Surgical basket devices

Surgery – Instruments – Means for concretion removal

Reexamination Certificate

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Details

C606S127000, C606S001000

Reexamination Certificate

active

06264664

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates broadly to medical instruments. More particularly, this invention relates to basket devices for retrieving calculi located in the urological and gastrointestinal ducts. This invention can also be used to retrieve foreign objects from various locations within the mammalian body.
2. State of the Art
Surgical basket instruments are inserted into endoscopes and are typically used to remove calculi in the form of kidney stones, gallstones, biliary stones, and the like from the body without requiring a large incision. The basket instruments generally include a shaft having a resilient basket assembly coupled (for example, via crimping, welding, or soldering) to the distal end thereof, and a sheath (catheter) through which the shaft is axially extendable. The basket assembly is generally formed from resilient strands defining a cage-like enclosure. The basket assembly is radially collapsible to fit within the sheath, but distal movement of the shaft relative to the sheath enables the basket assembly to be moved beyond the distal end of the sheath. A wire, cable, or other mechanism, coupled proximally to the shaft at a handle and distally to the basket, is used to manipulate and expand and contract the extended basket. When the basket is in an expanded state, the basket may be maneuvered to envelop a calculus. The shaft may then be moved relative to the sheath to collapse the basket around the calculus and secure the calculus therein. The entire instrument is then withdrawn from the body of the patient along with the calculus. In addition, baskets may be expanded within a vein and rotated to function as a filter or thrombectomy device.
Several different basket designs are known in the art. For example, U.S. Pat. No. 5,064,428 to Cope et al., U.S. Pat. No. 4,611,594 to Grayhack et al., and U.S. Pat. Nos. 5,496,330 and 5,788,710 both to Bates et al. disclose prior art basket assemblies, and are hereby incorporated by reference herein in their entireties. U.S. Pat. No. 5,176,688 to Narayan et al., discloses an endoscopic basket instrument for use with a multi-bore endoscope having a first bore provided for operating a basket assembly, a second bore provided for a hammer, and a third bore for an optical system, and is hereby incorporated by reference herein in its entirety. U.S. Pat. No. 5,057,114 to Wittich et al. discloses an endoscopic basket instrument having a basket formed from superelastic metallic alloy wires, and is hereby incorporated by reference herein in its entirety.
However, the medical community has not been satisfied with the currently available basket instruments. In particular, with the instruments of the prior art, it is relatively difficult to visualize the surroundings at the distal end of the basket assembly especially when the basket contains a large calculus, adequately steer the instrument through the tortuous urological or gastrointestinal tracts, and adequately surround and capture a large calculus. One reason is the inability of the physician to fluoroscopically visually monitor the distal end of the basket assembly during the procedure such that the physician can best steer the basket assembly and attempt calculus entrapping. Further, the instruments of the prior art require that relatively complex mechanisms be built within the basket device to crush the calculi into smaller particles once captured or to obliterate the calculi altogether.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a basket instrument having a basket assembly which facilitates positioning the instrument to more adequately entrap calculi in the basket assembly for removal from the urological and gastrointestinal systems.
It is a further object of the invention to provide a basket instrument providing a pathway which can accommodate a laser which destroys objects within the basket.
It is another object of the invention to provide a basket instrument providing a channel for an optical device to allow the physician to better visualize, steer, and monitor the movement of the basket and locate the calculi to facilitate entrapment.
A further object of the invention is to provide a basket instrument having a laser extending beyond a distal end of the instrument which can be used as a sphinctertome.
Another object ofithe invention to provide a basket instrument which provides the ability to both view the surroundings at a distal end of the instrument and operate a laser which destroys objects within the basket.
In accord with these objects, which will be discussed in detail below, the surgical basket instrument of the invention generally includes a sheath (catheter), a hollow shaft extending through and axially movable relative to the sheath, a basket assembly coupled to a distal end of the shaft, and an activation handle coupled to a proximal end of the shaft and adapted for facilitating movement of the shaft relative to the sheath such that the basket assembly may be moved out of and into the distal end of the sheath. The basket assembly is formed from a plurality (e.g. three or more) of circumferentially spaced flexible wires or cables which facilitate entrapping of urological and gastrointestinal calculi. It is preferred that the hollow shaft be constructed from a compacted cable formed from a plurality of wires or cables which have been first twisted about a core and then drawn through at least one die (i.e. compacted) as is disclosed in greater detail (Docket # AVE-039) and U.S. Ser. No. 09/476,195 both to Avellanet, which are hereby incorporated by reference herein in their entireties. More particularly, a channel is formed within the shaft by removing the core after the wires or cables forming the exterior of the shaft have been compacted. Preferably, the channel extends axially through the center of the entire shaft, and the shaft extends from the proximal end of the instrument to the proximal end of the basket assembly. However, the shaft may be adapted to extend to or beyond the distal end of the basket assembly. It is preferable that the shaft be formed from a flexible yet strong material such as a nickel-titanium alloy.
According to a first embodiment of the invention, a fiber optic is attached within the channel in the shaft and extends to the proximal end of the basket assembly. The fiber optic is adapted to carry a laser beam for destroying calculi contained within the basket assembly. The channel of the shaft is substantially enclosed at the distal end of the shaft. The channel is substantially enclosed at the distal end of the shaft by a shield which substantially surrounds but does not block a tip of the fiber optic.
According to a second embodiment, the fiber optic is axially movable within the shaft, and may extend into the basket assembly and beyond the distal end of the instrument.
According to a third embodiment of the invention, at least a pair of fiber optics extend within the channel in the shaft to the distal end of the shaft. One of the pair of the fiber optics is used to send light down the shaft. The other of the pair may be used to visualize the calculi and the surroundings. Either of the pair may also be adapted to receive a laser for destroying calculi contained within the basket. Alternatively, a third fiber optic is adapted to receive the laser. Additionally, a proximal source of fluid useful in cleaning the visualization optic is coupled to and in fluid communication with the channel of the shaft.
According to a fourth embodiment, a shaft having a channel is extended through the basket assembly and beyond the distal end of the instrument. A fiber optic, adapted to receive a laser, is attached within the channel and extends beyond to the distal end of the shaft. The laser operates as a sphinctertome, to cut a pathway into a bile duct or other sphincter enabling insertion of the basket assembly into the duct.
Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description t

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