Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-04-14
2001-12-18
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S191000
Reexamination Certificate
active
06331172
ABSTRACT:
TECHNICAL FIELD
The invention is a medical device which combines controlled dispensing of liquid or semiliquid substances with controlled suction. More specifically, the invention is a tissue adhesive applicator which selectively provides suction at the applicator tip during or immediately prior to adhesive application, or for clearing coagulated adhesive from the applicator tip.
BACKGROUND
Various known devices provide for the controlled dispensing of medical fluids. Furthermore, some are adapted to provide suction as well as irrigation at the dispensing tip. The suction is generally suitable for the removal of fluids during surgical procedures.
Examples of medical devices which are adapted to dispense fluid as well as provide vacuum at the working tip are disclosed in U.S. Pat. Nos.: 3,065,749; 3,469,582; 4,397,640; 4,573,979; 4,617,013; 4,696,669; 4,708,717; 4,776,840; 4,857,047; 5,061,180; and 5,226,877. Some of these devices have a suction pathway which is distinct from their dispensing pathway, such as those disclosed in U.S. Pat. Nos.: 3,065,749; 4,397,640; 4,573,979; 4,617,013; 4,696,669; 4,708,717; 4,857,047; 5,061,180; 5,226,877. Alternatively, some use the same pathway to either provide suction or dispense fluid, such as the devices disclosed in U.S. Pat. No. 3,469,582 and 4,776,840.
Referring to U.S. Pat. No. 4,776,840 to Freitas, a device is disclosed which has a suction outlet adjacent a dispensing outlet which may also provide suction in parallel to the suction outlet. In order to provide suction at the working tip, the user depresses a plunger which connects the vacuum source to the dispensing outlet pathway in addition to the suction pathway. In contrast, if the user desires to dispense fluid, the user pulls a trigger switch which is in communication with a piston. As the trigger is displaced, the piston is displaced and pushes fluid through a check valve leading to the dispensing outlet pathway.
In addition, devices adapted to dispense tissue adhesives or sealant are disclosed in U.S. Pat. Nos.: 4,040,420; 4,359,049; 4,735,616; 4,874,368; 4,978,336; 5,116,315; 5,226,877; 5,368,563; 5,474,540; and 5,605,541. Typically, these known devices have two self-contained fluid reservoirs. Each reservoir has an outlet passageway which may lead to a common passageway in which the fluids mix. In many tissue adhesive applications, a fibrinogen solution is mixed with a thrombin solution to start the clotting process and form the physiological adhesive or sealant. Often, the mixture that remains in the mixing passageway commonly causes clogging of the dispensing tip. To overcome this obstacle, some devices have been developed to spray the independent components of a two part biological adhesive so that mixing occurs in the spray between a device nozzle head and the tissue. Examples of such spraying devices are disclosed in U.S. Pat. Nos. 5,368,563 and 5,605,541.
Finally, disclosed suction and medical dispensing devices provide very limited volume indicators, such as visual volume indicators on the working device which require the user's attention to be diverted from the working area of fluid dispensing. An alternative volume indication mechanism is disclosed in U.S. Pat. No. 5,226,877 to Epstein. Epstein discloses a medical dispensing device that has an audible loudness indicator which provides discrete audible “clicks” at predetermined incremental volumes of fluid delivery. However, this beneficial indicator does not audibly indicate the cumulative volume of fluid dispensed, but instead requires a user to remember the number of clicks.
There is still a need for an audible loudness indicator which emits audible signals to a user that indicate the cumulative volume of fluid dispensed at each incremental volume of fluid delivery.
There is also still a need for an apparatus and method for withdrawing a cast of cured tissue adhesive or other congealing fluid from the dispensing conduit in the tip of a medical fluid applicator.
SUMMARY OF THE INVENTION
The present invention is a medical fluid applicator assembly which includes a dispensing assembly in combination with a suction assembly.
In one aspect of the invention, a dispensing assembly includes an audible loudness indicator which signals the cumulative volume of fluid dispensed by changing the pitch or loudness of an audible tone produced at predetermined volumetric increments.
In one variation of this fluid dispensing assembly, the audible loudness indicator includes a rack and pawl assembly which has a plurality of teeth with variably positioned regions on the rack. The varied teeth produce incremental tones with changing pitch when the various regions translate across a striker.
In another variation of this fluid dispensing assembly, each of two reservoirs contains one component of a two-part fluid to be mixed prior to delivery. The reservoirs are coupled to a common portion of a dispensing conduit in a shaped tip applicator. An actuator delivers each adhesive component from its respective reservoir, into the dispensing conduit where they are mixed, and distally out of the applicator tip. Further to this variation, one chamber preferably houses a fibrinogen-containing fluid and the other chamber houses a fluid containing a catalyst for coagulating the fibrinogen, such as a thrombin-containing fluid.
In another aspect of the invention, a medical suction device assembly includes a vacuum conduit, a suction conduit, a vent conduit, and a valve manifold adapted to adjust the fluid communication between the vacuum conduit and the suction conduit while simultaneously and inversely adjusting the proportion of vacuum applied to the vent conduit. In this arrangement a controllable range of applied vacuum at the suction conduit may be selected by varying the proportion of vacuum pressure which is applied between the vent and the suction conduit.
In one variation of this medical suction device assembly, the valve manifold is engaged within a valve housing which includes a vent port in communication with the vent conduit, a suction port in communication with the suction conduit, and a vacuum port in communication with the vacuum conduit. The valve manifold has a valve wall forming a valve chamber and which includes a vacuum aperture, a suction aperture, and a vent aperture. The suction and vent apertures are adapted such that, by varying the positioning of the valve manifold between selected positions within the valve housing, they translate across the suction port and vent port, respectively, at the same time and while the valve vacuum aperture is registered with the vacuum port.
In a further variation, each of the suction and vent apertures also has a non-uniform cross section taken along an elongate axis thereof which is aligned with the axis of motion for translating across the corresponding valve housing port. Each of these two apertures is further positioned an the valve manifold in a relatively reciprocal orientation relative to the other, such that when the valve manifold is adjusted to register an increased-diameter portion of one aperture with its corresponding port, the other aperture has a decreased-diameter portion in registry with the other corresponding port.
In another aspect of the invention, a combination dispenser/suction device assembly includes an applicator tip portion with a suction conduit and a dispensing conduit. A valve manifold is adapted to shuttle an applied vacuum source between the suction conduit and the dispensing conduit.
In another aspect of the invention, an applicator/suction device assembly includes a dispensing pathway which is coupled at one end to at least one fluid reservoir and at the other end to a dispensing conduit in an applicator tip portion of the device. The dispensing conduit terminates distally at a tip dispensing aperture. A valve manifold is adapted to selectively interrupt the dispensing pathway by isolating the fluid reservoir from the dispensing conduit, and is further adapted to fluidly couple the dispensing conduit to a vacuum conduit which is further coupled to a vacu
Epstein Gordon Howard
Plyley Alan
Redmond Russell James
Baxter International Inc.
Handal & Morofsky
Oppenheimer Wolff & Donnelley
Seidel Richard K.
Thanh Loan H.
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