Embolic coil introducer system

• US 20050234505A1
• Filed: 06/24/2005
• Published: 10/20/2005
• Est. Priority Date: 01/10/2001
• Status: Active Grant

• Current Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Diaz, Roberto, Elsakka, Mamdouh, Shkolnik, Boris
• Granted Patent: US 7,753,931 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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

An apparatus and method for introducing a medical device deployment system into the vasculature of a human body and then using the deployment system for placing a medical device at a preselected position within a vessel, and an apparatus and method for introducing a medical device deployment system into the vasculature of a human body and then subsequently retrieving the deployment system, where the apparatus and method include an introducer having a detachable and reattachable sheath disposed about a deployment catheter.

Claims

1. An embolic coil introducer system for introducing a deployment catheter and an embolic coil into the vasculature of a body, said introducer system comprising:

a deployment catheter which takes the form of an elongated flexible tube having a lumen extending therethrough and having a proximal section and a distal section;

a detachable and reattachable sheath which takes the form of a flexible tube having a lumen extending therethrough, said sheath having a proximal end and a distal end, said sheath having a longitudinal slit extending through a wall of said sheath and extending from the proximal end to a position intermediate the proximal and distal ends, said sheath being disposed about said deployment catheter through said lumen of said sheath, and said sheath being detachable and reattachable such that when the proximal end of said sheath is raised, said longitudinal slit is forced open and said sheath detaches and reattaches from said deployment catheter through said longitudinal slit;

a vascular occlusive embolic coil being attached to the distal section of said deployment catheter, said embolic coil being disposed within the lumen of said sheath;

a stop which takes the form of a cylindrical member having a lumen extending therethrough, said lumen of said cylindrical member having a diameter approximately equal to an outside diameter of said sheath, said stop fixedly disposed on the periphery of said sheath at a position intermediate the proximal and distal ends of said sheath, and said stop being used to position said sheath while being inserted into the vasculature of the body; and

a zipper which takes the form of a tubular member having a lumen extending therethrough, said lumen of said zipper having a diameter approximately equal to an outside diameter of said sheath, said zipper being slideably disposed about said sheath between the proximal end of said sheath and a position intermediate the proximal and distal ends of said sheath such that when said zipper is moved proximally, said sheath is reattached onto said deployment catheter through said longitudinal slit.

2. An embolic coil introducer system as defined in claim 1, wherein said introducer system includes a holder which takes the form of a generally cylindrical member having a lumen extending therethrough and having a proximal section and a distal section, the lumen at the distal section of said holder having a diameter approximately equal to an outside diameter of said sheath, the lumen at the proximal section of said holder having a diameter approximately equal to an outside diameter of said deployment catheter, the distal section of said holder being slideably disposed about the proximal end of said sheath so that said holder holds said sheath to said catheter, the proximal section of said holder being slideably disposed about the proximal section of said deployment catheter such that when said holder is moved proximally along said catheter, the proximal end of said sheath becomes exposed.

3. An embolic coil introducer system as defined in claim 2, wherein the holder takes the form of a generally cylindrical member having a tapered proximal section.

4. An embolic coil embolic coil introducer system as defined in claim 1, wherein said introducer system includes a tab which takes the form of a projection extending from the proximal end of said sheath from a position generally on the opposite side of said sheath from the longitudinal slit so that when said tab is lifted, said longitudinal slit is forced open and said sheath separates from said deployment catheter through said longitudinal slit.

5. An embolic coil introducer system as defined in claim 4, wherein said tab takes the form of an integral tab having an integral member of said sheath extending from the proximal end of said sheath.

6. An embolic coil introducer system as defined in claim 1, wherein said introducer system includes a purge hole which takes the form of an opening in a wall of said sheath.

7. An embolic coil introducer system as defined in claim 6, wherein said introducer system includes purge holes which take the form of a plurality of openings in the wall of said sheath.

13. An embolic coil introducer as defined in claim 1, wherein the introducer includes a purge hole which takes the form of an opening in a wall of said sheath.

14. An embolic coil introducer as defined in claim 6, wherein the introducer includes purge holes which take the form of a plurality of openings in the wall of said sheath.

