|Publication number||USRE43329 E1|
|Application number||US 10/410,911|
|Publication date||Apr 24, 2012|
|Filing date||Apr 10, 2003|
|Priority date||Dec 18, 1997|
|Also published as||CA2256593A1, CA2256593C, DE69840664D1, EP0925799A2, EP0925799A3, EP0925799B1, EP2058023A2, EP2058023A3, US6033384, US6213982, USRE45589|
|Publication number||10410911, 410911, US RE43329 E1, US RE43329E1, US-E1-RE43329, USRE43329 E1, USRE43329E1|
|Original Assignee||Medical Instill Technologies, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (20), Referenced by (1), Classifications (18), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of prior application Ser. No. 08/993,969, filed Dec. 18, 1997, now U.S. Pat. No. 6,033,384.
1. Field of the Invention
The invention relates generally to a mechanism for dispensing medicament via an outlet nozzle, and relates more particularly to a one-way actuation release mechanism for a medicament dispensing system for applying medicament from a vial-dispenser of the type which is actuated by compression or movement of a trigger.
2. Description of Related Art
Amongst various dispensers for applying medicament, a typical medicament container includes a flexible vial storage portion and a nozzle for dispensing medicament by squeezing the vial between its side walls. Another type of medicament dispenser is an accordion-like or piston-like dispenser which is actuated by squeezing the vial between a bottom wall and the nozzle so as to compress the vial in its longitudinal direction, rather than from its sides. The present invention is particularly directed to a dispensing system which includes such an accordion-like or piston-like dispenser, although the present invention may be used in conjunction with other types of dispensers. An example of the piston-like dispenser which ejects precalibrated dosage of medicament is described in detail in my U.S. Pat. No. 5,613,957 which is expressly incorporated herein by reference.
Normally, several factors contribute to difficulty in applying medicament. First, elderly people often encounter difficulty in holding the dispenser steady or squeezing the dispenser to apply a proper quantity of medicament. In addition, even for young persons who are able to hold the dispenser steady, actuation of certain types of dispensers creates problems in accurate application of medicament. For example, application of medicament using a common type of nasal dispenser requires initial placement of the nozzle tip inside the nostril, followed by withdrawal of the nozzle tip from the nostril due to the compression of the dispenser at the time of ejection of medicament, which may result in accidental application of medicament to the eyes or other unintended targets.
Even if the medicament is properly applied as intended, typically the dispensed dose of medicament will vary with the speed and/or the force of actuation of the pump mechanism. In addition, the spray pattern, or the plume, of the dispensed medicament will also vary with the speed and/or the force of actuation of the pump mechanism.
Yet another problem associated with medicament dispensers is manufacturing complexity: pump-type medicament dispensers are currently made of numerous parts and are highly delicate to assemble. Many of the pump-type dispensers incorporate springs, which pose problems in the manufacturing process for the dispensers because of the springs' tendency to get intermingled.
One attempt to solve the above-described problems associated with applying medicament from a dispenser is described in my U.S. Pat. No. 5,267,986, which discloses a system including a cartridge for actuating a piston-like or accordion-like vial-dispenser for applying medicament to an eye. The cartridge disclosed in U.S. Pat. No. 5,267,986 includes: a housing for holding the vial-dispenser; a telescoping cylinder for compressing the vial-dispenser in the longitudinal direction to load the vial with medicament; a locking mechanism for locking the telescoping cylinder and the vial-dispenser in the loaded position, against the urging of a spring mechanism of the vial-dispenser; and a trigger mechanism for releasing the telescoping cylinder and the vial-dispenser from the locked position to release the medicament loaded in the dispenser by means of the force of the spring mechanism. In order to obviate the need for a discrete spring element in the pump mechanism of the vial-dispenser, a portion of the vial-dispenser body is made of an elastic material which is compressible and provides spring force. The two-step process in which the cartridge disclosed in U.S. Pat. No. 5,267,986 loads and subsequently releases the medicament from a vial-dispenser defines the basic operation a “reverse pump,” an example of which is described in U.S. Pat. No. 5,613,957.
The dispensing system disclosed in U.S. Pat. No. 5,267,986 addresses the previously-mentioned problems by enabling a user to apply a predetermined dose of medicament independent of the physical force applied to the dispensing system by the user: the releasing force or speed of the dispensed medicament is dependent on the integral spring element of the dispensing system. Whereas conventional pump-type dispensers often utilize compression along the longitudinal axis for release of medicament, the actuation motion of the release mechanism described in U.S. Pat. No. 5,267,986 is preferably achieved in a direction perpendicular to the longitudinal axis of the vial-dispenser to ensure enhanced leverage for the user.
