Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2000-11-02
2002-11-26
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S902000
Reexamination Certificate
active
06485452
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to medical irrigation systems and, more particularly, to hand-held medical irrigation devices that have a tip with suction and irrigation channels.
BACKGROUND OF THE INVENTION
Irrigation devices are in common use in a variety of non-surgical environments, such as nursing homes and other long-term care facilities, where they are used to treat bed sores and other injuries that are accessible externally about a patient. These devices generally comprise an irrigation handpiece and accompanying irrigation tip that direct irrigation liquid from an irrigation source to an irrigation site. Effective treatment often requires that the injured site be irrigated several times.
Conventional irrigation and suction devices have a combination suction and irrigation tip that can be detachably connected to a handpiece having both irrigation and suction lumens. The free end of the tip has a conical splash shield that, during use, is pressed against and about the irrigated region to confine irrigation liquid (e.g., saline) to that region. A typical tip is shown in U.S. Pat. No. 4,692,140 (Olson). The Olson tip has an outer (suction) tube, an inner (irrigation) tube coaxially aligned with the suction tube, and a web (referred to as “pegs” in Olson) that supports the distal end of the irrigation tube within the suction tube. The annular space between the tubes provides a suction pathway for biological debris aspirated from the irrigation site. Aspirated biological debris is drawn through the suction pathway to the suction lumen in the handpiece, from which it flows through a connecting tube to a debris collection chamber.
One problem with such devices is that the biological debris ingested into the handpiece suction lumen (from the irrigation site) may contain infectious bacteria that could contaminate the handpiece The handpiece can thus become septic and may create an undesirable risk of reinfection to the patient if it is reused. Accordingly, although irrigation handpieces with detachable tips are available, there has been a resistance to their use because the handpieces are relatively expensive and can only be used once. The preferred treatment is to to bathe the patient in a warm whirlpool bath instead of locally irrigating the injury with an irrigation handpiece and tip. This alternative treatment method is inefficient, however, since it is time consuming and treats both injured and uninjured parts of the patient's body.
Another difficulty with the foregoing coaxial tip is that the suction pathway can clog easily with aspirated biological debris because it has a relatively small cross-sectional dimension. The web also appears to further obstruct debris drawn toward the annular suction pathway since it partially covers the open distal end of the pathway.
A flexible splash shield that is permanently fastened to the distal end of the outer suction tube also presents problems. More particularly, when the irrigation tip must be positioned very close to the irrigation site, it may be necessary to cut off the end of the shield along one of several circumferential ring guides. In addition to being time consuming and cumbersome, the structure of the tip is permanently altered. A new tip must be used to irrigate a larger local injury site.
In addition, it is common during use for irrigation fluid and biological debris to escape from the splash shield because, for example, the irrigation surface may not be smooth or the attendant may inadvertently move the handpiece while irrigating. This can cause the debris and irrigation liquid to splash onto the handpiece and/or attendant, consequently contaminating the handpiece and exposing the attendant to infection.
It therefore is among the general objects of the invention to provide an improved suction/irrigation tip that avoids contamination of the handpiece.
SUMMARY OF THE INVENTION
In accordance with one aspect of the invention, the suction lumen in a detachable suction and irrigation tip is configured so that aspirated fluid and debris are passed directly to an external suction source when the tip is used with a conventional handpiece having both suction and irrigation lumens. No portion of the suction lumen in the tip is in fluid communication with the suction lumen in the handpiece. However, the irrigation lumen in the handpiece is in fluid communication with the irrigation lumen in the tip so that irrigation can pass through the handpiece and tip in normal fashion.
In accordance with another aspect of the invention, the suction and irrigation lumens in the tip are arranged coaxially with the inner tube defining the suction lumen and the annular lumen between the inner and outer tubes defining the irrigation lumen. The annular lumen terminates in an annular end wall that includes a number of circumferentially spaced outlet apertures through which irrigation liquid is emitted. Since the cross-sectional dimension of the suction lumen is greater than the radial dimension of the surrounding annular lumen, the risk of that lumen being clogged by debris is reduced.
In accordance with yet another aspect of the invention, a flexible splash shield is slidably mounted on the tip. This enables the distal end of the suction and irrigation tubes to be positioned directly against the irrigation site without having to cut the shield.
In accordance with still another aspect of the invention, the tip is provided with a protective covering having one end that is heat sealed to the tip and another end that is open. When the tip is connected to a handpiece, the covering is sized to fit loosely about the handpiece and may extend past the bottom of the handpiece. The covering protects the handpiece and the attendant from debris that may splash from the irrigation site.
It is among the objects of the invention to provide combination suction and irrigation tip that it detachably connectible to a handpiece and in which biological debris aspirated through the suction lumen bypasses the handpiece.
Another object of the invention is to provide an improved combination suction and irrigation tip that may be detachably connected to an irrigation handpiece in which the risk of the handpiece becoming contaminated with biological debris is reduced.
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Albrecht Stephen
Darois Roger
French Glen
Sakal Robert
Tremaine Laurence
C. R. Bard Inc.
Kennedy Sharon
Kirkpatrick & Lockhart LLP
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