Surgery – Instruments – Blood vessel – duct or teat cutter – scrapper or abrader
Reexamination Certificate
2001-04-04
2004-11-16
Bennett, Henry P. (Department: 3743)
Surgery
Instruments
Blood vessel, duct or teat cutter, scrapper or abrader
C606S167000, C606S170000, C606S171000, C606S180000
Reexamination Certificate
active
06818001
ABSTRACT:
BACKGROUND OF INVENTION
The present invention relates to systems and methods for removing material, such as obstructions and partial obstructions, from any body lumen of a mammalian subject, such as a blood vessel, a portion of the gastrointestinal tract, a portion of the dural spaces associated with the spinal cord, or the like. More particularly, the present invention relates to systems, system components, and methods for removing material from a lumen of a mammalian subject using an advanceable, rotating cutter assembly.
DESCRIPTION OF PRIOR ART
Removal of atherosclerotic obstructions and partial obstructions using rotating cutter assemblies is a well-established therapeutic intervention. Numerous atherectomy methods and devices have been conceived and developed. Most of these systems involve placement of a guide wire, a guiding catheter and a cutting device in proximity to an obstruction or partial obstruction in a blood vessel and then advancing and rotating the cutting device to cut or ablate the obstruction.
The following U.S. patents describe many types and specific features of atherectomy devices: U.S. Pat. Nos. 4,898,575; 5,127,902; 5,409,454; 5,976,165; 5,938,670; 5,843,103; 5,792,157; 5,667,490; 5,419,774; 5,417,713; 4,646,736; 4,990,134; 4,445,509; 5,681,336; 5,695,507; 5,827,229; 5,938,645; 5,957,941; 5,019,088; 4,887,613; 4,895,166; 5,314,407; 5,584,843; 4,966,604; 5,026,384; 5,019,089; 5,062,648; 5,101,682; 5,112,345; 5,192,291; 5,224,945; 4,732,154; 4,819,634; 4,883,458; 4,886,490; 4,894,051; 4,979,939; 5,002,553; 5,007,896; 5,024,651; 5,041,082; 5,135,531; 5,192,268; 5,306,244; 5,443,443; 5,334,211; 5,217,474; 6,183,487; 5,766,190, 5,957,941 and 6,146,395. These U.S. patents are incorporated by reference herein in their entireties.
Despite the many and varied approaches to atherectomy systems and methods exemplified by the U.S. patents cited above, many challenges remain in providing systems and methods for removing material from a lumen, such as a blood vessel, safely and reliably and without causing complications. The safety and reliability of the system is manifestly critical. Recovery of the debris generated during an atherectomy operation, or maceration of the debris to a particle size that will not produce additional blood vessel clogging or damage, is essential. The flexibility and size of the system is also an important feature. Control features and the ease of use of the system by a surgeon or other medical professional are additional important features.
One of the particular challenges of removing material from the interior of lumens is that the drive and cutter assemblies must be small enough and flexible enough to travel, over a guidewire, to a desired material removal site, such as the site of an obstruction or occlusion. Yet, the drive and cutter assemblies must be large enough and have structural integrity sufficient to operate reliably and effectively to cut or ablate the obstruction. Additionally, removal of the debris from the material removal site using an aspiration system is generally desirable. The drive and cutter assemblies therefore desirably incorporate a debris removal system as well.
The size and consistency of the material comprising the obstruction are frequently not well characterized prior to introduction of the material removal device. Thus, although devices and cutters having different sizes and properties may be provided, and may even be interchangeable on a materials removal system, it is difficult to ascertain which combination of features is desired in any particular operation prior to insertion of the device. The use of multiple cutter assemblies having different properties during a materials removal operation is inconvenient at best, since it requires removal of each independent device and interchange of the cutter assemblies, followed by reinsertion of the new cutter assembly, or of a new device entirely. Interchange and reinsertion of cutter assemblies is time consuming and generally deleterious to the health and condition of the patient undergoing the procedure.
Many different types of expandable cutters have been conceived in an effort to provide a cutter having a small diameter profile that may be delivered to and removed from the site of the desired material removal, and that is expandable at the site to provide a larger diameter cutter. The following U.S. patents disclose various approaches to expandable cutter assemblies: U.S. Pat. Nos. 5,540,707; 5,192,291; 5,224,945; 5,766,192; 5,158,564; 4,895,560; 5,308,354; 5,030,201; 5,217,474; 5,100,425; and 4,966,604. These patents are incorporated by reference herein in their entireties.
Although many approaches to expandable cutter assemblies have been developed, none of these approaches has, to date, been known to be implemented in a commercially successful atherectomy system.
SUMMARY OF INVENTION
One aspect of the present invention involves the therapeutic application of methods and systems for translumenal microsurgery using advanceable, rotating cutter assemblies to conditions and disorders in addition to atherectomy and cardiology applications. Methods and systems for translumenal microsurgery using advanceable, rotating cutter assemblies of the present invention may be implemented, for example, in treatment of blood vessel conditions and for removal of accumulations of materials in blood vessels in applications other than cardiology and in blood vessels remote from the heart; in treatment of benign prostate hyperplasia; in the treatment of gynecological conditions involving accumulation of material in fallopian tubes and elsewhere, such as fibrotic disease; in treatment of urological conditions, such as kidney stones; in treatment of gallbladder conditions, such as gall stones; and in the treatment of spinal cord and dural tube conditions, such as stenoses of the spinal canal.
Methods and systems of the present invention involve placement of a material removal component, referred to herein as a “cutter” or “cutter assembly” within a lumen of a mammalian subject using conventional techniques, such as guidewires and guiding catheters. The intralumenal material removal system includes a cutter assembly positionable in the lumen of a mammalian subject and operably connected to system controls, mechanical and power systems by means of a rotating drive shaft and generally, a stationary guide catheter. The cutter assembly preferably comprises a distal cutting or abrading head having one or more cutting and/or abrading surfaces that is advanceable by translating the drive shaft and rotatable by rotating the drive shaft. The cutter assembly may comprise two or more cutters having different properties.
According to a preferred embodiment of the present invention, the cutter assembly comprises a cutter that is adjustable between a smaller diameter condition, in which it may be guided to and withdrawn from the desired material removal site, and a larger diameter condition, in which it may be operated during a material removal operation. The cutter may thus be introduced to and withdrawn from the material removal site in a retracted, smaller diameter condition that facilitates translation and navigation of the device through various lumens, such as blood vessels. The expandable cutter may be selectively expanded at the material removal site to facilitate cutting, removal and aspiration of the material desired to be removed.
The material removal system preferably provides removal of debris, generally via aspiration through one or more material removal ports in the cutter assembly or another component in proximity to the cutter assembly. Debris generated during a material removal operation is removed by aspiration through the material removal ports and withdrawn through a sealed lumen formed, for example, between the cutter assembly drive shaft and a catheter. The sealed lumen is connectable to a vacuum source and aspirate collection system.
According to another preferred embodiment, the materials removal device of the present invention comprises dual cutting and/or abrading m
Auth David C.
Clement Thomas J.
Lawson Craig E.
Wulfman Edward I.
Benado Lisa N.
Bennett Henry P.
Odland Kathryn
Pathway Medical Technologies, Inc.
Sleath Janet
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