8. An embolic coil introducer for introducing a deployment catheter and an embolic coil into the vasculature of a body, said introducer comprising:

a detachable and reattachable sheath which takes the form of a flexible tube having a lumen extending therethrough, said sheath having a proximal end and a distal end, said sheath having a longitudinal slit extending through a wall of said sheath and extending from the proximal end to a position intermediate the proximal and distal ends, said sheath being disposed about a deployment catheter through said lumen of said sheath, and said sheath being detachable such that when the proximal end of said sheath is raised, said longitudinal slit is forced open and said sheath detaches from said deployment catheter through said longitudinal slit;

a stop which takes the form of a cylindrical member having a lumen extending therethrough, said lumen in said stop having a diameter approximately equal to an outside diameter of said sheath, said stop fixedly disposed on the periphery of said sheath at a position intermediate the proximal and distal ends of said sheath, and said stop being used to position said sheath while being inserted into the vasculature of the body; and

a zipper which takes the form of a tubular member having a lumen extending therethrough, said lumen in said zipper having a diameter approximately equal to an outside diameter of said sheath, said zipper being slideably disposed about said sheath between the proximal end of said sheath and a position intermediate the proximal and distal ends of said sheath such that when said zipper is moved proximally, said sheath is reattached onto said deployment catheter through said longitudinal slit.

9. An embolic coil introducer as defined in claim 8, wherein said introducer includes a holder which takes the form of a generally cylindrical member having a lumen extending therethrough and having a proximal section and a distal section, the lumen at the distal section of said holder having a diameter approximately equal to an outside diameter of said sheath, the lumen at the proximal section of said holder having a diameter approximately equal to an outside diameter of said deployment catheter, the distal section of said holder being slideably disposed about the proximal end of said sheath so that said holder holds said sheath to said deployment catheter, the proximal section of said holder being slideably disposed about the proximal section of said deployment catheter such that when said holder is moved proximally along said catheter, the proximal end of said sheath becomes exposed.

10. An embolic coil introducer as defined in claim 9, wherein said holder takes the form of a generally cylindrical member having a tapered proximal section.

11. An embolic coil introducer as defined in claim 8, wherein said introducer includes a tab which takes the form of a member extending from the proximal end of said sheath from a position on said sheath generally on the opposite side of said longitudinal slit so that when said tab is lifted, said longitudinal slit is forced open and said sheath separates from said deployment catheter through said longitudinal slit.

12. An embolic coil introducer as defined in claim 11, wherein said tab takes the form of an integral tab having an integral member of said sheath extending from the proximal end of said sheath.

15. A medical device introducer system for introducing a deployment catheter and medical device into the vasculature of a body, said introducer system comprising:

a deployment catheter which takes the form of an elongated flexible tube having a lumen extending therethrough and having a proximal section and a distal section;

a detachable and reattachable sheath which takes the form of a flexible tube having a lumen extending therethrough, said sheath having a proximal end and a distal end, said sheath having a longitudinal slit extending through a wall of said sheath and extending from the proximal end to a position intermediate the proximal and distal ends, said sheath being disposed about said deployment catheter through said lumen of said sheath, and said sheath being detachable such that when the proximal end of said sheath is raised, said longitudinal slit is forced open and said sheath detaches from said deployment catheter through said longitudinal slit;

a vascular occlusive medical device being attached to the distal section of said deployment catheter, said medical device being disposed within the lumen of said sheath;

a stop which takes the form of a cylindrical member having a lumen extending therethrough, said lumen in said stop having a diameter approximately equal to an outside diameter of said sheath, said stop fixedly disposed on the periphery of said sheath at a position intermediate the proximal and distal ends of said sheath, and said stop being used to position said sheath while being inserted into the vasculature of the body; and

a zipper which takes the form of a tubular member having a lumen extending therethrough, said lumen in said zipper having a diameter approximately equal to an outside diameter of said sheath, said zipper being slideably disposed about said sheath between the proximal end of said sheath and a position intermediate the proximal and distal ends of said sheath such that when said zipper is moved proximally, said sheath is reattached onto said deployment catheter through said longitudinal slit.

16. A medical device introducer system as defined in claim 15, wherein said introducer system includes a holder which takes the form of a generally cylindrical member having a lumen extending therethrough and having a proximal section and a distal section, the lumen at the distal section of said holder having a diameter approximately equal to an outside diameter of said sheath, the lumen at the proximal section of said holder having a diameter approximately equal to an outside diameter of said deployment catheter, the distal section of said holder being slideably disposed about the proximal end of said sheath so that said holder holds said sheath to said deployment catheter, the proximal section of said holder being slideably disposed about the proximal section of said deployment catheter such that when said holder is moved proximally along said catheter, the proximal end of said sheath becomes exposed.

17. A medical device introducer system as defined in claim 16, wherein said holder takes the form of a generally cylindrical member having a tapered proximal section.

