Title: Embolic coil introducer system
Abstract: An apparatus system (38) and method for introducing and retrieving a medical device deployment system (50) into the vasculature of a human body at a preselected position within a vessel. The apparatus (38) includes an introducer (10) having a detachable and re-attachable sheath (12) disposed about a deployment catheter (42).
Patent Number: 7,018,394 Issued on 03/28/2006 to Diaz, et al.
| Inventors:
|
Diaz; Roberto (Miami, FL);
Elsakka; Mamdouh (Warsaw, IN);
Shkolnik; Boris (North Miami Beach, FL)
|
| Assignee:
|
Cordis Neurovascular, Inc. (Miami Lakes, FL)
|
| Appl. No.:
|
250845 |
| Filed:
|
January 10, 2002 |
| PCT Filed:
|
January 10, 2002
|
| PCT NO:
|
PCT/US02/00897
|
| 371 Date:
|
December 8, 2003
|
| 102(e) Date:
|
December 8, 2003
|
| PCT PUB.NO.:
|
WO02/054943 |
| PCT PUB. Date:
|
July 18, 2002 |
| Current U.S. Class: |
606/200 |
| Current Intern'l Class: |
A61M 29/00 (20060101) |
| Field of Search: |
606/200,108,194
623/111
600/203
|
References Cited [Referenced By]
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| 4997424 | Mar., 1991 | Little.
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| 5108407 | Apr., 1992 | Geremia et al.
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| 5122136 | Jun., 1992 | Guglielmi et al.
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| 5263964 | Nov., 1993 | Purdy.
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| 5334210 | Aug., 1994 | Gianturco.
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| 5350397 | Sep., 1994 | Palermo et al.
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| 5380290 | Jan., 1995 | Makower et al.
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| 5382259 | Jan., 1995 | Phelps et al.
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| 5389087 | Feb., 1995 | Miraki.
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| 5601600 | Feb., 1997 | Ton.
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| 5817123 | Oct., 1998 | Kieturakis et al.
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| 5853418 | Dec., 1998 | Ken et al.
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| 6063100 | May., 2000 | Diaz et al.
| |
| 6113622 | Sep., 2000 | Hieshima.
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| 6117142 | Sep., 2000 | Goodson et al.
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| 6179857 | Jan., 2001 | Diaz et al.
| |
| 6183491 | Feb., 2001 | Lulo.
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| 6361547 | Mar., 2002 | Hieshima.
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| 6379374 | Apr., 2002 | Hieshima et al.
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| 6695865 | Feb., 2004 | Boyle et al.
| |
Primary Examiner: Ho; (Jackie) Tan-Uyen T.
Parent Case Text
This application is a 371 of PCT/US02/00897 filed on Jan. 10, 2002 which claims
benefit of 60/260,742 filed on Jan. 10, 2001.
Claims
That which is claimed is:
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 about the 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 at about the 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.
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 about the 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 at about the 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.
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.
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 about the 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 at about the 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 about the 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 at about the 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.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to 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. The invention also relates to 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 from the body. This apparatus and
method are particularly suited for introducing an embolic coil deployment system
into the tortuous vasculature of a human brain and then using the deployment system
for placing an embolic coil within an aneurysm.
2. Description of the Prior Art
For many years physicians have been placing various devices within a blood vessel
of the human body in order to treat an aneurysm or to occlude a vessel. Such devices
are placed within the aneurysm or vessel using one of several catheter deployment
systems. These deployment systems transport and release devices at a particular
location within the vessel. The combination of different devices and deployment
systems provide physicians with reliable methods of treating aneurysms.
Various types of devices are placed within an aneurysm or a vessel to occlude
the flow of blood by promoting thrombus formation. Such devices include dilatation
balloons, radiopaque fluids, liquid medications, and embolic coils. Embolic coils
may take the form of helically wound coils, randomly wound coils, coils wound within
other coils, or many other coil configurations. These coils are generally formed
of radiopaque metallic materials, such as platinum, gold, and tungsten, or alloys
of these metals. Often times, several coils are placed at a given location in order
to occlude the flow of blood through the vessel.
