Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-07-08
2001-08-28
Yasko, John D. (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S041000, C604S096010, C604S286000
Reexamination Certificate
active
06280413
ABSTRACT:
FIELD OF THE INVENTION
A thrombolytic filtration and drug delivery catheter, and more particularly, a thrombolytic filtration and drug delivery catheter comprising longitudinal ribs which are advanced to the desired site in a compressed position and can be released to a deployed position at the desired site.
BACKGROUND OF THE INVENTION
Catheters serve a variety of functions in medical procedures. In addition to the dilatation of clogged arteries, catheters are used to deliver drugs or other agents to sites in the cardiovascular system, the urethra, bladder, prostate, rectum and central nervous system, such as along the spinal column. Other applications include the delivery and placement of devices, such as a thrombolytic filter.
A variety of thrombolytic filters are available. When positioned, the filters, which are typically in the shape of an umbrella or mesh, expand across the blood vessel. Access to a desired site is often percutaneous, however. The catheter must also often be advanced through narrow vessels or lumens with tortuous turns. A narrow catheter is thus preferred for ease of insertion and advancement. Thrombolytic filters must therefore be capable of being delivered through a narrow catheter shaft.
Such filters typically comprise wires of stainless steel in the desired configuration, compressed for delivery through a catheter. When released from the catheter, they expand across the blood vessel. Shape memory alloys have also been used to form expandable devices which can be delivered in a compressed state and are activated by temperature, for example. The filter can be expanded by a balloon, as well. Some devices include hooks to engage the vessel wall, securing the filter in position. Since thrombosis is most common in the lower extremities, such devices are usually implanted in the inferior vena cava to prevent thrombolytic material from entering the heart, where it could be pumped to the lungs, causing a life threatening pulmonary embolism. Thrombolytic material can also cause a cerebral embolism or myocardial infarction.
Use of metal alloys and wires, however, particularly those with hooks, can damage the tissue of the lumen or vessel, causing thrombosis. The filters may also be difficult to place and remove, particularly when filled with thrombolytic material. Some devices occlude too much of the blood vessel, preventing adequate blood flow. The use of such devices often requires the oral administration of anticoagulants, as well.
A commercially available thrombolytic filtration product, the Prolyser™ from Cordis®, comprises an outer catheter shaft of fluoropolymeric material with longitudinal ribs. An inner catheter shaft runs axially through the outer shaft. The inner shaft is attached to the distal end of the outer shaft, and can be retracted. Retraction of the inner shaft brings the ends of the longitudinal ribs closer together, causing the longitudinal ribs to flare outward toward the walls of a vein. Thrombolytic material flowing through a vein can be caught by and trapped within the flared longitudinal ribs. The inner shaft includes ports for the delivery of lytic agents within the region encompassed by the ribs. The lytic agent may be too dissipated when it reaches the ribs, however, to adequately dissolve thrombolytic material caught between the ribs.
SUMMARY OF THE INVENTION
In accordance with the present invention, a catheter is disclosed which delivers drugs or other agents through a self-expanding filtration portion of the catheter.
In one embodiment of the invention, the catheter comprises a shaft with a proximal and distal portion, the distal portion comprising filtration means which in a first position flares beyond the diameter of the shaft. A means for compressing the filtration means is provided such that when the means for compressing is released from the filtration means, the filtration means flares to its first position. A means for delivering drugs or other agents to the filtration means is also provided. The filtration means is adapted to bear against the walls of a lumen, such as a vein or artery, when released. The filtration means preferably comprises polymeric material.
In accordance with another aspect of the invention, a catheter is disclosed comprising a shaft with a proximal and distal portion, the distal portion comprising a plurality of longitudinal ribs which in a first position flare beyond the diameter of the shaft. The shaft further comprises delivery lumens extending longitudinally through the shaft and ribs and at least one port in each rib for a delivered drug or agent to exit the rib. A sleeve receives at least the distal portion of the shaft. The sleeve and shaft can move with respect to each other such that when the member is retracted from the distal portion, the longitudinal ribs are in their first position and when the distal portion is within the member, the member compresses the ribs into a second position. A plurality of ports are preferably provided around the ribs. The longitudinal ribs are preferably adapted to bear against the walls of a lumen, such as a vein or artery, when released. The longitudinal ribs also preferably comprise polymeric material.
A catheter is also disclosed in accordance with the present invention wherein the longitudinal ribs are compressed by a thread. When the thread is released from the longitudinal ribs, the ribs flare into their first position.
A filtration device is also disclosed in accordance with the present invention, comprising a self-expandable polymeric filter, means for compressing the filter, at least one delivery lumen providing drugs or other agents to the filter and at least one port in the filter in fluid communication with the delivery lumen.
A catheter is also disclosed, wherein the longitudinal ribs are solid.
A method of delivering drugs or other agents within a lumen by a catheter is also disclosed comprising advancing a catheter with compressed, expandable longitudinal ribs to a desired site within the lumen, releasing the compressed longitudinal ribs to allow the longitudinal ribs to flare beyond the diameter of the shaft, and delivering drugs or other agents through the longitudinal ribs. Different drugs or other agents may be delivered through different longitudinal ribs.
A method of filtering thrombolytic material from a vessel within the cardiovascular system is also disclosed comprising advancing a catheter to a desired site within the vessel, and retracting a portion of the catheter to allow a plurality of compressed longitudinal ribs in the distal portion of the catheter to flare beyond the diameter of the catheter to contact the vessel, and delivering a drug or other agent, such as a lytic agent, through the ribs. Different drugs or other agents may be delivered through different longitudinal ribs.
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Chornenky Victor I.
Clark David W.
Clark Souise S.
Forman Michael R.
Lee Jeffrey A.
Medtronic Ave Inc.
Yasko John D.
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