Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
1997-12-19
2001-03-20
Hirsch, Paul J. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S108000, C623S001110
Reexamination Certificate
active
06203547
ABSTRACT:
FIELD OF THE INVENTION
A coil-delivery device for delivery of a vaso-occlusion coil to a vascular target site via a catheter is disclosed. The device includes a wire adapted to be slidably received within the lumen of a catheter or an introducer, the wire having at its distal end a stiff, wavy wire segment adapted to frictionally and releasably engage a vaso-occlusion coil by the end-region inner lumen of the vaso-occlusion coil. Also disclosed are a catheter assembly employing the coil-delivery the device and a method of releasably engaging a vaso-occlusion coil with the device.
BACKGROUND OF THE INVENTION
In a variety of medical procedures, a physician may need to occlude vessels in order to contain bleeding or reduce the risk of hemorrhaging.
There are a variety of devices that have been developed to occlude blood vessels. One of these employs a catheter to deliver one or more vaso-occlusion coils to a vascular target site. The vaso-occlusion coils are typically platinum or other surgical-metal coils that are delivered via a vascular catheter. Typically, the coil is placed in a linear condition in the catheter, and is pushed from the end of the catheter by a pusher wire. As the coil exits the delivery device it assumes a relaxed, convoluted shape at the vascular site.
The coil may be deployed simply by ejecting it from the distal end of the catheter. However, this technique may be unsatisfactory where it is desired to better position the coil in the vessel once it has been ejected from the catheter and has assumed its convoluted shape. To overcome this problem, various release mechanisms have been proposed to allow for positive release of the coil from the end of a pusher wire once the coil is properly positioned at the vascular site. Expandable jaw clamps and electrolytically erodible joints are examples of such mechanisms.
It would be advantageous to provide a coil delivery device and catheter assembly which provides the combined advantages of (i) a coil release mechanism that allows for simple coil loading and release, (ii) positive release once the coil is properly positioned at the target site, (iii) multiple reloading steps for placement of multiple coils at a selected target site, and (iv) operable with coils having a variety of coil diameters.
SUMMARY OF THE INVENTION
In one aspect, the invention includes a coil-delivery assembly for delivery of a plurality of vaso-occlusion coils to a vascular target site. The assembly includes (a) an inner-lumen catheter, (b) an introducer for holding a vaso-occlusion coil in a substantially linear condition, (c) a coil-delivery device for releasably engaging a coil in the introducer and transferring the coil into and through the catheter, and (d) a structure for disengaging the coil, with such advanced through the catheter at the distal end thereof, to effect coil release from the delivery device.
The introducer has an end region adapted to be mated with the proximal end of the catheter for transferring a coil from the introducer into the catheter. The delivery device has a wire adapted to be advanced axially within the lumen of the catheter. This wire has a proximal end region adapted to be manipulated to advance the wire within the catheter, and a distal end region having engagement structure adapted to releasably engage the end region of vaso-occlusion coil, with the coil held in the introducer. In one embodiment, each coil has an end-region inner lumen and the engagement structure includes a stiff wavy wire segment for frictionally engaging said inner lumen.
The structure for disengaging the coil from the delivery device may include a one-way valve at the catheter's distal end that permits the coil to be advanced in an inside-to-outside direction only, with coil release being effected by slight retraction of the delivery device. Alternatively, the device may include an outer sleeve through which the wire in the device can be moved axially by manipulating the proximal end of the wire. In this embodiment, the coil-disengaging structure includes a distal sleeve end adapted to engage the coil, as the wire is retracted into the sleeve, to dislodge the coil from the wire.
Multiple coils used in the assembly may each be supplied in a tube having an open access end, where the introducer is adapted to mate with the access end, for transferring a coil from a tube to the introducer.