18. A medical device introducer system as defined in claim 15, wherein said introducer system includes a tab which takes the form of a projection extending from the proximal end of said sheath from a position generally on the opposite side of said sheath from said longitudinal slit so that when said tab is lifted, said longitudinal slit is forced open and said sheath separates from said deployment catheter through said longitudinal slit.

19. A medical device introducer system as defined in claim 18, wherein said tab takes the form of an integral tab having an integral member of said sheath extending from the proximal end of said sheath.

20. A medical device introducer system as defined in claim 15, wherein said introducer system includes a purge hole which takes the form of an opening in a wall of said sheath.

21. A medical device introducer system as defined in claim 20, wherein said introducer system includes purge holes which take the form of a plurality of openings in a wall of said sheath.

22. A medical device introducer for introducing a deployment catheter and a medical device into the vasculature of a body, said introducer comprising:

a detachable and reattachable sheath which takes the form of a flexible tube having a lumen extending therethrough, said sheath having a proximal end and a distal end, said sheath having a longitudinal slit extending through a wall of said sheath and extending from the proximal end to a position intermediate the proximal and distal ends, said sheath being disposed about said deployment catheter through said lumen of said sheath, and said sheath being detachable such that when the proximal end of said sheath is raised, said longitudinal slit is forced open and said sheath detaches from said deployment catheter through said longitudinal slit;

a stop which takes the form of a cylindrical member having a lumen extending therethrough, said lumen in said stop having a diameter approximately equal to an outside diameter of said sheath, said stop fixedly disposed on the periphery of said sheath at a position intermediate the proximal and distal ends of said sheath, and said stop being used to position said sheath while being inserted into the vasculature of the body; and

a zipper which takes the form of a tubular member having a lumen extending therethrough, said lumen in said zipper having a diameter approximately equal to an outside diameter of said sheath, said zipper being slideably disposed about said sheath between the proximal end of said sheath and a position intermediate the proximal and distal ends of said sheath such that when said zipper is moved proximally, said sheath is reattached onto said deployment catheter through said longitudinal slit.

23. A medical device introducer as defined in claim 22, wherein said introducer includes a holder which takes the form of a generally cylindrical member having a lumen extending therethrough and having a proximal section and a distal section, the lumen at the distal section of said holder having a diameter approximately equal to an outside diameter of said sheath, the lumen at the proximal section of said holder having a diameter approximately equal to an outside diameter of said deployment catheter, the distal section of said holder being slideably disposed about the proximal end of said sheath so that said holder holds said sheath to said deployment catheter, the proximal section of said holder being slideably disposed about the proximal section of said deployment catheter such that when said holder is moved proximally along said catheter, the proximal end of said sheath becomes exposed.

24. A medical device introducer as defined in claim 23, wherein said holder takes the form of a generally cylindrical member having a tapered proximal section.

25. A medical device introducer as defined in claim 22, wherein said introducer includes a tab which takes the form of a projection extending from the proximal end of said sheath from a position generally on the opposite side of said sheath from said longitudinal slit so that when said tab is lifted, said longitudinal slit is forced open and said sheath separates from said deployment catheter through said longitudinal slit.

26. A medical device introducer as defined in claim 23, wherein said tab takes the form of an integral tab having an integral member of said sheath extending from the proximal end of said sheath.

27. A medical device introducer as defined in claim 22, wherein said introducer includes a purge hole which takes the form of an opening in a wall of said sheath.

28. A medical device introducer as defined in claim 27, wherein said introducer includes purge holes which take the form of a plurality of openings in said wall of said sheath.

29. A method for introducing an embolic coil deployment system into the vasculature of a body and then using said deployment system for placing an embolic coil within an aneurysm, said method comprising the steps of:

providing a delivery catheter having a proximal end, a distal end, and a lumen extending therethrough;

providing a deployment catheter having a proximal section, a distal section, and a lumen extending therethrough;

providing an embolic coil introducer comprising a detachable and reattachable sheath having a proximal end, a distal end, and a lumen extending therethrough, said sheath having a longitudinal slit extending through a wall of said sheath, said sheath being disposed about said deployment catheter through said lumen of said sheath;

said introducer also comprising a stop being fixedly disposed on the periphery of said sheath at an intermediate position along said sheath; and

said introducer further comprising a zipper being slideably disposed about said sheath;

providing an embolic coil being attached to the distal section of said deployment catheter, said embolic coil being disposed within the lumen of said sheath;

inserting said delivery catheter into the vasculature of the body;

inserting said deployment catheter and said introducer into the proximal end of said delivery catheter;

raising the proximal end of said sheath slightly to expose said deployment catheter;

moving said deployment catheter distally causing said sheath to detach from said deployment catheter through said longitudinal slit and causing said embolic coil to become exposed from said sheath;

placing said embolic coil within said aneurysm; and

,

removing said deployment catheter, introducer, and delivery catheter from the body.

