US20070179449A1

Movatterモバイル変換

Info

Publication number: US20070179449A1
Application number: US11/544,430
Authority: US
Inventors: Irwin Berman; Richard Gillespie; Gervasio Salgado
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-06-04
Filing date: 2006-10-06
Publication date: 2007-08-02
Also published as: US7141036B2; US20030225358A1

Abstract

A device60, for administering medicated cream, includes a cartridge62for containing the cream, a plunger head100for moving the cream from within the cartridge, and a stem106for moving the plunger head within the cartridge. The plunger head100includes a tapered receptor opening148for reception of a tapered stem structure114. A rib156is formed on the cartridge62, and a plurality of ribs164are formed on the stem106, cooperate to provide tactile notification to a patient-user that measured doses of the cream have been administered.

Description

This application is a continuation of U.S. application Ser. No. 10/160,166, filed Jun. 4, 2002, which was on the filing date of this continuation application, and which issued on Nov. 28, 2006, as U.S. Pat. No. 7,141,036, and is incorporated herein by reference thereto.

BACKGROUND OF THE INVENTION

This invention relates to an applicator for dispensing a medicinal substance, and particularly relates to an applicator for providing a delivery passage for a medicinal substance.

Various medical conditions, which are located within the vaginal and/or anal openings of the human anatomy, can be treated with medicinal creams and other substances of similar consistency. Frequently, such creams are prescribed by physicians, and are to be applied in measured dosages over a period of time. Because of the necessity for frequent applications of the cream to the affected locations, it is beneficial and economical for the patient to self-administer the measured dosage applications.

However, it is difficult, and in some instances impossible, for the patient to view, or sense, that the proper dosage of the cream is being applied in the vaginal and anal areas. In addition, the act of administering the medicinal cream in such areas, frequently places the patient in awkward physical positions, which require a level of dexterity not inherent in some patients. Under these conditions, imprecise amounts of the cream could be administered undesirably.

In the past, several devices have been developed for storing multiple doses of the medicinal substances within a barrel of a syringe or a cartridge, to facilitate the successive application of time-spaced doses over a period of time. Such devices also include a plunger within the barrel, and a stem for engaging the plunger and urging the cream in successive doses from within the barrel, and through a dispensing means such as an applicator.

Cleanliness of such devices is unpredictable, during dispensing and during storage and transporting thereof. Thus, there is a need for a multiple-dose delivery device which can be easily cleaned while retaining the cream within the barrel, and also during storage and transporting of the device between the time-spaced administering of successive doses of the cream. Also, there is a need for a multiple-dose delivery device which can be dismantled easily for effective cleaning, and for storage and portability.

Other devices developed in the past have included some means for tactile notice to the patient that the appropriate dose has been dispensed. While devices of this type have provided a useful purpose, such devices tend to be complex, costly and, at times, unwieldy. Frequently, the tactile systems of such devices make it difficult, if not impossible, to dismantle the components of the device for cleaning, storage and transporting.

Thus, there is a need for a multiple-dose delivery device which includes an effective tactile system, which is uncomplicated, inexpensive and facilitates the ready dismantling of the components of the device.

Devices developed in the past facilitate the dispensing of the cream generally within the vaginal and/or anal openings, but tend not provide structure which focuses the cream directly onto the critical areas for a most effective treatment.

Thus, there is a need for a multiple-dose delivery device, and an applicator thereof, which focuses the cream directly onto the critical areas to be treated.

SUMMARY OF THE INVENTION

It is, therefore, an object of this invention to provide a focused dosimetry device, which can be easily cleaned while retaining the cream in the cartridge barrel.

Another object of this invention is to provide a focused dosimetry device which can be easily dismantled for effective cleaning, storage and portability.

A further object of this invention is to provide a focused dosimetry device which includes an effective tactile system to inform the patient-user of the accurate dispensing of a prescribed dose of the cream.

An additional object of this invention is to provide a focused dosimetry device with an applicator, and an applicator independently of the device, which focuses the dispensed cream directly onto the critical areas to be treated.

With these and other objects in mind, this invention contemplates a focused dosimetry device which includes a cartridge with a barrel having a passage therethrough between a proximal end thereof and an axially spaced distal end thereof. A plunger head is locatable and movable within the passage of the barrel, and has a compliant section facing the distal end of the barrel and a receptor section facing the proximal end of the barrel. The receptor section is comparatively more rigid than the compliant section. A receptor opening is formed in a proximal end of the receptor section of the plunger head and has a prescribed configuration.

