end.

3. The method of claim 2, wherein the conducting step further includes the steps of providing a supply of fluid and pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid.

4. The method of claim 1, wherein the positioning step includes the steps of providing a cartridge having a tube formed to include a passageway containing the embolus lodged therein in frictional engagement with the tube and clamping one end of the tube to the inlet end of the catheter to place the passageway and the lumen in communication and permit the embolus to move from the passageway into the lumen through said inlet end.

5. The method of claim 4, wherein the conducting step includes the steps of providing a supply of fluid and introducing a predetermined volume of fluid from the supply at a predetermined rate into the passageway formed in the cartridge through a mouth formed in an end of the tube opposite the clamped end to generate the stream of pressurized fluid, and using the stream of pressurized fluid to apply a predetermined amount of work to the embolus to overcome frictional forces between the embolus and the tube and dislodge the embolus during the introducing step.

6. The method of claim 1, wherein the conducting step includes the steps of providing a supply of fluid, pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid, and aiming the stream of pressurized fluid at the embolus in the passageway to cause the embolus to move out of the passageway and into the lumen through said inlet end.

7. The method of claim 1, wherein the embolus is a coiled spring straightened to assume a packed position in the passageway and configured to exert a predetermined force against a wall defining the passageway to retain the embolus temporarily in an initial position within the passageway and the conducting step includes the steps of providing a stream of pressurized fluid and using the stream of pressurized fluid to apply a predetermined amount of work to the embolus to overcome frictional forces between the embolus and the wall defining the passageway and move the embolus out of the passageway from its initial position into the lumen through said inlet end.

8. The method of claim 1, wherein the positioning step further includes the steps of providing a spring having a coiled shape to serve as the embolus, uncoiling the spring to cause it to move to assume a straightened shape, and packing the spring of straightened shape into the passageway, which passageway is sized to block the spring from reforming to its coiled shape so that the spring is lodged temporarily in a fixed position in the passageway by frictional engagement of the spring and a wall defining the passageway, and the conducting step includes the steps of providing a supply of fluid, pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid, and using the stream of pressurized fluid to apply a predetermined amount of work to the spring to overcome frictional forces between the spring and the wall of the passageway and propel the spring from its fixed position in the passageway through the inlet end and through the lumen of the catheter so that the spring exits the outlet end and reforms to assume its coiled shape in the vessel at the destination.

9. A method of delivering an embolus to a destination, the method comprising the steps of

inserting a catheter into a body, the catheter being formed to include an inlet end , an outlet end, and a lumen connecting the inlet end to the outlet end,

guiding the catheter through the body to aim the outlet end of the catheter toward the destination,

supporting an embolus outside of the lumen in an initial position communicating with the inlet end formed in the catheter,

providing a stream of pressurized fluid, and

using the stream of pressurized fluid to apply at least a predetermined amount of work to the embolus to move the embolus from its initial position outside of the lumen through the catheter inlet end, lumen, and outlet end to its destination.

10. The method of claim 9, wherein the using step includes the steps of aiming the stream of pressurized fluid at the embolus and conducting the embolus and the stream of pressurized fluid into the lumen through the inlet end formed in the catheter.

11. The method of claim 9, wherein the using step further includes the steps of providing a supply of fluid and pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid.

12. The method of claim 9, wherein the supporting step includes the steps of providing a hollow cartridge formed to include a passageway containing the embolus lodged temporarily therein in frictional engagement with a wall defining the passageway and coupling the hollow cartridge to the catheter at the inlet end to connect the passageway to the lumen to permit the movement of the embolus therebetween through the inlet end, and the using step further includes the steps of providing a supply of fluid, pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid, and aiming the stream of pressurized fluid to apply a predetermined amount of work to the embolus to overcome frictional forces between the embolus and the wall of the passageway and dislodge the embolus during the using step.

13. The method of claim 9, wherein the supporting step includes the steps of providing a hollow cartridge containing the embolus therein and connecting the cartridge to the inlet end of the catheter to support the embolus in its initial position outside of the lumen.

14. The method of claim 13, wherein the using step includes the step of introducing the stream of pressurized fluid into the hollow cartridge for a predetermined length of time through an inlet end port formed in the hollow cartridge to discharge the embolus from the hollow cartridge through an outlet end port formed in the hollow cartridge into the inlet of the catheter.

15. The method of claim 13, wherein the providing step includes the step of connecting a syringe means having a body filled with a predetermined volume of fluid to an inlet end port formed in the hollow cartridge and moving a plunger in the body to discharge a stream of pressurized fluid from the syringe means into the hollow cartridge through the inlet end port.

16. The method of claim 13, wherein the embolus is a coiled spring uncoiled to assume a straightened, packed position in the hollow cartridge and configured to exert a Predetermined force against an interior wall of the hollow cartridge to retain the embolus in an initial position within the hollow cartridge, and the providing step includes the steps of supplying a predetermined volume of liquid and pressurizing the predetermined volume of liquid to generate the stream of pressurized fluid and provide said predetermined amount of work needed to overcome frictional forces between the embolus and the interior wall of the hollow cartridge.

17. The method of claim 9, wherein the supporting step further includes the steps of providing a spring having a coiled shape to serve as the embolus, uncoiling the spring to cause it to move to assume a straightened shape, and packing the spring of straightened shape into the passageway, which passageway is sized to block the spring from reforming to its coiled shape so that the spring is lodged temporarily in a fixed position in the passageway by frictional engagement of the spring and a wall defining the passageway, and the using step includes the steps of providing a supply of fluid and pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid and apply a predetermined amount of work to the spring to overcome frictional forces between the spring and the wall of the passageway and propel the spring from its fixed position in the passageway through the inlet end and the lumen of the catheter so that the spring exits the outlet end and reforms to assume its coiled shape in the vessel at the destination.