In another aspect, the invention includes a coil-delivery device for delivery to a vascular target site via an inner-lumen catheter, an elongated, flexible vaso-occlusion coil having an end-region inner lumen. The device includes a wire adapted to be advanced axially within the lumen of the catheter. The wire has a proximal end region adapted to be manipulated to advance the wire within the catheter, and a distal end region forming or attached to a stiff wavy wire segment adapted to frictionally and releasably engage the vaso-occlusion coil by insertion of the wavy wire segment into the end-region inner lumen of the coil. The device is used to advance the coil into and through a catheter and to allow positive release of the coil once it has been properly positioned at the target site.
The wire may have a radial enlargement adjacent the wavy wire segment to limit axial movement of the wire into the coil's inner lumen. The wavy wire segment may have a substantially sinusoidal shape extending at least one full wave cycle, where the ratio of wave amplitude to wavelength is, for example, between about 0.05 to 0.3. The frictional engagement between the wavy wire segment and the vaso-occlusive coil may be such as to require a force of at least about 0.1 lbs to disengage.
In one general embodiment, the wire is designed for use with a catheter having a distal end one-way valve that permits the coil to be advanced in an inside-to-outside direction only. The coil is released by retracting the wire into the catheter once the coil has been expelled from the catheter end.
In another general embodiment, the delivery device further includes an outer sleeve through which the wire in the device can be axially moved by manipulating the proximal wire end. The sleeve has a distal end adapted to engage the coil, as the wire is retracted into the sleeve, to dislodge the coil from the wire.
Also disclosed is a method for releasably engaging a vaso-occlusion coil of the type having an end-region inner lumen. The method involves the steps of immobilizing the coil in a substantially linear condition in a tube having an open access end and inserting into the tube a wire device of the type described above.
REFERENCES:
patent: 3834394 (1974-09-01), Hunter et al.
patent: 3868956 (1975-03-01), Alfidi et al.
patent: 5007914 (1991-04-01), Sepetka
patent: 5109867 (1992-05-01), Twyford, Jr.
patent: 5122136 (1992-06-01), Guglielmi et al.
patent: 5217484 (1993-06-01), Marks
patent: 5234437 (1993-08-01), Sepetka
patent: 5250071 (1993-10-01), Palermo
patent: 5261916 (1993-11-01), Engelson
patent: 5263964 (1993-11-01), Purdy
patent: 5304195 (1994-04-01), Twyford, Jr. et al.
patent: 5312415 (1994-05-01), Palermo
patent: 5350397 (1994-09-01), Palermo et al.
patent: 5354295 (1994-10-01), Guglielmi et al.
patent: 5423829 (1995-06-01), Pham et al.
patent: 5445646 (1995-08-01), Euteneuer et al.
patent: 5522836 (1996-06-01), Palermo
patent: 5540680 (1996-07-01), Guglielmi et al.
patent: 5545169 (1996-08-01), Varger
patent: 5562698 (1996-10-01), Parker
patent: 5578074 (1996-11-01), Mirigian
patent: 5624449 (1997-04-01), Pham et al.
patent: 5989242 (1999-11-01), Saadat et al.
patent: 0 717 969 A2 (1996-06-01), None
patent: 0 717 961 A1 (1996-06-01), None
patent: 2 696 636 (1994-04-01), None
patent: 2 712 797 (1996-03-01), None
patent: WO 93/21830 (1993-11-01), None
patent: WO 94/06502 (1994-03-01), None
Anderson et al., “Transcatheter Intravascular Coil Occlusion of Experimental Arteriovenous Fistulas” (1977).
BALT Extrusion (France), “Mechanical Detachment System for SPIRALE,” Sales Brochure (1993).
Bourang Henry
Chee Uriel Hiram
Nguyen Kim
Hirsch Paul J.
Morrison & Foerster / LLP
Target Therapeutics Inc.
LandOfFree
Vaso-occlusion apparatus having a manipulable mechanical... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Vaso-occlusion apparatus having a manipulable mechanical..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Vaso-occlusion apparatus having a manipulable mechanical... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2455354