Because elastic materials, particularly elastomeric materials and springs, tend to exhibit hysteresis, spring force decreases if the spring mechanism is kept in the compressed position, i.e., in the loaded, locked position. Although the deformation of spring is generally reversible if the spring is returned to, and maintained in, the unbiased state for some period, some of the deformation becomes irreversible, or experiences “creep,” if the spring is kept in the compressed state beyond a certain threshold period of time, which threshold period varies with the spring material. The amount of loss of spring force is dependent on the tendency of a particular spring material to “creep,” and it is known that metal springs tend to exhibit much less “creep,” than plastic springs. The hysteresis of elastic materials used to form the spring mechanism of the pump described in U.S. Pat. 5,613,957 is due to loss of some of the spring property when the spring element remains in the compressed state for an extended period of time.
Two examples illustrate the practical implications of the above-mentioned hysteresis problem-in connection with the dispensing system disclosed in U.S. Pat. No. 5,267,986. As a first example, a user places the dispensing system in the loaded state but does not actuate the release mechanism for several minutes due to an interruption. When the release mechanism is finally actuated, hysteresis of the spring mechanism causes the dosage of released medicament to vary from the dosage calibrated to be released under normal conditions. As a second example, a user places the dispensing system in the loaded state but subsequently forgets about the loaded system; the user does not actuate the release mechanism for several weeks or months. In this situation, not only will the initially-released dosage vary from the calibrated dosage, but subsequently-dispensed dosages will also vary from the calibrated dosage due to a type of permanent deformation, or “creep,” that has occurred.
In view of the above-described problem of spring deformation, it would be desirable to have a medicament-dispensing system which allows the user, by means of a single actuation motion, to load the vial with medicament and dispense the medicament.
It is an object of the invention to provide a medicament-dispensing system which can accurately deliver a small, calibrated amount of medicament by means of a single actuation motion which initially loads the system with medicament and subsequently dispenses the loaded medicament.
It is a further object of the invention to provide such a system which includes an actuation mechanism for actuating a vial-dispenser of the type having a spring configuration, e.g., an accordion-like or piston-like vial-dispenser, which actuation mechanism requires minimal force for actuation.
It is a further object of the invention to provide such a system which substantially eliminates any possibility that spring elements of the dispensing system will exhibit hysteresis of spring characteristics.
It is a further object of the invention to provide such a system which ensures that the discharged dosages do not substantially deviate from the calibrated dosage.
It is a further object of the invention to provide such a system in which the actuation motion of the actuation mechanism for dispensing the loaded medicament is in the direction perpendicular to the longitudinal axis of the vial dispenser to ensure enhanced leverage for the user and to avoid the actuation motion being parallel to the compression axis of the spring element.
It is a further object of the invention to provide such a system which can accurately deliver a small, calibrated amount of medicament in a stable manner independent of the physical force applied by the user to the actuation mechanism.
It is a further object of the invention to provide a system having these features which has a simple construction and which is easy to manufacture by virtue of reduced number of components, particularly by virtue of eliminating the need for a discrete spring element.
It is a further object of the invention to provide a method of accurately delivering a small, calibrated amount of medicament by means of a single actuation motion of a medicament-dispensing system which initially loads the system with medicament and subsequently dispenses the loaded medicament.
It is a further object of the invention to provide a method of dispensing a small, calibrated amount of medicament by means of an actuation mechanism for actuating an accordion-like or piston-like vial-dispenser, which actuation motion requires minimal force for actuation.
The foregoing objects are achieved by the present invention which provides a medicament-dispensing system in which a cartridge or housing is particularly adapted for actuating an accordion-like or piston-like vial-dispenser. The vial-dispenser has an accordion-like front bellows portion near the anterior end, a rear vial section or liquid storage chamber at the posterior end, and a rear bellows portion located between the front bellows portion and the rear vial section. A drop cavity or a dosage cavity, which may be located within either the front bellows portion or the rear bellows portion, holds a precalibrated amount of medicament loaded from the liquid storage chamber. In addition, an internal piston mechanism within the vial-dispenser acts in concert with the front and rear bellows portions to expel the medicament contained in the drop cavity.