One example of an embolic coil design is disclosed in U.S. Pat. No. 6,179,857
entitled, "Stretch Resistant Embolic Coil with Variable Stiffness." The coil is
a helically wound coil in which various combinations of adjacent turns are spot
welded together to create a stretch resistant coil of a preselected flexibility.
Another coil configuration is disclosed in U.S. Pat. No. 6,183,491 entitled, "Embolic
Coil Deployment System with Improved Embolic Coil" which shows an embolic coil
having a relatively flexible proximal portion which resists stretching.
Also, U.S. Pat. No. 5,853,418 entitled "Stretch Resistant Vaso-occlusive Coils,"
discloses a helically wound coil having a polymeric stretch resistant member extending
through the lumen of the coil and fixedly attached to both the distal end and the
proximal end of the coil. Other examples of coil configurations are disclosed in
U.S. Pat. No. 5,334,210, entitled, "Vascular Occlusion Assembly" and U.S. Pat.
No. 5,382,259 entitled, "Vaso-occlusion Coil With Attached Tubular Woven Or Braided
Fibrous Coverings". With all coil designs, it is important that embolic coils remain
very flexible for traveling through vessels when used with catheter deployment systems.
A variety of deployment systems are available for placing embolic coils within
an aneurysm or vessel. An example of such a system is disclosed in U.S. Pat. No.
6,113,622 entitled, "Embolic Coil Hydraulic Deployment System," assigned to the
same assignee as the present patent application. The hydraulic embolic coil deployment
system uses fluid pressure which is applied to the lumen of the deployment catheter
for expanding the distal section radially to release the embolic coil at a preselected position.
Another coil deployment system utilizes a deployment catheter having a socket
at the distal end for retaining a ball which is bonded to the proximal end of the
coil. The ball is placed in the socket within the lumen at the distal end of the
deployment catheter, and the deployment system is then moved into a vessel to place
the coil at a desired position. Then, a pusher wire with a piston at the end is
pushed distally from the proximal end of the deployment catheter to thereby push
the ball out of the socket and release the coil at the desired position. This system
is disclosed in U.S. Pat. No. 5,350,397 entitled, "Axially Detachable Embolic Coil Assembly."
Also, U.S. Pat. No. 5,263,964 entitled, "Coaxial Traction Detachment Apparatus
and Method" discloses another coil deployment system. This system uses glue or
solder for attaching an embolic coil to a guidewire which is, in turn, placed within
a flexible deployment catheter for positioning the coil within the vessel at a
preselected position. Once the coil is at the desired position, the coil is restrained
by the deployment catheter, and the guidewire is pulled from the proximal end of
the deployment catheter causing the coil to be detached from the guidewire and
released from the deployment system.
Additionally, a small diameter vasoocclusive coil deployment system
is disclosed in U.S. patent application Ser. No. 09/580,684 entitled, "Small Diameter
Embolic Coil Hydraulic Deployment System," filed on May 30, 2000 and assigned to
the same assignee as the present patent application. In this system, the distal
end of a cylindrical headpiece is inserted into and bonded with an embolic coil.
The proximal end of the cylindrical headpiece has a diameter approximately equal
to the diameter of a lumen of a deployment catheter allowing the proximal end of
the cylindrical headpiece to be disposed in fluid-tight engagement within the lumen
of the distal section of the deployment catheter. When fluid pressure is applied
to the lumen of the deployment catheter, the wall of the distal section of the
deployment catheter expands radially and releases the cylindrical headpiece along
with the embolic coil.
Examples of other deployment systems are disclosed in U.S. Pat. No. 5,122,136
entitled, "Endovascular Electrolytically Detachable Guidewire Tip For The Electroformation
Of Thrombus In Arteries, Veins, Aneurysms, Vascular Malformations And Arteriovenous
Fistulas" and U.S. Pat. No. 5,108,407 entitled, "Method And Apparatus For Placement
Of An Embolic Coil."