A stem having a stem structure at a proximal end thereof is generally complementary to the prescribed configuration of, and is insertable into, the opening of the receptor. The prescribed configuration is structured to create a piloted engagement of the stem structure within the receptor opening and to preclude a taper-lock interference fit therebetween.

This invention also contemplates a focused dosimetry device, which includes means, located at the distal end of the barrel, for directing a substance from within the barrel to a location outside of the barrel upon movement of the stem toward the distal end of the barrel.

In addition, this invention contemplates a focused dosimetry device which includes a cartridge assembly formed with a barrel having a passage therethrough between a proximal end thereof and an axially spaced distal end thereof. A first tactile structure is located on the cartridge assembly adjacent the proximal end of thereof, and a compliant plunger is locatable and movable within the passage of the barrel. A stem having a distal end is positionable within the barrel to facilitate movement of the plunger within the barrel.

A plurality of second tactile structures are located spatially on the stem in a position to engage successively the first tactile structure on the cartridge assembly as the stem is moved into the barrel to provide tactile notification of delivery of measured amounts of a substance from within the barrel.

Further, this invention contemplates a focused dosimetry device, which includes an applicator attached to a distal end of a cartridge of the device and has a body which is formed with an axial passage in communication with the barrel of the cartridge. The axial passage of the applicator extends from a proximal end of the body toward a closed distal end thereof. A plurality of elongated slots are formed spatially and radially through the body in communication with the axial passage and an exterior of the body.

Still further, this invention contemplates an applicator for dispensing a substance therethrough, which includes a body formed with an axial passage having an entry opening at a proximal end of the body for receiving the substance to be dispensed. The axial passage of the applicator extends from the proximal end of the body toward a closed distal end thereof. A plurality of elongated slots are formed spatially, with respect to each other, and radially through the body in communication with the axial passage and an exterior of the body. Each of the elongated slots is formed with a corresponding elongated outlet, for passing the substance from the entry opening, through the axial passage, the plurality of elongated slots, and the respective elongated outlets to the exterior of the body. The applicator may also include a wiper for disbursing and spreading the cream about the critical area to be treated, and also a tactile flange having a concave frustoconical surface for a comfortable indication of the proper depth of insertion of the applicator.

Additionally, this invention contemplates a focused dosimetry device, which includes a cartridge formed with a barrel having a passage therethrough between a proximal end thereof and an axially spaced distal end thereof. The cartridge has an exterior shape of a prescribed configuration. A plunger head is locatable and movable within the passage of the barrel. A stem has a distal end positionable within the barrel to facilitate movement of the plunger within the barrel A carrier formed with a cartridge-receiving nest has a shell-like opening which is generally complementary to the prescribed configuration of the exterior shape of the cartridge. Means is provided for retaining the cartridge within the cartridge-receiving nest. A guide extends from a proximal end of the carrier and is formed with a passage for receiving at least an intermediate portion of the stem for sliding movement of the intermediate portion therein. Means is provided for precluding removal of the distal end of the stem from within the carrier.

Also, this invention contemplates a focused dosimetry device and case for storing and for portability of the components of the device when not in use.

Other objects, features and advantages of the present invention will become more fully apparent from the following detailed description of the preferred embodiment, the appended claims and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings:

FIG. 1 is a partially-sectioned side view showing a first embodiment of a focused dosimetry device, in accordance with certain principles of the invention;

FIG. 2 is an exploded side view showing components of the focused dosimetry device ofFIG. 1, including a first embodiment of an applicator, and a first embodiment of a cap, all in accordance with certain principles of the invention;

FIG. 3 is a sectional side view showing a second embodiment of an applicator, in accordance with certain principles of the invention;

FIG. 4 is a sectional view taken along lines4-4 ofFIG. 3 showing internal details of the second embodiment of the applicator ofFIGS. 3, in accordance with certain principles of the invention;

FIG. 5 is a sectional view showing a third embodiment of an applicator, in accordance with certain principles of the invention;

