Catheter with protective sleeve

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S171000

Reexamination Certificate

active

06830561

ABSTRACT:

FIELD OF THE INVENTION
The field of the invention relates to devices and methods for accessing the spinal canal and structures of the brain. Specifically, the invention relates to a catheter device and methods of use for traversing the vasculature or spinal canal of a patient to access distal regions of the spinal canal and the brain.
BACKGROUND OF THE INVENTION
In extant neurointerventional procedures, there are essentially two-methods to access the brain and intracranial structures: Open (Craniotomy) and Minimally Invasive (Endovascular or Endolumenal). The open approach is surgical through a craniotomy (perforation). This is an invasive procedure.
A second approach uses minimally invasive endovascular or endolumenal techniques to access the vasculature or structures of the brain. In this procedure, a catheter or similar device is inserted, tracking its way through an artery or other navigable lumen into the anatomical treatment site. Depending on the nature and scope of the disease and the overall health of the patient, this navigation and placement of the access and delivery device and therapeutic modality can be very challenging. The opportunity for prolonged procedures and iatrogenic episodes is real as a lumen or canal may be congenitally, pathologically or traumatically compromised and tortuous. Most procedures require the serial introduction and reintroduction of a number of devices to complete an optimal medical intervention. Tissues within the patient are subjected to repetitive contact with access, delivery and therapeutic devices, including the insults of tissue dissection, resection and friction. Transient, permanent, catastrophic and fatal injury may occur.
Accordingly, there is a need for a device and method that is capable of introducing a catheter or similar device into the spinal canal that minimizes or eliminates the risk of patient injury. The device and method would permit a physician to access regions of the spinal canal and brain that were heretofore impossible or difficult to reach using convention endovascular or endolumenal techniques.
SUMMARY OF THE INVENTION
In a first aspect of the invention, a device for accessing the spinal canal of a patient includes an introducer, a protective sleeve, and a catheter. The protective sleeve has one end thereof attached to the distal end of the introducer, the sleeve having an outer stationary portion and an inner moveable portion. A catheter is disposed within the protective sleeve adjacent to the moveable portion.
In another aspect of the invention, an advancement mechanism is provided for advancing the protective sleeve within the spinal canal at a rate that is at least twice the rate of advancement of the catheter.
In another aspect of the invention, a device for accessing the spinal canal of a patient includes an introducer, a protective sleeve, and a catheter. The protective sleeve has one thereof attached to the distal end of the introducer. The protective sleeve projects distally from the introducer and includes a moveable crown region at the distal end of the protective sleeve. A catheter is disposed within the protective sleeve.
In still another aspect of the invention, a method of traversing the spinal canal with a catheter includes the steps of deploying a protective sleeve within a portion of the spinal canal and advancing a catheter within the protective sleeve through the portion of the spinal canal.
It is an object of the invention to provide a device having a protective sleeve that forms a stationary barrier between a patient's spinal cord and a moveable catheter. It is another object of the invention to provide a catheter device that can reach the vasculature of brain through the ventrical and the subarachnoid space using the spinal canal as an access route. It is another object of the invention to provide a method of efficiently and safely traversing the spinal canal with a catheter.


REFERENCES:
patent: 3867937 (1975-02-01), Schwartz
patent: 4573981 (1986-03-01), McFarlane
patent: 5370623 (1994-12-01), Kreamer
patent: 5586968 (1996-12-01), Grundl et al.
patent: 5662703 (1997-09-01), Yurek et al.
patent: 5730754 (1998-03-01), Obenchain
patent: 6059813 (2000-05-01), Vrba et al.
U.S. patent application Ser. No. 2001/0044595 A1, Reydel, et al “Introducer Apparatus with Eversible Sleeve”, publication date Nov. 22, 2001.
U.S. patent application Ser. No. 2003/0105508 A1, Johnson, et al “Everting Balloon Stent Delivery System Having Tapered Leading Edge”, publication date Jun. 5, 2003.

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