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, an embolic coil introducer
system is provided for introducing a deployment catheter and embolic coil into
the vasculature of a human body. The introducer system includes a deployment catheter
and a vascular occlusive embolic coil attached to the catheter. The system also
includes a sheath which takes the form of an elongated flexible tube and is disposed
about the deployment catheter. The sheath has a longitudinal slit extending through
a wall of the sheath. The sheath is detachable and reattachable such that when
the end of the sheath is raised, the longitudinal slit is forced open and the sheath
detaches from the deployment catheter. The introducer system also includes a stop
which takes the form of a cylindrical member. The stop is fixedly disposed on the
periphery of the sheath and is used to position the sheath while being inserted
into the vasculature of the body. Finally, the introducer system includes a zipper
which takes the form of a tubular member. The zipper is slideably disposed about
the sheath such that when the zipper is moved proximally, the sheath is reattached
onto the deployment catheter through the longitudinal slit.
In accordance with another aspect of the present invention, an embolic coil introducer
is provided for introducing a deployment catheter and embolic coil into the vasculature
of a human body. The introducer includes a detachable and reattachable sheath which
takes the form of a flexible tube. The sheath has a longitudinal slit extending
through the wall of the sheath. The sheath is detachable and reattachable such
that when the end of the sheath is raised, the longitudinal slit is forced open
and the sheath detaches from the deployment catheter. The introducer also includes
a stop which takes the form of a cylindrical member. The stop is fixedly disposed
on the periphery of the sheath and is used to position the sheath while being inserted
into the vasculature of the body. Finally, the introducer includes a zipper which
takes the form of a tubular member. The zipper is slideably disposed about the
sheath such that when the zipper is moved proximally, the sheath is reattached
onto the deployment catheter through the longitudinal slit.
In accordance with another aspect of the present invention, a medical device
introducer
system is provided for introducing a deployment catheter and medical device into
the vasculature of a human body. The introducer system includes a deployment catheter
and a medical device attached to the deployment catheter. The system also includes
a sheath which is disposed about the deployment catheter. The sheath has a longitudinal
slit extending through the wall of the sheath. The sheath is detachable and reattachable
such that when the end of the sheath is raised, the longitudinal slit is forced
open and the sheath detaches from the deployment catheter. The introducer system
also includes a stop which takes the form of a cylindrical member. The stop is
fixedly disposed on the periphery of the sheath and is used to position the sheath
while being inserted into the vasculature of the body. Finally, the introducer
system includes a zipper which takes the form of a tubular member. The zipper is
slideably disposed about the sheath such that when the zipper is moved proximally,
the sheath is reattached onto the deployment catheter through the longitudinal slit.
In accordance with a similar aspect of the present invention, a medical device
introducer system is provided which includes a holder. The holder takes the form
of a cylindrical member with a lumen and is slideably disposed about the sheath
and deployment catheter so that the holder holds the sheath to the deployment catheter.
In accordance with a similar aspect of the present invention, a medical device
introducer system is provided which includes a tapered holder. The tapered holder
takes the form of a generally cylindrical member with a lumen and is slideably
disposed about the sheath and deployment catheter so that the holder holds the
sheath to the deployment catheter.
In accordance with a similar aspect of the present invention, a medical device
introducer system is provided includes a tab extending from the proximal end of
the sheath. The tab is positioned on the sheath generally on the opposite side
of the longitudinal slit so that when the tab is lifted, the longitudinal slit
is forced open and the sheath separates from the deployment catheter through the
longitudinal slit.
In accordance with a similar aspect of the present invention, a medical device
introducer system is provided which includes an integral tab formed by an integral
member of the sheath. The tab is positioned on the sheath generally on the opposite
side of the longitudinal slit so that when the tab is lifted, the longitudinal
slit is forced open and the sheath separates from the deployment catheter through
the longitudinal slit.
In accordance with a similar aspect of the present invention, a medical device
introducer system is provided which includes a purge hole which takes the form
of an opening in the wall of the sheath.
In accordance with a similar aspect of the present invention, a medical device
introducer system is provided which includes a plurality of purge holes which take
the form of openings in the wall of the sheath.