18. The method of claim 9, wherein the providing step includes the step of containing a predetermined volume of fluid in a container having an outlet port and displacing the fluid in the container to discharge a stream of pressurized fluid from the container through the outlet port.

19. The method of claim 18, wherein the using step includes the steps of aiming the stream of Pressurized fluid discharged through the outlet port of the container at the embolus and conducting the embolus and the stream of pressurized fluid into the lumen through the inlet end formed in the catheter so that at least the embolus moves through the lumen to reach the destination.

20. A method of delivering an embolus to a destination in a selected vessel, the method comprising the steps of

inserting a catheter into a body, the catheter being formed to include an inlet end, an outlet end, and a lumen connecting the inlet end to the outlet end,

guiding the catheter through the body to aim the outlet end of the catheter into the selected vessel,

providing an embolus outside of the catheter,

providing a stream of pressurized fluid, and

using the stream of pressurized fluid to propel the embolus into and through the lumen through said inlet end and out said outlet end to its destination in a selected vessel to occlude the vessel.

21. The method of claim 20, wherein the guiding step includes the step of inserting the catheter a distance into the selected vessel before beginning the using step.

22. A method of delivering an embolus to a selected place in a vessel, the method comprising the steps of

inserting an outer catheter into a body, the outer catheter being formed to include a lumen having an inlet end and an outlet end,

guiding the outer catheter through the body to aim the outlet end of the lumen into a passageway of a selected vessel,

inserting an inner catheter into the lumen of the outer catheter, the inner catheter being formed to include an embolus-conducting lumen having an embolus-admitting inlet end and an embolus-discharging outlet end,

moving the inner catheter in the lumen of the outer catheter to position the embolus-discharging outlet end at about the outlet end of the outer catheter so that an embolus discharged from the embolus-conducting lumen is inserted into the selected vessel,

connecting a hollow cartridge containing an embolus to the embolus-admitting inlet end of the inner catheter, and

using a fluid to flush the embolus out of the hollow cartridge and move the embolus into and through the embolus-conducting lumen through said embolus admitting and embolus discharging ends to reach the selected place in the vessel to occlude the vessel.

23. The method of claim 22, wherein the using step further includes the steps of providing a supply of fluid and pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid.

24. The method of claim 22, wherein the guiding step includes the step of inserting the outer catheter a distance into the selected vessel before completion of the moving step so that the outlet of the outer catheter is positioned in the selected vessel before the outlet end of the inner catheter is extended into the selected vessel.

25. The method of claim 22, wherein the connecting step further includes the steps of providing a hollow cartridge formed to include a passageway containing the embolus lodged temporarily therein in frictional engagement with a wall defining the passageway and coupling the hollow cartridge to the catheter at the inlet end to connect the passageway to the lumen to permit the movement of the embolus therebetween through the inlet end, and the using step further includes the steps of providing a supply of fluid, pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid, and aiming the stream of pressurized fluid to apply a predetermined amount of work to the embolus to overcome frictional forces between the embolus and the wall of the passageway and dislodge the embolus during the using step into the inlet end.

26. The method of claim 25, wherein the connecting step further includes the steps of providing a spring having a coiled shape to serve as the embolus, uncoiling the spring to cause it to move to assume a straightened shape, and packing the spring of straightened shape into the passageway, which passageway is sized to block the spring from reforming to its shape so that the spring is lodged temporarily in a fixed position in the passageway by frictional engagement of the spring and a wall defining the passageway, and the using step includes the steps of providing a supply of fluid, pressurizing a predetermined volume of fluid from the supply to generate the stream of pressurized fluid, and employing the stream of pressurized fluid to apply a predetermined amount of work to the spring to overcome frictional forces between the spring and the wall of the passageway and propel the spring from its fixed position in the passageway through the inlet end and the lumen of the catheter so that the spring exits the outlet end and reforms to assume its coiled shape in the vessel at the destination.

27. An embolus delivery system, comprising

a catheter having a lumen,

the lumen having a inlet end,

a cartridge containing an embolus, the cartridge including means for coupling to the catheter to the inlet end of the lumen so that the embolus can pass from the cartridge through the inlet end and into the catheter, and

means for introducing fluid into the cartridge to discharge the embolus from the cartridge into the lumen of the catheter through said inlet end.

28. The system of claim 27, wherein the introducing means includes means for storing a supply of fluid and means for pressurizing a volume of fluid contained in the storing means to generate a stream of pressurized fluid that travels into the cartridge to move the embolus out of the cartridge and into the inlet end of the lumen of the catheter.

29. The system of claim 28, wherein the cartridge is formed to include a passageway containing the embolus lodged therein in frictional engagement with a wall defining the passageway and the pressurizing means provides means for imparting at least a predetermined velocity to the stream of pressurized fluid to cause the fluid to move through the passageway at a rate sufficient to overcome frictional forces between the embolus and the wall, dislodge the embolus, and propel the embolus through the inlet end into and through the lumen of the catheter.

30. The system of claim 29, wherein the embolus is a coiled spring straightened to assume a packed position in the passageway and configured to exert a predetermined force against the wall defining the passageway to retain the embolus temporarily in an initial position within the passageway.