Agitating – In vacuum chamber
Reexamination Certificate
2002-10-07
2003-06-03
Soohoo, Tony G. (Department: 1723)
Agitating
In vacuum chamber
C366S163100, C206S222000
Reexamination Certificate
active
06572256
ABSTRACT:
TECHNICAL FIELD
This invention relates to a multi-component transfer system for enabling at least two components to be positioned in a mixing chamber for subsequent processing.
BACKGROUND ART
In many surgical procedures, particularly orthopedic procedures, it has now become common to affix a prosthesis to a bone or joint structure for improving the strength, rigidity, and movement of the bone/joint structure. Although such prosthetic devices have been widely used, hip joints and knee joints are the most common examples of areas where prosthetic devices are used to reduce or eliminate pain and suffering that exists from typical leg movements.
As part of these operations, it has become common practice to secure the prosthesis to the bone or joint using a cement, formed by intermixing a powder and a liquid. Once intermixed, the two components must be thoroughly blended together to achieve the required consistency for the fully mixed cement, with the fully mixed cement then being loaded into a dispensing apparatus for placement in the desired area for affixing the prosthesis to the desired site.
In most applications, the two components forming the cement are mixed in a mixing vessel and, once fully mixed, are manually transferred from the mixing vessel to a dispensing member. Typically, devices such as caulking guns are employed, for dispensing the fully mixed cement to the precisely desired location of the patient. This process is extremely unpleasant for individuals mixing the cement, since the mixed cement contains an offensive, noxious odor. Furthermore, removal of the mixed cement from the mixing vessel into the caulking gun is cumbersome, time consuming, and has the potential for being mishandled and/or dropped.
Another problem typically encountered with prior art systems is the difficulty encountered with air being entrapped in the mixed cement. The presence of air pockets or air bubbles in the mixed cement is undesirable. Since it is important that the cement added to the bone area for affixing the prosthetic be virtually free of any entrapped air bubbles or air pockets, most prior art systems demand mixing of the powder and liquid under vacuum conditions. As a result, added limitations are incurred on the flexibility of the mixing vessel and the ability to mix the two-part cement mixture in any desired location.
Some prior art systems have enabled the mixing to be performed in one vessel which then is directly connected to a feeding system for enabling the mixed cement to be added to a holding tube for use with the dispensing caulking gun. However, a separate dispensing system is required and extra handling and exposure of the mixed cement to the surrounding personnel is required. Furthermore, care must be exercised during the transfer of the mixed cement to the dispenser, since air is frequently introduced into the cement during this transfer operation as well as the risk of dropping or spilling the material.
More recently, a unitary, fully integrated, bone cement mixing and dispensing system has been attained. This unique achievement is realized by creating a single housing or member which comprises a mixing chamber integrally combined with a delivery chamber or tube. The delivery chamber terminates with a portal through which the mixed bone cement is directly dispensed to any desired location.
In order to provide a mixing chamber which can be operated independently of the delivery chamber, the two chambers of the integrated system are movable between two alternate positions. In the first position, each chamber is sealed from the other, while in the second position, the two chambers are in direct communication with each other.
By employing this new development, the two components forming the bone cement are placed in the mixing chamber and intermixed, with complete assurance that no unmixed bone cement will enter the delivery chamber. Complete mixing of the bone cement is assured by providing, in some embodiments, an integrated counter and display which informs the operator the exact time at which the cement components have been thoroughly intermixed.
Once the two components forming the bone cement are fully intermixed with each other, to provide the desired bone cement product, the integrated, dual chamber system of the present invention is moved from its first sealed position to its second open position, enabling the fully mixed bone cement to be transferred from the mixing chamber directly into the delivery chamber. When desired and under the complete control of the operator, the mixed bone cement is advanced through the delivery chamber to a delivery portal, formed at the terminating end thereof. Then, the fully intermixed bone cement is dispensed through the portal directly to the desired location where the product is to be used.
Although this prior art integrated bone cement mixing and delivery system has been successful in overcoming many prior art problems, one problem that has continued to plague this industry is the difficulty encountered in the delivery, shipment, and transfer of the two components which form the bone cement. As is well-known, bone cement comprises a first component which consists of a dry powder and a second component which consists of a liquid monomer.
These components must be kept separate from each other until the user is ready to intermix the components to form the desired bone cement. Typically, the dry powder is stored in a flexible bag, pouch, or similar container, while the liquid monomer is stored for shipment and handling in a vial or tube, usually formed from glass.
In use, the container holding the dry powder which forms a first component is opened and the powder is placed in the mixing vessel. Then, when creation of the cement is desired, the glass vial or tube holding the liquid monomer is opened and the monomer is added to the powder. Thereafter, the two components are thoroughly intermixed with each other.
In attempting to expedite the opening of the vial or tube holding the liquid monomer, as well as reduce any exposure to the foul odor possessed by the liquid monomer, various prior art systems have been developed for enabling the user to insert the sealed vial or tube into an area of the mixing vessel and then break the vial or tube for releasing the liquid monomer directly into the dry powder.
These prior art systems all require that the broken glass pieces or shards of the vial/tube must be separately retained and prevented from reaching the cement product. In attempting to satisfy this requirement, substantial construction and operational difficulties have occurred with these prior art systems. Furthermore, in other prior art systems, manual addition of the monomer is required, exposing the user to the foul odor of the monomer and the substantial difficulties typically encountered in handling such products.
Therefore, it is a principal object of the present invention to provide a multi-component, product handling and delivering system which controllably enables the liquid monomer to be automatically delivered to the dry powder when desired.
Another object of the present invention is to provide a multi-component, product handling and delivering system having the characteristic features described above which comprises a fully integrated structure which eliminates the requirement for independent transfer of the components which form the mixed cement and eliminates the breakage of any vial or tube.
Another object of the present invention is to provide a multi-component, product handling and delivering system having the characteristic features described above which is easy to use and is virtually fool-proof in its operation.
Another object of the present invention is to provide a multi-component, product handling and delivering system having the characteristic features described above which provides intermixed bone cement virtually devoid of entrapped air pockets or air bubbles.
Another object of the present invention is to provide a multi-component, product handling and delivering system having the characteristic features d
Barker Donald
Seaton James P.
Immedica
Lowenstein & Sandler PC
Soohoo Tony G.
LandOfFree
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