Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Reexamination Certificate
1998-08-06
2002-03-19
Sykes, Angela D. (Department: 3735)
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
C604S403000, C604S411000, C604S416000, C604S905000
Reexamination Certificate
active
06358236
ABSTRACT:
FIELD OF THE INVENTION
This invention relates in general to a device for use in reconstituting medicaments into a solution suitable for injection into a patient, and in particular to a safe and ergonomic reconstitution device suitable for use with a syringe containing a fluid such as sterile water and a vial containing a lyophilized or powdered product, such as factor VIII, which provides a fluid passageway between the syringe and the vial, and includes a central vented spike extending from the middle of the device piercing the vial, and which has an overall design which greatly facilitates reconstitution of important blood factors.
BACKGROUND OF THE INVENTION
Over the past few years, many patients suffering from blood diseases such as hemophilia who require daily intravenous injections have benefitted from the increased availability of lyophilized (freeze-dried) concentrates of blood factors such as Factor VIII. These freeze-dried blood factor concentrates, such as RECOMBINATE® brand recombinant factor VIII protein manufactured by Baxter Healthcare Corporation, are extremely advantageous in that they may be readily stored for longer periods of time prior to use with less risk of contamination. As a result, these products are ideal for home use and have benefitted many patients who can utilize these products on their own and avoid costly and time-consuming in-patient procedures at a clinic or hospital in order to receive the necessary injections.
However, a major drawback to the widespread use of blood factor concentrates on an out-patient basis has been the need to efficiently and safely reconstitute the lyophilized product prior to injection into the patient. In particular, there are several obstacles that must be overcome by patients who would like to use these lyophilized concentrates at home. First and foremost, most conventional methods of reconstitution currently require the use of a hypodermic syringe that pierces the stopper of a vial containing the lyophilized product, and thus the dangers associated with exposed hypodermic needles at any point of the process must be reduced or eliminated. Considering that the major users of these concentrates will be hemophilia patients, one can easily recognize the great potential harm if such a person is inadvertently pricked by a hypodermic needle.
Moreover, another major obstacle that must be overcome is that the primary users of blood factor concentrates will be patients with hemophilia (Factor VIII deficiency) who often suffer from joint damage and as a result face substantial physical obstacles in manipulating the devices which must be used in order to reconstitute the dried product and inject the resulting solution. As a result, it is important that a means be developed which will allow such patients to reconstitute and utilize a concentrated blood product without requiring undue pressure or force, and without the need for complex manipulation that may be difficult or impossible for a hemophilia patient to carry out.
Finally, keeping in mind that the average patient will not be a trained healthcare professional, it is extremely important that a device for use in reconstituting a dry blood factor concentrate be intelligently and ergonomically designed so that the patient will easily understand how to operate it safely and effectively. For example, since the reconstitution process will very often make use of a glass syringe or vial, it is necessary that the patient be able to grasp such a device properly so as to avoid any possibility of breaking the syringe or vial which, for reasons as stated above, will increase the chance of an inadvertent cut which would be of great potential harm. In addition, since the blood factor concentrates themselves are often expensive, it is very important for the patient to be able to maximize the reconstitution of the lyophilized concentrate in the vial, and to minimize any steps where inadvertent loss or spillage of this concentrate might occur.
At present, although there have been many devices that have been developed which relate to the reconstitution of a medicament using a syringe which injects a fluid into a vial, no one prior reconstitution device or system has been able to overcome all of the above-mentioned obstacles and provide an ergonomic, safe and effective means for reconstituting a blood factor concentrate which can be utilized by the patient at home if necessary without assistance from a healthcare professional. Among the many devices in this field include those disclosed in U.S. Pat. Nos. 5,554,128; 5,520,659; 5,247,972; 5,158,558; 5,171,214; 5,137,511; 5,125,908; 5,088,996; 4,834,149; and 4,768,568.
However, in no cases do these references provide a simple, safe and effective reconstitution system or device which is ergonomically designed to maximize ease of use by a patient, and which can be safely and efficiently operated so as to maximize the reconstitution of a blood factor concentrate, while minimizing or avoiding problems associated with breakage of the syringe or vial, inadvertent exposure of the syringe needle, and inadvertent loss or spillage of the valuable and expensive blood factor concentrate that will be injected into the patient.
SUMMARY OF THE INVENTION
Accordingly, it is thus an object of the present invention to provide a reconstitution device which can be used safely and effectively by hemophilia patients which eliminates the possibility of the user being inadvertently pricked by an exposed hypodermic needle during the reconstitution process.
It is further an object of the present invention to provide an ergonomically designed reconstitution device which can facilitate the reconstitution of a lyophilized product such as a blood factor concentrate so that it can readily be operated by a human patient on an out-patient basis without the need for assistance by a healthcare professional.
It is even further an object to provide a safe and effective reconstitution device which contains means to equalize pressure during the piercing of a stopper on a sterile, vacuum-packed vial.
It is still further an object of the present invention to provide a reconstitution device which is easy to manipulate, and which does not require excessive force or pressure to be operated so that it can be readily used even by elderly patients or patients suffering from joint disease or other physical limitations.
These and other objects are achieved by virtue of the present invention which provides a reconstitution device for use in reconstituting a lyophilized product contained in a sealed vial using fluid introduced into the vial by means of a syringe, said reconstitution device comprising a housing having an upper section capable of receiving a syringe and a lower section capable of receiving a vial, said upper and lower sections positioned so that the syringe and vial are in co-axial alignment, and a middle section connecting the upper and lower sections having an aperture through which fluid from a syringe housed in the upper section can be introduced into a vial housed in the lower section, and having a central vented spike extending downwardly from the aperture in the middle section which extends to a length sufficient to ensure that the lower end of the spike will enter the interior of a vial when housed in the lower section. The vented opening in the central spike is advantageous primarily because it will allow for an equalization of the pressure following the piercing of the stoppered vial by the sharpened end of the spike. In the preferred embodiment, the outermost portion of the lower section will be flared and will contain flanges so as to provide a suitable shape for proper gripping and manipulation of the reconstitution device which will facilitate proper use of the device and virtually eliminate mishandling of the syringe or vial which could result in inadvertent breakage and potential injury to the patient.
These and other objects and advantages of the invention will be disclosed in, or become apparent from, the detailed description of the preferred embodiments provided
Bilstad Arnold
DeFoggi John Mark
McPhilliamy Ingrid
Baxter International Inc.
Bianco Patricia
Larson & Taylor PLC
Sykes Angela D.
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