Surgery – Instruments – Electrical application
Reexamination Certificate
2001-05-07
2003-04-29
Walberg, Teresa (Department: 3742)
Surgery
Instruments
Electrical application
C600S562000
Reexamination Certificate
active
06554828
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the field of surgical instruments, e.g., laparoscopic instruments. More specifically, the present invention relates to a reusable hand held laparoscopic surgical instrument having improved flushing and cleaning/sterilization capabilities.
BACKGROUND OF THE INVENTION
The use of surgical instruments such as laparoscopic instruments during surgical procedures is known. One important consideration during such procedures is the protection of patients and healthcare personnel from disease transmission. Recently, the prevention of disease transmission has become even more important as emerging antibiotic resistant microorganisms have become more prevalent.
One significant problem with the use of surgical instruments is the removal of the bio-burden and/or microorganisms that build up inside the chamber of the instrument. During surgical procedures, the distal end of the lumen comes in contact with bio-burden such as blood, fat, protein, carbohydrates and starches. In particular, the positive pressure of the insufflated abdomen forces blood and other body fluids into the instrument and is difficult or impossible to remove. After the procedure, reusable instruments have to be cleaned and sterilized prior to use on the next patient. These instruments are extremely difficult to clean because of the long shaft and “dead spaces” within the lumen that trap bio-burden. Instruments that cannot be flushed and cleaned properly cannot be sterilized or disinfected with 100% certainty. Previous designs for such surgical instruments include a lumen that can promote the build-up of bioburden and microorganisms in the “dead spaces” and corners of the lumen, even when cleaned by highly skilled hospital personnel trained in instrument cleaning protocols.
One solution to this problem has been the development and use of single-use disposable instruments. While the use of a disposable instrument ensures the lack of bio-burden in the instrument, the cost is quite high because the instrument is disposed of after just one surgical procedure. In addition, disposable instruments are made of a lower quality material and lack the tactile feel, stability or strength of a reusable instrument. Another attempt at solving the problem has been the development of “modular” instruments that are disassembled and manually cleaned and scrubbed after each surgical procedure. Yet, these modular instruments are time-consuming and difficult to clean due to the “dead spaces” and the hard to clean corners inside the lumen.
A further approach to the removal of bio-burden and microorganisms in a laparoscopic instrument includes the use of a reusable instrument that has a flush port useful to clean the instrument. The flush port allows a cleaning solution to be flushed through the lumen of the instrument. However, this approach may not completely remove all of the bio-burden and microorganisms inside the lumen of the instrument. In particular, previous designs have included a lumen with corners that become partially occluded with a build-up of bio-burden over time.
Accordingly, there exists a need for a reusable surgical instrument with an internal chamber that allows for the efficient removal of bio-burden and microorganisms combined with maximum bacteria kill rates during steam sterilization.
SUMMARY OF THE INVENTION
The present invention is directed to a reusable surgical instrument with an improved lumen and “Clear Flush” chamber that eliminates corners and edges which collect bio-burden and microorganisms. The present invention also reduces the possibility of such a build-up within the lumen or passageway of the instrument by providing an improved flushing and cleaning/sterilization capability.
According to a first aspect of the invention, a surgical instrument having a handle and an elongated member is provided. The elongated member has a proximal end and a distal end. The elongated member defines an interior passageway having a narrowed throat portion adjacent the distal end. The throat portion has a substantially smooth and cornerless continuous surface. A movable rod is located within the passageway of the elongated member and passes through the throat portion of the elongated member. A tool is connected to the rod and extends from the distal end of the elongated member.
According to a second aspect of the invention, a medical device that is insertable into a body is provided. The medical device includes a handle and an elongated member. The elongated member is connected to the handle and includes a proximal end and a distal end. The elongated member includes an interior lumen having a narrowed throat portion adjacent the distal end. A movable rod is located within the lumen of the elongated member and passes through the throat portion of the lumen. The throat portion is at least partially and substantially spaced away from the rod in order to provide for a relatively unencumbered flow of fluid therethrough. A tool is connected to the rod and extends from the distal end of the lumen. A port is connected to the passageway of the lumen and is adapted to receive a cleaning solution for insertion through the passageway and out the distal end of the lumen.
According to a further aspect of the invention, a laparoscopic medical device that is insertable into a body is provided. The medical device includes a handle and an elongated member. The elongated member is connected to the handle. The elongated member has a proximal end and a distal end and includes an interior passageway having a narrowed throat portion adjacent the distal end. The throat portion has a substantially smooth and cornerless continuous surface. A movable rod is located within the passageway of the elongated member and passes through the throat portion of the elongated member. The throat portion is at least partially and substantially spaced away from the rod. A tool is connected to the operating rod and extends from the distal end of the elongated member. A port is connected to the passageway of the elongated member and is adapted to receive a cleaning solution for insertion through the passageway.
The present invention, together with attendant objects and advantages, will be best understood with reference to the detailed description below in connection with the attached drawings.
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