The housing includes a generally elongated body portion which is adapted to receive the vial-dispenser between an anterior wall and a posterior wall of the housing. The posterior wall of the housing may form a portion of a rear chamber of the housing, in which case the rear chamber of the housing receives the rear vial section of the vial-dispenser. The anterior wall of the housing has an aperture for exposing the nozzle of the vial. The nozzle is preferably receded within the anterior portion of the housing so that it does not project out of the opening so as to prevent any corneal injury in the event of accidental contact of the anterior portion with the eye.
Located on top portion of the housing is a hook-shaped trigger mechanism which, when depressed, acts via, and in concert with, a notched lever located in the interior portion of the housing to extend the front bellows portion and compress the rear bellows portion of the vial-dispenser in the longitudinal direction, away from the anterior wall of the housing and towards the rear chamber. In the case of the exemplary embodiment of the vial-dispenser described herein, extension of the front bellows portion and compression of the rear bellows portion cause a precalibrated dose of medicament to enter the dosage cavity located in the front of the dispenser, thereby “loading” the dosage cavity.
Continuing with the triggering motion, once the notched lever located in the interior portion of the housing has extended the front bellows portion of the vial-dispenser a predetermined distance, the notched lever is disengaged from the front bellows portion by a wedge-shaped arm extending from the rear wall of the housing. Upon disengagement from the notched lever, the front bellows portion contracts and the rear bellows portion extends towards the anterior wall of the housing. In concert with the movements of the front and rear bellows portions, movement of the internal piston mechanism creates pressure which forces the medicament from the dosage cavity via the anterior nozzle of the vial-dispenser.
The medicament-dispensing system according to the present invention includes a housing or cartridge 100, shown in
As shown in
As shown in
As shown in
As shown in
From the rest position illustrated in
Continuing with the actuation sequence, further depression of the trigger 101 causes the notched lever 102 to eventually reach a position where the notched lever comes in contact with the wedge-shaped arm 103. At this point, the wedge-shaped arm engages the notched lever 102 and lifts the notched lever clear of the rear wing 6, as shown in
If the medicament dispensing system according to the present invention is to be used for application of medicament to the eyes, the lower anterior section of housing 100 may be additionally equipped with a forwardly projecting finger 107 which extends from the housing 100 beyond the anterior wall 104, as shown in
As can be seen from the above description, one advantage of the dispensing system according to the present invention is that there is virtually no possibility of the front and rear bellows portions exhibiting hysteresis of spring characteristics since the front and rear bellows portions are never “locked” in a deformed state for an extended period of time. Accordingly, the dispensing system according to the present invention ensures that the discharged dosages do not substantially deviate from the calibrated dosage.
Another advantage of the dispensing system according to the present invention is that the actuation motion of the trigger 101 is perpendicular to the longitudinal axis of the dispensing system. Accordingly, there is little danger of accidental poking of the eyeball with the nozzle 2 since the motion to depress the trigger is not in the direction of the eye.
Yet another advantage of the dispensing system according to the present invention is that a single actuation motion of the trigger 101 enable the user to both load the drop cavity and subsequently discharge the precalibrated amount of medicament. The dispensing system according to the present invention is particularly useful for arthritic patients because the trigger mechanism allows for easy release of a medicament drop, thereby enabling more accurate delivery of the medicament drop to the eye. Furthermore, if the lower anterior section of housing 100 is equipped with a forwardly projecting finger 107, cul de sac of the eye, an area of low sensitivity and low tear turn over, may be specifically targeted by the present invention for application of medicament since the projecting finger 107 allows exposing of the cul de sac of the eye.
