Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-04-15
2001-12-25
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S117000, C604S264000
Reexamination Certificate
active
06332875
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a manually operable needle injection-facilitating device intended for use as an aid in the injection of fluid medication by means of a hypodermic syringe or medication pen. The invention is particularly useful to patients who are frequently required to self-administer medication such as insulin in the case of diabetes.
The major difficulty that exists in the self-handling of a hypodermic syringe or medication pen by a person other than a trained professional is the accurate insertion and penetration of the needle into the skin of the patient. This problem is particularly compounded for individuals who are visually impaired, have an aversion to needles and injections, or lack fine motor control in attempting to administer their own medication.
DESCRIPTION OF BACKGROUND ART
Various injector assist devices for facilitating hypodermic injections for in-home use, such as for insulin injections, are known for operation with conventional hypodermic syringes while simultaneously controlling the depth of penetration of the hypodermic needle. However, for an individual with impaired vision or manual dexterity, these injector assist devices have a number of disadvantages that make them inconvenient and less desirable to use. One disadvantage associated with some present injector assist devices is that, by virtue of the number of components from which the devices are comprised, they are complicated with respect to assembly of the device. For example, in the case of U.S. Pat. No. 5,634,906 of Haber et al., several components of the apparatus are adapted with various peripheral retaining grooves and ridges so that they may interface precisely in combination with each component of a dose metering syringe, i.e. the medication housing, medication cartridge, needle hub and barrel. As such, considerable coordination is required to ensure that each component of the device is properly interfaced in combination with each component of the syringe so that it may function properly. Another disadvantage found among other injector assist devices is that they have components sized to accommodate only a limited number of commercial syringes and therefore, are not compatible with a medication pen. Examples of these devices are disclosed in U.S. Pat. No. 4,601,708 of Jordan and Canadian Patent No. 536,718 of Transue. On the other hand, some prior art injector devices are more simplistic in design, comprising essentially one tubular component adapted to fit over the barrel of a syringe. Such devices, described, for instance, in U.S. Pat. No. 5,417,662 of Hjertman et al. and U.S. Pat. No. 4,373,526 of Kling, have a number of angled surfaces within the interior wall of a tube, which are designed to inter-fit and inter-engage with annular projections of a conventional syringe barrel. However, the interlocking arrangement between the injector assist device and the syringe makes the device more difficult to manipulate in terms of its attachment to and/or removal from a syringe, especially for a person with poor manual dexterity.
SUMMARY OF INVENTION
Accordingly, an object of the invention is to provide an injector assist device comprised of a minimal number of component parts, which can be quickly and easily incorporated with either a conventional hypodermic syringe or a medication pen, is easy to handle and manipulate, and can reliably and safely facilitate administration of a medicament dosage, particularly by an individual who is visually impaired or lacks fine motor control.
Another object of the invention is to provide an improved needle injection-facilitating device which by function and structural design can accommodate a conventional hypodermic syringe or medication pen and which greatly simplifies and safely facilitates the self-injection procedure for in-home use application.
According to the invention there is provided a needle injection-facilitating device to aid in the positioning, guiding and stabilization of a hypodermic syringe or medication pen for subcutaneous injection, comprising in combination:
(a) an outer hollow cylindrical sleeve opening into an inverted frusto-conical base capable, in use, of shielding a hypodermic needle from view prior to and during an injection;
(b) an inner hollow cylindrical sleeve disposed within the outer sleeve and capable of sliding movement therein, between a retracted position and an operating position, said inner sleeve being adapted to receive a syringe or medication pen;
(c) biasing means disposed between the inner sleeve and the outer sleeve which upwardly biases the inner sleeve to said retracted position in which a hypodermic needle received within said inner sleeve is shielded from view by the base of said outer portion; and
(d) whereby upon placement of the conical base of said outer sleeve in contact with an injection site followed by application of a downward axial force to a syringe or medication pen received in said inner sleeve advances the inner sleeve from the retracted position to the operating position to effect administration of an injection; and subsequent removal of said downward force permits movement of said inner sleeve back to the retracted position and extraction of the hypodermic needle of said syringe or medication pen from the injection site.
Thus, the invention affords a needle injection-facilitating device designed for use with a hypodermic syringe or medication pen. The device comprises an outer hollow longitudinal cylindrical sleeve of larger diameter with an inverted frusto-conical base that allows a 90° angle of insertion of a hypodermic needle subcutaneously into a patient. In a second embodiment of the device, the frustoconical base is beveled to allow a 45° angle of insertion. By beveling the base of the outer sleeve in this way, a preferred angle of insertion at the targeted injection site can be achieved for a particular medical application while reducing the possibility of a bent syringe needle. The frusto-conical base also assists in guiding and stabilizing the movement of the hypodermic syringe, or medication pen, at a particular location by an individual who is visually impaired or lacks fine motor control. Furthermore, because the base of the outer sleeve shields the hypodermic needle from view prior to and during injection, the psychological barrier of needle insertion will be alleviated for the user who may experience anxiety at the sight of an exposed needle.
An inner hollow cylindrical sleeve of smaller diameter is slidably disposed within the outer sleeve and can hold various size adaptors to customize the device for use with a given type or size of syringe. Located at the distal end of the inner sleeve is a retaining collar with an aperture sized to receive the hub of a hypodermic needle and through which the needle projects. In a retracted position, the retaining collar rests inside a retaining groove circumscribed within the inner wall of the outer sleeve. A velcro patch may be attached on the outside face of the distal end of the inner sleeve and has a diameter and inner hole sized to match the dimensions of the retaining collar and its aperture, respectively.
The two sleeves slide along a common longitudinal axis in a telescopic arrangement and their movement relative to one another is controlled by biasing means, such as of spring means, which advantageously comprises springs disposed inside a pair or plurality of grooves set within the inner wall of the outer sleeve. The springs are compressed when an axial force is applied to the syringe prior to and during insertion of the hypodermic needle. In another embodiment of the injection needle-facilitating device, a single helical coil spring encircles the upper portion of the inner sleeve and seats on the peripheral edge at the extreme proximal end of the outer sleeve. An adjustable retaining ring located at the proximal end of the inner sleeve secures the spring to the device. Adjustment of the retaining ring will determine the tension of the spring and to a lesser degree, the extent of needle projectio
Inkpen Thomas Randall
Williamson Laura Jean
Schmeiser Olsen & Watts
Seidel Richard K.
Sirmons Kevin C.
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