Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2000-11-10
2003-02-04
Truong, Kevin T. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S181000
Reexamination Certificate
active
06514270
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a single use lancet device structured to be conveniently and effectively utilized for various blood sampling procedure, but which is also substantially safe, preventing re-firing of the device after it has been used, and thereby preventing and/or substantially minimizing inadvertent contamination of a patient and/or other personnel as a result of a used and potentially contaminated lancet. Furthermore, the device is compact and easy to utilize in a cost effective and preferably fully disposable manner.
2. Description of the Related Art
Lancets are commonly utilized instruments which are employed both in hospitals and other medical facilities, as well as by private individuals, such as diabetics, in order to prick or pierce a patient's skin, typically on a finger of a patient, thereby leading to the generation of a blood sample which can be collected for testing. Because of the wide spread use of such lancets, there are a variety of lancet devices which are available for utilization by patients and/or practitioners in a variety of different circumstances.
For example, a typical lancet may merely include a housing with a sharp piercing tip that is pushed into the patient's skin. More commonly, however, lancet devices, which house a piercing tip and/or a lancet, have been developed which effectively encase and fire the lancet into the patient's skin, thereby eliminating the need for the person taking the sample to actually push the lancet tip into the skin.
Within the various types of specialized lancet devices, one variety are typically configured for multiple and/or repeated uses, while another category is particularly configured for single use, after which the entire device is disposed of. Looking in particular to the single use, disposable lancet devices, such devices typically include a housing which contains and directs or drives a piercing tip into the patient's skin, and which is disposed of along with the used lancet. Naturally, so to make such disposable devices cost effective for frequent use, such devices tend to be rather simplistic in nature providing only a sufficient mechanism for firing, and not overly complicating the design so as to minimize that cost.
While existing single use devices are generally effective for achieving the piercing of the skin required for effective operation, such single use, disposable devices typically do not incorporate a large number of safety features to ensure the safe use and disposal of the device. For example, one primary area of safety which must be addressed with all lancet devices pertains to the purposeful and/or inadvertent reuse of a contaminated lancet. Unfortunately, most currently available single use lancet devices are configured such that after a use thereof has been achieved, it is possible for a patient to re-cock the device, thereby allowing for a subsequent, inappropriate use.
As a result, it would be highly beneficial to provide a single use lancet device which is substantially compact and disposable, can be manufactured in a substantially cost effective manner, and which nevertheless is substantially safe to utilize, affirmatively preventing re-use, once contaminated. Additionally, it is noted that while other devices may be provided to prevent the lancet form even being cocked, it would still be beneficial to provide a device that even if the lancet is re-cocked does not allow for additional and/or secondary firing.
SUMMARY OF THE INVENTION
The present invention is direct to a single use lancet device of the type commonly utilized for various blood sampling purposes. In particular, the single use lancet device of the present invention includes a housing and a lancet. The lancet, which also includes a piercing tip, is movably disposed in the housing and is structured to move at least between a cocked orientation and a piercing orientation. A drive assembly is provided so as to actually move the lancet at least temporarily into the piercing orientation.
In order to retain the lancet in the cocked orientation, the illustrated embodiment of the single use lancet device of the present invention includes a retention member and a engagement hub. In particular, the engagement hub is structured to be cooperatively engaged with the retention member, at least when the lancet is disposed in the cocked orientation. As a result, the retention member and the engagement hub, which are cooperatively engaged with the housing and the lancet, effectively maintain the lancet in the cocked orientation until they are released from that engagement with one another. As such, it is seen, in this embodiment, that when the lancet is ready for use, it is maintained in the cocked, ready to fire orientation until that time.
In order to release the lancet, and more particularly the cooperative engagement between the retention member and the engagement hub of the illustrated embodiment, the present invention further includes an actuation assembly. Specifically the actuation assembly is structured to move between an actuated and an un-actuated orientation. In this regard, movement of the actuation assembly into the actuated orientation is structured to release at least the retention member and the engagement hub from their cooperative engagement with one another, thereby resulting in movement of the lancet into the piercing orientation.
In order to substantially minimize the inadvertent re-use of the single use lancet device of the present invention, a restrictor assembly is also preferably provided. Specifically, the restrictor assembly is structured to substantially prevent the actuation assembly from moving out of the actuated orientation, at least after the lancet has moved at least temporarily into the piercing orientation. In this regard, the restrictor assembly may include an abutment structure that is cooperatively disposed between the housing and a release element of the actuation assembly that actually releases the retention member and the engagement hub from their cooperative engagement with one another. As such, once the lancet device of the present invention has been fired the actuation assembly cannot move back into its un-actuated orientation for a subsequent firing, regardless of whether the lancet itself may or may not be moved back into the cocked orientation.
These and other features and advantages of the present invention will become more clear when the drawings as well as the detailed description are taken into consideration.
REFERENCES:
patent: 5147375 (1992-09-01), Sullivan et al.
patent: 5908434 (1999-06-01), Schraga
Malloy & Malloy P.A.
Truong Kevin T.
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