In accordance with another aspect of the present invention, a medical device
introducer
is provided for introducing a deployment catheter and medical device into the vasculature
of a human body. The introducer includes a detachable and reattachable sheath which
takes the form of a flexible tube. The sheath has a longitudinal slit extending
through the wall of the sheath. The sheath is detachable and reattachable such
that when the end of the sheath is raised, the longitudinal slit is forced open
and the sheath detaches from the deployment catheter. The introducer also includes
a stop which takes the form of a cylindrical member. The stop is fixedly disposed
on the periphery of the sheath and is used to position the sheath while being inserted
into the vasculature of the body. Finally, the introducer includes a zipper which
takes the form of a tubular member. The zipper is slideably disposed about the
sheath such that when the zipper is moved proximally, the sheath is reattached
onto the deployment catheter through the longitudinal slit.
In accordance with a similar aspect of the present invention, a medical device
introducer is provided which includes a holder. The holder takes the form of a
cylindrical member with a lumen and is slideably disposed about the sheath and
deployment catheter so that the holder holds the sheath to the deployment catheter.
In accordance with a similar aspect of the present invention, a medical device
introducer is provided which includes a tapered holder. The tapered holder takes
the form of a generally cylindrical member with a lumen and is slideably disposed
about the sheath and deployment catheter so that the holder holds the sheath to
the deployment catheter.
In accordance with a similar aspect of the present invention, a medical device
introducer is provided which includes a tab extending from the proximal end of
the sheath. The tab is positioned on the sheath generally on the opposite side
of the longitudinal slit so that when the tab is lifted, the longitudinal slit
is forced open and the sheath separates from the deployment catheter through the
longitudinal slit.
In accordance with a similar aspect of the present invention, a medical device
introducer is provided which includes an integral tab formed by an integral member
of the sheath. The tab is positioned on the sheath generally on the opposite side
of the longitudinal slit so that when the tab is lifted, the longitudinal slit
is forced open and the sheath separates from the deployment catheter through the
longitudinal slit.
In accordance with a similar aspect of the present invention, a medical device
introducer is provided which includes a purge hole which takes the form of an opening
in the wall of the sheath.
In accordance with a similar aspect of the present invention, a medical device
introducer is provided which includes a plurality of purge holes which take the
form of openings in the wall of the sheath.
In accordance with another aspect of the present invention, a method is provided
for introducing an embolic coil deployment system into the vasculature of a human
body and then using the deployment system for placing an embolic coil within an
aneurysm. The method includes providing a delivery catheter, a deployment catheter,
an embolic coil disposed within the deployment catheter, and an embolic coil introducer.
The introducer includes a detachable and reattachable sheath disposed about the
deployment catheter. The sheath has a longitudinal slit extending through the wall
of the sheath. The introducer has a stop fixedly disposed on the periphery of the
sheath and a zipper slideably disposed about the sheath. The method also includes
inserting the delivery catheter into the vasculature of the human body and inserting
the deployment catheter and the introducer into the delivery catheter. The method
further includes raising the proximal end of the sheath slightly to expose the
deployment catheter and moving the deployment catheter distally causing the sheath
to detach from the deployment catheter through the longitudinal slit and causing
the embolic coil to become exposed from the sheath. Finally, the method includes
placing the embolic coil within the aneurysm then removing the deployment catheter,
introducer, and delivery catheter from the body.
In accordance with another aspect of the present invention, a method is provided
for introducing an embolic coil deployment system into the vasculature of a human
body and then subsequently retrieving the deployment system from the vasculature
of the body. The method includes providing a delivery catheter, a deployment catheter,
an embolic coil disposed within the deployment catheter, and an embolic coil introducer.
The introducer includes a detachable and reattachable sheath disposed about the
deployment catheter. The sheath has a longitudinal slit extending through the wall
of the sheath. The introducer has a stop fixedly disposed on the periphery of the
sheath and a zipper slideably disposed about the sheath. The method also includes
inserting the delivery catheter into the vasculature of the human body and inserting
the deployment catheter and the introducer into the delivery catheter. The method
further includes raising the proximal end of the sheath slightly to expose the
deployment catheter and moving the deployment catheter distally causing the sheath
to detach from the deployment catheter through the longitudinal slit and causing
the embolic coil to become exposed from the sheath. The method also includes moving
the deployment catheter proximally causing the embolic coil to retract into the
sheath, then sliding the zipper proximally thereby causing the sheath to reattach
about the deployment catheter through the longitudinal slit. Finally, the method
includes removing the deployment catheter, introducer, and delivery catheter from
the body.