30. A method for introducing an embolic coil deployment system into the vasculature of a human body and then subsequently retrieving said deployment system from the body, said method comprising the steps of:

providing a delivery catheter having a proximal end, a distal end, and a lumen extending therethrough;

providing a deployment catheter having a proximal section, a distal section, and a lumen extending therethrough;

providing an embolic coil introducer comprising a detachable and reattachable sheath having a proximal end, a distal end, and a lumen extending therethrough, said sheath having a longitudinal slit extending through said sheath, said sheath being disposed about said deployment catheter through the lumen of said sheath;

said introducer also comprising a stop being fixedly disposed on the periphery of said sheath at an intermediate position along said sheath; and

said introducer further comprising a zipper being slideably disposed about said sheath;

providing an embolic coil being attached to the distal end of said deployment catheter, said embolic coil being disposed within the lumen of said sheath;

inserting said delivery catheter into the vasculature of the body;

inserting said deployment catheter and said introducer into the proximal end of said delivery catheter;

raising the proximal end of said sheath slightly to expose said deployment catheter;

moving said deployment catheter distally causing said sheath to detach from said deployment catheter through said longitudinal slit and causing said embolic coil to become exposed from said sheath;

moving said deployment catheter proximally causing said embolic coil to retract into said sheath;

sliding said zipper proximally thereby causing said sheath to reattach about said deployment catheter through said longitudinal slit; and

,

removing said deployment catheter, introducer, and delivery catheter from the body.

31. A method for introducing a medical device deployment system into the vasculature of a body and then using said deployment system for placing a medical device at a preselected position within a vessel, said method comprising the steps of:

providing a delivery catheter having a proximal end, a distal end, and a lumen extending therethrough;

providing a deployment catheter having a proximal section, a distal section, and a lumen extending therethrough;

providing a medical device introducer comprising a detachable and reattachable sheath having a proximal end, a distal end, and a lumen extending therethrough, said sheath having a longitudinal slit extending through a wall of said sheath, said sheath being disposed about said deployment catheter through said lumen of said sheath;

said introducer also comprising a stop being fixedly disposed on the periphery of said sheath at an intermediate position along said sheath; and

said introducer further comprising a zipper being slideably disposed about said sheath;

providing a medical device being attached to the distal section of said deployment catheter, said medical device being disposed within the lumen of said sheath;

inserting said delivery catheter into the vasculature of the body;

inserting said deployment catheter and said introducer into the proximal end of said delivery catheter;

raising the proximal end of said sheath slightly to expose said deployment catheter;

moving said deployment catheter distally causing said sheath to detach from said deployment catheter through said longitudinal slit and causing said medical device to become exposed from said sheath;

placing said medical device at the preselected position within the vessel; and

,

removing said deployment catheter, introducer, and delivery catheter from the body.

32. A method for introducing a medical device deployment system into the vasculature of the human body and then subsequently retrieving said deployment system from the body, said method comprising the steps of:

providing a delivery catheter having a proximal end, a distal end, and a lumen extending therethrough;

providing a deployment catheter having a proximal section, a distal section, and a lumen extending therethrough;

providing a medical device introducer comprising a detachable and reattachable sheath having a proximal end, a distal end, and a lumen extending therethrough, said sheath having a longitudinal slit extending through a wall of said sheath, said sheath being disposed about said deployment catheter through said lumen of said sheath;

said introducer also comprising a stop being fixedly disposed on the periphery of said sheath at an intermediate position along said sheath; and

said introducer further comprising a zipper being slideably disposed about said sheath;

providing a medical device being attached to the distal section of said deployment catheter, said medical device being disposed within the lumen of said sheath;

inserting said delivery catheter into the vasculature of the body;

inserting said deployment catheter and said introducer into the proximal end of said delivery catheter;

raising the proximal end of said sheath slightly to expose said deployment catheter;

moving said deployment catheter distally causing said sheath to detach from said deployment catheter through said longitudinal slit and causing said medical device to become exposed from said sheath;

moving said deployment catheter proximally causing said medical device to retract into said sheath;

sliding said zipper proximally thereby causing said sheath to reattach about said deployment catheter through said longitudinal slit; and

,

removing said deployment catheter, introducer, and delivery catheter from the body.