In the foregoing specification, the invention has been described with reference to specific exemplary embodiments thereof. It will, however, be evident that various modifications and changes may be made thereunto without departing from the broader spirit and scope of the invention as set forth in the appended claims. For example, the cartridge or housing may be adapted for use in conjunction with various types of vial-dispensers not specifically described herein, for example the vial-dispenser which is described in my U.S. Pat. 5,613,957 which has been expressly incorporated herein by reference. Furthermore, the spring action provided by flexible plastic material forming the front and rear bellows may be alternatively provided by a longitudinally disposed spring which urges the vial-dispenser to return to original position upon being released from the compressed state. In addition, although the vial-dispenser has been described in this specification as having an accordion-like front bellows portion and a rear bellows portion, the dispenser may alternatively incorporate any other spring configuration, e.g., a single spring element which is either integral with the dispenser body or separately formed. Furthermore, the specific arrangement of the trigger 101, the notched lever 102 and the wedge-shaped arm 103 may be modified, e.g., the trigger 101 and the notched lever 102 may be formed separately from one another and/or from the housing 100. The specification and drawings are accordingly to be regarded in an illustrative rather than a restrictive sense.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4053086||Mar 31, 1976||Oct 11, 1977||Aerosol Inventions & Development S.A. Aid Sa||Pumps for hand-held dispensers|
|US4575375 *||Nov 2, 1984||Mar 11, 1986||George Kozam||Periodontal pocket irrigating and medication delivery dispenser and gel system|
|US4623337||Mar 8, 1984||Nov 18, 1986||Alpha Group, Inc.||Liquid dispensing apparatus|
|US4694977||Sep 11, 1984||Sep 22, 1987||Ing. Erich Pfeiffer Gmbh & Co. Kg||Fluid dispenser|
|US4944430||Aug 7, 1987||Jul 31, 1990||Ing. Erich Pfeiffer Gmbh & Co. Kg||Fluid dispenser|
|US4946452||Nov 4, 1988||Aug 7, 1990||Py Daniel C||Ocular treatment apparatus|
|US4981479||Dec 19, 1989||Jan 1, 1991||Py Daniel C||Ocular treatment apparatus|
|US5024355||Dec 20, 1989||Jun 18, 1991||Societe Technique de Pulverisation--STEP||Device for dispensing a liquid or a cream in small-volume drops, and an associated dispensing assembly|
|US5133702||Dec 28, 1990||Jul 28, 1992||O.P.T.I.C.||Ocular treatment apparatus|
|US5205441 *||Dec 20, 1991||Apr 27, 1993||Firma Raimund Andris Gmbh & Co. Kg.||Suction and/or discharge valve for a metering and spray pump for dispensing liquid, low-viscosity and pasty substances|
|US5238156||Dec 20, 1991||Aug 24, 1993||Firma Raimund Andris Gmbh & Co., Kg.||Metering and spray pump for dispensing liquid, low-viscosity, and pasty substances|
|US5238845 *||Jul 29, 1992||Aug 24, 1993||Instrumentation Laboratory S.P.A.||Method for producing a co2 calibration liquid|
|US5267986||Apr 6, 1992||Dec 7, 1993||Self-Instill & Co., Inc.||Cartridge for applying medicament to an eye from a dispenser|
|US5320845||Jan 6, 1993||Jun 14, 1994||Py Daniel C||Apparatus for delivering multiple medicaments to an eye without premixing in the apparatus|
|US5401259||Oct 6, 1993||Mar 28, 1995||Py Daniel C||Cartridge for applying medicament to an eye|
|US5613957||Mar 11, 1994||Mar 25, 1997||Daniel Py||Apparatus for applying medicament to an eye|
|EP0201809A1||Aug 15, 1984||Nov 20, 1986||Ing. Erich Pfeiffer GmbH & Co. KG||Fluid dispenser|
|EP0492354A1||Dec 17, 1991||Jul 1, 1992||Raimund Andris GmbH & Co. KG||Dosing and spraying pump for dispensing liquid, low viscous and paste-like material|
|WO1992020455A1||May 15, 1992||Nov 26, 1992||Rosaria Galli & C. S.A.S.||Mechanical self-actuated system for medicament atomizing dispensers|
|WO1993010852A1||Dec 1, 1992||Jun 10, 1993||Self-Instill & Co., Inc.||Apparatus for applying medicament to an eye|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8550131||Jan 2, 2013||Oct 8, 2013||Liquid Squeeze, LLC||Liquid dispensing device, system and method|
|U.S. Classification||604/186, 604/153, 222/210|
|International Classification||A61M31/00, A61M5/178, B05B11/00, A61F9/00|
|Cooperative Classification||A61F9/0026, B05B11/3095, B05B11/3011, B05B11/3076, B05B11/3092, A61M11/00|
|European Classification||A61F9/00B4, B05B11/30C5B, B05B11/30P4, B05B11/30H8D, B05B11/30S|
|Jul 3, 2012||CC||Certificate of correction|
|Oct 1, 2012||FPAY||Fee payment|
Year of fee payment: 12
|May 8, 2014||AS||Assignment|
Owner name: DR. PY INSTITUTE LLC, CONNECTICUT
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MAEJ LLC, C/O O DONNELL & TESSITORE LLP;REEL/FRAME:032847/0231
Effective date: 20140312
|Jun 4, 2014||AS||Assignment|
Owner name: MAEJ LLC, C/O O DONNELL & TESSITORE LLP, MASSACHUS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MEDICAL INSTILL TECHNOLOGIES, INC.;REEL/FRAME:033083/0595
Effective date: 20080620