Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-02-20
2001-04-24
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S208000
Reexamination Certificate
active
06221053
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a medication delivery pen having a variety of features and, more particularly, a medication delivery pen that provides a mechanical advantage that uses less force to delivery the selected dose than would be needed to push directly on a plunger within a vial, a re-settable and/or repeatable dosing feature, and a self-priming feature all within the device using relatively few components.
2. Description of Related Art
Hypodermic syringes are used to deliver selected doses of medication to patients. The prior art hypodermic syringe includes a syringe barrel having opposed proximal and distal ends. A cylindrical chamber wall extends between the ends and defines a fluid receiving chamber. The proximal end of the prior art syringe barrel is substantially open and receives a plunger in sliding fluid tight engagement. The distal end of the prior art syringe barrel includes a passage communicating with the chamber. A needle cannula may be mounted to the distal end of the prior art syringe barrel, such that the lumen of the needle cannula communicates with the passage and the chamber of the syringe barrel. Movement of the plunger in a proximal direction draws fluid through the lumen of the needle cannula and into the chamber. Movement of the plunger in a proximal-to-distal direction urges fluid from the chamber and through the lumen of the needle cannula.
Medication to be injected with the prior art hypodermic syringe often is stored in a vial having a pierceable elastomeric seal. Medication in the prior art vial is accessed by piercing the elastomeric seal with the needle cannula. A selected dose of the medication may be drawn into the chamber of the syringe barrel by moving the plunger a selected distance in a proximal direction. The needle cannula may be withdrawn from the vial, and the medication may be injected into a patient by moving the plunger in a distal direction.
Some medication, such as insulin is self-administered. The typical diabetes patient will require injections of insulin several times during the course of the day. The required dose of insulin will vary from patient to patient, and for each patient may vary during the course of the day and from day to day. Each diabetes patient will establish a regimen that is appropriate for his or her own medical condition and for his or her lifestyle. The regimen typically includes some combination of a slow or medium acting insulin and a faster acting insulin. Each of these regimens may require the diabetes patient to periodically self-administer insulin in public locations, such as places of employment or restaurants. The required manipulation of the standard prior art hypodermic syringe and vial can be inconvenient and embarrassing in these public environments.
Medication delivery pens have been developed to facilitate the self-administration of medication. One prior art medication delivery pen includes a vial holder into which a vial of insulin or other medication may be received. The vial holder is an elongate generally tubular structure with proximal and distal ends. The distal end of the prior art vial holder includes mounting means for engaging a double-ended needle cannula. The proximal end also includes mounting means for engaging a driver and dose setting apparatus as explained further below. A disposable vial for use with the prior art vial holder includes a distal end having a pierceable elastomeric seal that can be pierced by one end of a double-ended needle cannula. The proximal end of this prior art vial includes a plunger slidably disposed in fluid tight engagement with the cylindrical wall of the vial. This prior art medication delivery pen is used by inserting the vial of medication into the vial holder. A prior art pen body then is connected to the proximal end of the vial holder. The pen body includes a dose setting apparatus for designating a dose of medication to be delivered by the pen and a driving apparatus for urging the plunger of the vial distally for a distance corresponding to the selected dose.
The user of the pen mounts a prior art double-ended needle cannula to the distal end of the vial holder such that the proximal point of the needle cannula pierces the elastomeric seal on the vial. The patient then selects a dose and operates the pen to urge the plunger distally to deliver the selected dose. The dose selecting apparatus returns to zero upon injection of the selected dose with this prior art medication delivery pen. The patient then removes and discards the needle cannula, and keeps the prior art medication delivery pen in a convenient location for the next required medication administration. The medication in the vial will become exhausted after several such administrations of medication. The patient then separates the vial holder from the pen body. The empty vial may then be removed and discarded. A new vial can be inserted into the vial holder, and the vial holder and pen body can be reassembled and used as explained above.
The above described medication delivery pen is effective and much more convenient for self-administration of medication than the hypodermic syringes that use separate medication vials. However, the above-described medication delivery pens require the user to continually set or reset the desired dose before each injection. As a result, users with impaired vision and fine motor skills have found it difficult to readily set the dose on such pens especially when using a medication delivery pen having a wide range of dosage settings available. Since it is particularly common among patients with diabetes to have complications of the disease causing impaired vision and fine motor skills even more of a need has been found to address this problem. Hence, it is necessary to provide a medication delivery pen having a simple mechanism for setting the desired dose, repeating the dose when necessary, and priming the medication delivery pen prior to use. It is also important to provide a medication delivery pen that makes the dispensing operation as easy as possible requiring as little force as necessary.
SUMMARY OF THE INVENTION
The present invention relates to a medication delivery pen that addresses the aboveidentified problems. The medication delivery pen has a repeat-dose feature that limits motion of the dose control mechanism using an adjustable repeat-dose stop on the dose knob. In addition, the medication delivery pen also provides the user a simple mechanism for setting and correcting the dose and a drive mechanism that makes the dispensing operation as easy as possible requiring as little force as necessary.
Another feature of the present invention is that the medication delivery pen provides a simple means for retracting the plunger when reloading the medication delivery pen with a new vial.
REFERENCES:
patent: 5279585 (1994-01-01), Balkwill
patent: 5292318 (1994-03-01), Haber et al.
patent: 5304152 (1994-04-01), Sams
patent: 5674204 (1997-10-01), Cvhanoch
patent: 5679111 (1997-10-01), Hjertman et al.
patent: 5725508 (1998-03-01), Chanoch et al.
patent: 5728074 (1998-03-01), Castellano et al.
patent: 5743889 (1998-04-01), Sams
Brooks Christopher J.
Fontayne Diego Y.
Walters Daniel A.
Becton Dickinson and Company
Fiedler, Esq. Alan W.
Kennedy Sharon
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