FIG. 6 is a sectional view taken along line6-6 ofFIG. 5 showing the third embodiment of the applicator ofFIG. 5, in accordance with certain principles of the invention;

FIG. 7 is a perspective view showing the cap ofFIG. 2 for assembly with the focused dosimetry device ofFIG. 2, and other embodiments of focused dosimetry devices described herein, in accordance with certain principles of the invention;

FIG. 8 is an exploded view showing a plunger head, with a plunger, or plunger section, and a receptor section, and further shows a distal end of a stem, all of the focused dosimetry device ofFIGS. 1 and 2, in accordance with certain principles of the invention;

FIG. 9 is a partial sectional view showing the assembly of the plunger, the receptor section and the distal end of the stem ofFIG. 8 located within the proximal end of a cartridge syringe barrel of the focused dosimetry device ofFIG. 1 and2, in accordance with certain principles of the invention;

FIG. 10 is a partial sectional view showing a first embodiment of a tactile registration system for facilitating measured relative movement between the stem and the cartridge barrel ofFIG. 2 of the focused dosimetry device ofFIGS. 1 and 2, in accordance with certain principles of the invention;

FIG. 11 is a partial sectional view showing a second embodiment of a tactile registration system for facilitating measured relative movement between the stem and the cartridge barrel ofFIG. 2 of the focused dosimetry device ofFIGS. 1 and 2, in accordance with certain principles of the invention;

FIG. 12 is a top view showing disassembled components of the focused dosimetry device ofFIGS. 1 and 2 stored within complementarily shaped nests of a case for storage of the components when the device is not in use, in accordance with certain principles of the invention;

FIG. 13 is a sectional side view showing a second embodiment of a focused dosimetry device, including a carrier, in accordance with certain principles of the invention;

FIG. 14 is a sectional side view showing assembled components of the carrier ofFIG. 13 in position for receiving a cartridge in accordance with certain principles of the invention;

FIG. 15 is a partial sectional view showing various components of the focused dosimetry device ofFIG. 13 in assembly, in accordance with certain principles of the invention;

FIG. 16 is an end view showing the cartridge ofFIG. 14 in assembly with the carrier of the focused dosimetry device ofFIG. 13, in accordance with certain principles of the invention;

FIG. 17 is a top view showing disassembled components of the focused dosimetry device ofFIG. 13 stored within complementarily shaped nests of one compartment of a two-compartment case for storage of the components when the device is not in use, and a plurality of the cartridges ofFIG. 14 stored within complementarily shaped nests, in accordance with certain principles of the invention;

FIG. 18 is a partially-sectioned side view showing a third embodiment of a focused dosimetry device, in accordance with certain principles of the invention;

FIG. 19 is a partially-sectioned side view showing various components of the focused dosimetry device ofFIG. 18 in assembly, in accordance with certain principles of the invention;

FIG. 20 is a sectional view showing a first guide and a second guide which form components of the focused dosimetry device ofFIG. 18, in accordance with certain principles of the invention;

FIG. 21 is a side view showing a fourth embodiment of a focused dosimetry device, including a carrier, tactile structures and a finger rest, in accordance with certain principles of the invention;

FIG. 22 is a sectional side view showing the finger rest for optional assembly with the focused dosimetry device ofFIG. 21, in accordance with certain principles of the invention;

FIG. 23 is a sectional view showing various components of the focused dosimetry device ofFIG. 21 in assembly, in accordance with certain principles of the invention;

FIG. 24 is a sectional side view showing components of the focused dosimetry device ofFIG. 21, including the carrier and a stem, in an assembled condition for storage of the device, in accordance with certain principles of the invention;

FIG. 25 is a side view showing a fifth embodiment of a focused dosimetry device, in accordance with certain principles of the invention;

FIG. 26 is a side view of a cover for use with the focused dosimetry device ofFIG. 25, in accordance with certain principles of the invention;

FIG. 27 is a top view showing disassembled components of the focused dosimetry device ofFIG. 25 stored within complementarily shaped nests of a case for storage of the components when the device is not in use, in accordance with certain principles of the invention;

FIG. 28 is a partially-sectioned side view showing a sixth embodiment of a focused dosimetry device, in accordance with certain principles of the invention;

FIG. 29 is a partially-sectioned side view showing a seventh embodiment of a focused dosimetry device, in accordance with certain principles of the invention;

