Surgery – Means for introducing or removing material from body for... – With means for cutting – scarifying – or vibrating tissue
Reexamination Certificate
1999-04-14
2002-08-06
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
With means for cutting, scarifying, or vibrating tissue
C604S543000, C606S171000
Reexamination Certificate
active
06428498
ABSTRACT:
TECHNICAL FIELD
This invention relates generally to medical devices, and more particularly to a device for debriding, aspirating, and draining an abscess present in a human or veterinary patient.
BACKGROUND OF THE INVENTION
A variety of locations within the body of a human or veterinary patient are subject to developing an abscess after the occurrence of infection or contamination at such locations. Contamination can result from structural changes or damage to tissues in the body caused by injury or surgery, or can result from structural irregularities arising naturally within the body. Abscesses often develop in an existing tract or passage within the body, such as in mucus glands, for example, rectal mucus glands. An abscess can perhaps most simply be considered as a sac containing bacteria, body fluids and sera, blood clots, dead or necrotic tissue, and the like. Treatment of an abscess entails debriding the abscess and draining it of such materials contained in it.
A variety of suction and other devices are known for cutting and removing a wide range of materials from the body at locations other than abscesses. Such devices usually possess a structure which is particularly adapted to the location of interest, and which is particularly adapted to the material to be removed. Unfortunately, such devices are ill-suited to the particular problems encountered when draining and debriding abscesses. More particularly, such devices are generally rigid and are therefore not suited for introduction into and through an existing tract or passage in which an abscess has formed.
For example, U.S. Pat. No. 4,660,267 (C. R. Wheeler, Apr. 28, 1987) discloses a method of fabricating a surgical probe for performing arthroscopic surgery. The probe resulting from the method includes an outer tube and an inner tube which rotates at relatively high speeds within the outer tube. A bearing is formed by an inwardly extending bearing surface on the distal end of the outer tube and a complementary bearing surface on the distal end of the inner tube. Each of the outer and inner tubes has aligned openings on one side near their distal ends, such that the high speed rotation of the inner tube within the outer tube shaves tissue entering the side openings. Suction is applied to the inner tube to draw the shaved tissue away from the distal end of the probe to avoid clogging of the openings. The bearing provides both radial and longitudinal thrust bearing support to the device during rotation of the inner tube.
U.S. Pat. No. 5,295,980 (R. A. Ersek, Mar. 22, 1994) is directed to an infusion and aspiration catheter useful, for example, during liposuction or a biopsy, which includes a cannula member having a rounded, partially open, blunt insertion tip, and a stilette (sic., presumably a stylet) which is received in the cannula member. The stilette can be rotated or moved longitudinally in the cannula member to cut, saw or grasp a tissue specimen. The patent notes at column 5, lines 5 through 10, that it is important that the opening of the cannula member be located on a taper between the blunt end of the member and the cylindrical shaft portion of the member, but that the opening encompass neither the distal end nor any portion of the shaft of the member.
U.S. Pat. No. 5,290,303 (E. D. Pingleton, Mar. 1, 1994) discloses a surgical cutting instrument for laparoscopic or endoscopic use which includes an inner rotary tube member having a cutting edge at its distal end which extends from a stationary sheath which prevents tissue from wrapping around the rotary tube member. The inner cutting member tube includes a hollow passageway for suctioning and aspirating tissue and fluid, and the instrument further includes an outer safety shield having a rounded distal end for preventing puncture of a surgical tissue bag, or for preventing the unintentional cutting of tissue. An access channel for accepting tissue is located laterally about the distal end of the safety tube, and acts as a jaw which feeds tissue into a rotary cutting edge extending circumferentially about the distal end of the inner member.
Finally, U.S. Pat. No. 4,655,743 (L. L. Hyde, Apr. 7, 1987) is directed to an irrigation-aspiration device useful in eye surgery and which includes an outer cannula and an inner cannula which can be reciprocated within the outer cannula. Tissue is drawn into the device through a lateral suction port located proximal to the distal tip of the inner cannula, and is cut between the suction port and the distal tip of the outer cannula. The inner cannula is bent along its length and is springy so that the port abrades against the end of the outer cannula with a biting or cutting action. An inner lumen of the inner cannula is connected to vacuum or a suction source to draw fragments of the eye into the port for cutting.
While these devices appear to be useful for their individual and particularly intended purposes, it would appear that none of these devices is particularly adapted for debriding and draining an abscess, phlegmon, or hematoma, and that none of these devices is capable of performing not only their individual and particularly intended purposes, but also the additional functions of a conventional drainage catheter. In particular, substantially all of these devices include a rigid first cutting cannula inside a rigid second cutting cannula. Such devices are not intended to be left in a patient to allow drainage of a site of interest, for example, an abscess, after performing one surgical technique or another.
It would be highly desirable to have a debriding device which was particularly adapted for debriding and draining an abscess or phlegmon in a human or veterinary patient, and which was structured to meet the particular problems encountered in debriding and draining an abscess. It would also be highly advantageous to have such a device which was sufficiently flexible to allow it to be introduced into and through any existing tract in which an abscess has developed. It would further be advantageous to have such a device in which it is primarily the cutting cannula which shears any tissue or other material to be debrided, in contrast to the more rigid prior devices in which the stiffness of an outer cannula contributes substantially to the shearing of such tissue or other material. It would be still further advantageous to have such a device which was capable of cutting blood clots and dead or necrotic tissues in or adjacent to the abscess, and which was capable of removing, by suction, any materials so cut. Finally, it would also be highly desirable to have such a device which could be left in a patient for some time after the performance of a surgical technique, for draining the site at which the technique was performed.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved in an illustrative medical device particularly adapted for debriding and draining abscesses present in a human or veterinary patient. The device of the present invention is directed to a specific combination which either comprises or consists of a catheter having a lateral opening, and a cutting needle or cannula (hereinafter, “cutting cannula”) received in the catheter and having a circumferential cutting edge which can be slid along the lateral opening of the catheter. Longitudinal movement of the cutting cannula in the catheter causes the circumferential cutting edge to sever any material which extends through the lateral opening. Suction is applied to the proximal end of the cutting cannula to draw material from the abscess through the lateral opening of the catheter, through the cutting cannula and out of the device. The catheter is preferably flexible and is adapted to allow drainage of the abscess even when the cutting cannula is not positioned in the catheter.
This specific cutting structure is quite different from the prior devices mentioned above, which have been employed for decidedly different purposes. First, the prior devices mentioned above generally include a first rigid cutting cannula
Casler Brian L.
Hodgson & Russ LLP
Thanh Lohn H.
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