In accordance with another aspect of the present invention, a method is provided
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. The method includes providing a delivery catheter, a
deployment catheter, a medical device disposed within the deployment catheter,
and a medical device introducer. The introducer includes a detachable and reattachable
sheath disposed about the deployment catheter. The sheath has a longitudinal slit
extending through the wall of the sheath. The introducer has a stop fixedly disposed
on the periphery of the sheath and a zipper slideably disposed about the sheath.
The method also includes inserting the delivery catheter into the vasculature of
the human body and inserting the deployment catheter and the introducer into the
delivery catheter. The method further includes raising the proximal end of the
sheath slightly to expose the deployment catheter and moving the deployment catheter
distally causing the sheath to detach from the deployment catheter through the
longitudinal slit and causing the medical device to become exposed from the sheath.
Finally, the method includes placing the medical device at the preselected position
within the vessel then removing the deployment catheter, introducer, and delivery
catheter from the body.
In accordance with another aspect of the present invention, a method is provided
for introducing a medical device deployment system into the vasculature of a human
body and then subsequently retrieving the deployment system from the vasculature
of the body. The method includes providing a delivery catheter, a deployment catheter,
a medical device disposed within the deployment catheter, and a medical device
introducer. The introducer includes a detachable and reattachable sheath disposed
about the deployment catheter. The sheath has a longitudinal slit extending through
the wall of the sheath. The introducer has a stop fixedly disposed on the periphery
of the sheath and a zipper slideably disposed about the sheath. The method also
includes inserting the delivery catheter into the vasculature of the human body
and inserting the deployment catheter and the introducer into the delivery catheter.
The method further includes raising the proximal end of the sheath slightly to
expose the deployment catheter and moving the deployment catheter distally causing
the sheath to detach from the deployment catheter through the longitudinal slit
and causing the medical device to become exposed from the sheath. The method also
includes moving the deployment catheter proximally causing the medical device to
retract into the sheath then sliding the zipper proximally thereby causing the
sheath to reattach about the deployment catheter through the longitudinal slit.
Finally, the method includes removing the deployment catheter, introducer, and
delivery catheter from the body.
These aspects of the invention and the advantages thereof will be more clearly
understood from the following description and drawings of the preferred embodiment.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an enlarged, sectional view of an introducer in accordance with the
present invention;
FIG. 2 is an enlarged, cross-sectional view of the introducer of FIG. 1 viewed
along the line 2—2 showing a longitudinal slit in a wall of
a sheath;
FIG. 3 is an enlarged, cross-sectional view of the sheath of FIG. 1 viewed along
the line 3—3 showing purge holes;
FIG. 4 is an enlarged view of an introducer system showing the introducer disposed
about a deployment catheter with an embolic coil;
FIG. 5 is an enlarged perspective view of the introducer system showing a holder
being moved proximally along the deployment catheter and a tab being lifted causing
the sheath to separate from the deployment catheter;
FIG. 6 is an enlarged perspective view of the introducer system showing the
deployment catheter and holder being moved distally, forcing the sheath off the
deployment catheter and forcing an embolic coil out the end of the sheath;
FIG. 7 is an enlarged perspective view of the introducer system showing the
deployment catheter and holder being moved proximally, pulling the embolic coil
back into the sheath; and,
FIG. 8 is an enlarged perspective view of the introducer system showing a zipper
being moved proximally, forcing the sheath back onto the deployment catheter.
DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 illustrates an introducer
10 which includes a sheath
12
having a lumen
14. The sheath
12 is approximately 80 centimeters
in length and is formed of a polymer material with a durometer in the range of
about 50D and 70D. The sheath
12 has a diameter of approximately 0.1 centimeters,
and the lumen
14 of the sheath
12 has a diameter slightly greater
than an outside diameter of a deployment catheter
44. The sheath
12
includes a longitudinal slit
34 in the wall of the sheath
12. The
slit
34 is approximately 60 centimeters in length and extends from the proximal
end of the sheath
12 to a position intermediate the proximal and distal
ends of the sheath
12. The sheath
12 also includes an integral tab
24 at the proximal end of the sheath
12. The integral tab
24
is made of a polymer material and is approximately 2 centimeters in length. Finally,
the sheath
12 includes purge holes
36 at the distal end of the sheath
12. The purge holes
36 can vary in diameter but preferably the holes
36 have a diameter of approximately 0.02 centimeters.
The introducer
10 also includes a holder
16 having a lumen
22.
The holder
16 is slideably disposed about the proximal end of the sheath
12. The holder
16 is made from polyethylene but can be formed from
other material like plastic or a polymer. The holder
16 is generally cylindrical
in shape, but the proximal section
18 is tapered. The outside diameter of
the proximal section
18 is approximately 0.07 centimeters while the diameter
of the distal section
20 is approximately 0.1 centimeters. The holder
16
has a length of approximately 11.5 centimeters. A stop
30 is attached to
the periphery of the sheath
12 at an intermediate position along the sheath
12. The stop
30 is cylindrical in shape and is made of nylon but
can also be formed from plastic or a polymer. The length of the stop
30
is approximately 1.3 centimeters while the diameter of the stop
30 can vary
but the preferred diameter is 0.18 centimeters. A zipper
26 is slideably
disposed about the sheath
12 and is approximately 4.5 centimeters in length.
The zipper
26 is generally cylindrical in shape and has a lumen
28.
The zipper
26 is formed of polyethylene but can also be made from plastic
or a polymer. The lumen
28 of the zipper
26 has a diameter slightly
greater than the outside diameter of the sheath
12. The outside diameter
of the zipper
26 can vary but the preferred diameter is 0.18 centimeters.
FIG. 2 illustrates a cross sectional view of the sheath
12 between the
holder
16 and the zipper
26. The longitudinal slit
34 runs
completely through the wall of the sheath
12. The zipper
26 is slideably
disposed about the sheath
12.
FIG. 3 illustrates a cross sectioned view of the sheath
12 between the
stop
30 and the distal end of the sheath
12. Purge holes
36
extend through the wall of the sheath
12.
FIG. 4 illustrates an introducer system
38 which includes the introducer
10 slideably disposed about a deployment catheter
42. The deployment
catheter
42 is an elongated tube with a lumen
48. Preferably, the
proximal section
44 of the deployment catheter
42 is formed of pellethane
material having a durometer in a range of about 60D to 75D. The proximal section
44 is sufficiently flexible to transverse the vasculature of the human body,
but is sufficiently rigid so that it can be pushed distally through the sheath
12. The distal section
46 of the deployment catheter
42 is
preferably formed of a pellethane material having a durometer of between 25D and
55D with a durometer of 40D being the preferred durometer.
The introducer system
38 also includes a winged hub
40 coupled
to the proximal section
44 of a deployment catheter
42. The winged
hub
40 is made from plastic and aids in the insertion of the deployment
catheter
42 into the vascular of the body. Furthermore, the system
38
includes an embolic coil
50 attached to the deployment catheter
42
and disposed within the sheath
12 of the introducer
10. The embolic
coil
50 may take various forms and configurations and may even take the
form of a randomly wound coil, however, a helically wound flexible embolic coil
50 is illustrated in FIG.
4.
FIG. 5 illustrates the holder
16 being moved proximally to expose the
integral tab
24. The integral tab
24 is raised slightly, forcing
the proximal end of the sheath
12 to separate from the deployment catheter
42 through the longitudinal slit
36.
FIG. 6 illustrates the winged hub
40, the deployment catheter
42,
and the holder
16 being moved distally, forcing the sheath
12 to
separate from the deployment catheter
42 through the longitudinal slit
36
and pushing the embolic coil
50 out the distal end of the sheath
12.
FIG. 7 illustrates the winged hub
40, the deployment catheter
42,
and the holder
16 being moved proximally, pulling the embolic coil
