Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2000-01-05
2001-11-27
O'Connor, Cary E. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
Reexamination Certificate
active
06322575
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a lancet depth adjustment assembly structured to be interposed between a body part to be pierced, such as a patient's finger or earlobe, and a piercing aperture of a lancet device housing, so as to affectively define and vary a depth to which a piercing tip of the lancet is able to penetrate the patient's body part disposed thereon. As such a patient can affectively select and define a sensitivity level that corresponds their particular needs and circumstance in a substantially easy to use manner which effectively maintains the finger properly positioned and is configured so as to be conveniently and cost effectively configured for utilization with a wide variety of existing lancet device designs.
2. Descriptio of the Related Art
Lancet devices are commonly utilized devices which allow patients and medical practitioners to “prick” a patient's skin in order to effectively obtain a blood sample for a variety of tests. Typically these lancet devices involve the driving of a lancet tip into the patient's skin so as to result in bleeding by the patient, thereby allowing the sample to be gathered. Moreover, although these tests are often performed in a hospital or laboratory environment, because of the prevalence of many home testing kits, more and more, individual patients are turning to self testing, and as a result, independently utilize the lancet device so as to obtain their own blood sample.
Conventional lancet devices available in the art typically range from single use, disposable lancets, to re-useable lancet devices wherein an individual lancet can be removed and replaced after each use. Moreover, as a result of the increasing popularity of blood testing procedures, especially by individual patients, the field of art associated with lancet devices is quite crowded, with a variety of often complex and intricate structures being utilized to drive the piercing tip of the lancet into the flesh of a patent. In particular, the typical lancet device generally utilizes a disposable lancet, often of a standard dimension, contained in a housing for firing. As such, a variety of different, lancet devices have been provided, some providing for re-use through internal or external cocking of the firing mechanism and providing an actuation button on a side thereof for triggering of the piercing action.
Typically, most conventional lancet devices are constructed such that when fired the piercing tip of a particular lancet protrudes, at least temporarily, a defined amount from a piercing aperture of the housing. This amount or depth to which the piercing tip protrudes is traditionally a standard amount which is sufficiently effective to pierce the skin of most patients, thereby resulting in generation of the blood sample. Unfortunately, with some types of lancets, some patients and/or depending upon the circumstance, the standard depth which the piercing tip protrudes may not be ideal. For example, lancet devices typically are set to pierce a maximum depth which is acceptable to most individuals and may be necessary for some patients, such as those experiencing swelling, the formation of a callous, and/or who have normally thicker skin. Conversely, however, some patients, either at all times or at selective times depending upon their condition, are very sensitive and excessive penetration can lead to excessive bleeding and/or a substantially amount of pain. As a result, in such patients a standard, maximum depth is generally undesirable. Furthermore, it is also recognized that a wide spectrum of different lancet gauges are becoming increasingly available, with many companies turning to the manufacture of thinner gauge lancets which are necessarily longer. For example, a thicker gauge lancet does not have to penetrate as far to produce a sufficient sample, while thinner gauge lancets must penetrate further to produce a sufficient sample. Unfortunately, however, the increased penetration that results from the longer, thinner lancets, tends to be more painful and may therefore be excessive for some patients.
Accordingly, it would highly beneficial to provide a depth adjustment assembly which is substantially accurate and easy to utilize, and which allows a patient to effectively vary a depth to which a piercing tip of the lancet would penetrate their skin. Furthermore, such a depth should be adjustable either a single time, for patients that have a requirement for a varied and specific depth on a permanent basis, or on a variable basis for patients who require different depths at different times. Indeed, such a configuration would be particularly beneficial if a common device needs to be utilized by many different patients, such as in a household with multiple diabetics, merely by replacing the used lancet with a new, sterile lancet. (Of course, such multi-patient use of a lancet device is never recommended.)
It would also be beneficial to provide such a depth adjustment assembly which is substantially effectively and accurate, and is also cost effective and convenient to implement on a wide variety of existing lancet device configuration. For example, many individuals have particular preferences and/or needs with regard to the specific lancet devices that they utilize and/or have become accustomed to utilizing. As a result, it would be beneficial to provide a depth adjustment assembly which can be effectively configured for utilization with a majority of such lancet device designs, providing those designs with a beneficial degree adjustability, without affecting their normal mode of operation.
SUMMARY OF THE INVENTION
The present invention relates to a lancet depth adjustment assembly. In particular, the lancet depth adjustment assembly is structured to be used with a lancet device, preferably of the type that includes a lancet movably disposed within a housing and structured to at least temporarily move into a piercing orientation wherein a piercing tip of the lancet protrudes from a piercing aperture defined in the housing. Moreover, the lancet device is preferably of the type that protrudes the piercing tip a predetermined, uniform amount, each time it is used.
Preferably, the lancet depth adjustment assembly includes a depth adjustment element. The depth adjustment element is preferably movably secured in at least partially and/or temporarily overlying relation to the piercing aperture of the housing. Of course, the piercing aperture of the housing may be of a finite size, and/or may comprise a completely open end of the housing, with the depth adjustment element being disposed operatively thereover.
The depth adjustment element further includes a piercing access. In particular, the piercing access is structured to permit passage of the piercing tip of the lancet therethrough after it has passed through the piercing aperture of the housing. As such, the depth adjustment element is structured and disposed to be at least temporarily and at least partially interposed between a body part, such as the finger, of a patient and the piercing aperture during use of the lancet device.
The depth adjustment element is thereby structured to define a spacing between the patient's finger and the piercing aperture, and in turn define a depth to which the piercing tip can penetrate the finger. For example, as the piercing tip is generally configured to pass a predefined distance through the piercing aperture of the housing, a larger spacing between the finger and the piercing aperture, as defined by the depth adjustment element, reduces the depth to which the piercing tip ultimately penetrates the finger.
Although variable spacing is preferably provided by a single adjustable depth adjustment element, as will be described, if desired, interchangeable, different sized depth adjustment elements may be provided so as to vary the spacing. Preferably the depth adjustment element includes a varying thickness. In particular, the varying thickness is provided so as to vary a spacing between an exterio
Malloy & Malloy P.A.
O'Connor Cary E.
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