FIG. 30 is a partially-sectioned side view showing an eighth embodiment of a focused dosimetry device, in accordance with certain principles of the invention;

FIG. 31 is a partially-sectioned side view showing a ninth embodiment of a focused dosimetry device, including a cartridge nested in a carrier having spaced slots for receiving a flange of the cartridge, in accordance with certain principles of the invention;

FIG. 32 is a side view showing an assembly of the cartridge and carrier of the focused dosimetry device ofFIG. 31, in accordance with certain principles of the invention;

FIG. 33 is a partial section view taken along line33-33 ofFIG. 31 showing the flange of the cartridge ofFIG. 31 nested in a respective one of the flange-receiving slots of the carrier, in accordance with certain principles of the invention;

FIG. 34 is a partial section view taken along line34-34 ofFIG. 31 showing the cartridge ofFIG. 31 nested in a cartridge-receiving nest of the carrier ofFIG. 31, in accordance with certain principles of the invention;

FIG. 35 is a partially-sectioned side view showing a tenth embodiment of a focused dosimetry device for use with two stems, in accordance with certain principles of the invention;

FIG. 36 is a top view showing disassembled components of the focused dosimetry device ofFIG. 25, including two stems of different lengths, stored within complementarily shaped nests of a case for storage of the components when the device is not in use, in accordance with certain principles of the invention;

FIG. 37 is a section view showing a second embodiment of a cap for assembly with the focused dosimetry device ofFIG. 35, and other embodiments of focused dosimetry devices described herein, in accordance with certain principles of the invention;

FIG. 38 is a partial section view of a focused dosimetry device of the type shown inFIG. 35, showing an initial volume of a substance within a portion of a cartridge and a plunger head positioned at a prescribed location, in accordance with certain principles of the invention;

FIG. 39 is a partial section view of the focused dosimetry device of the type shown inFIGS. 35 and 38, showing a first stem of a prescribed length having moved the plunger head to an intermediate location, in accordance with certain principles of the invention;

FIG. 40 is a partial section view of the focused dosimetry device of the type shown inFIGS. 35, 38 and39 showing a second stem of a length greater than the prescribed length having moved the plunger head to an final location, in accordance with certain principles of the invention;

FIG. 41 is a section view of a separated barrel of a cartridge and plunger head;

FIG. 42 is a section view showing the cartridge barrel ofFIG. 41, with the plunger head assembled within, and located at a distal end of, the barrel, in accordance with certain principles of the invention;

FIG. 43 is a partial section view showing a substance loading device in assembly with the distal end of the cartridge barrel ofFIG. 41 with the plunger head being urged away from the distal end of the barrel by the substance being deposited into the barrel, in accordance with certain principles of the invention;

FIG. 44 is a section view showing a substance-loaded cartridge barrel with a cap on the distal end thereof, in accordance with certain principles of the invention;

FIG. 45 is a section view showing an applicator assembled on the distal end of the cartridge barrel and a stem moving the plunger head to dispense the substance from within the barrel;

FIG. 46 is a section view showing a substance loading device having loaded the substance into the cartridge barrel and urging the plunger head into a stop surface formed by the distal end of a guide mounted in the proximal end of the cartridge barrel;

FIG. 47 is a section view of an applicator in assembly with the distal end of the cartridge barrel, and with a stem in position to move the plunger head to dispense the barrel-contained substance into and through the applicator; and

FIG. 48 is a section view of an applicator showing serially-arranged, integrally-joined sections of the applicator extending from a proximal end to a closed distal end thereof in accordance with certain principles of the invention.

DETAILED DESCRIPTION OF THE INVENTION

In the embodiments of the focused dosimetry devices as described below, a substance, such as medicinal cream, compound, or the like, is deposited into a barrel of a cartridge of the device. The volume of the cream deposited in the cartridges of the respective embodiments represents a single dose or multiple doses, depending on the particular embodiment being used or described. With respect to the devices which contain multiple doses of the cream, several single doses can be administered successively therefrom over a period of time, and the components of the multiple dose devices can be disassembled, cleaned, stored and/or transported, if desired or necessary, during periods when the device is not being used.

The consistency of the cream is such that the cream does not flow easily within or out of the cartridge without a force being applied to the barrel-confined mass thereof. Typically then, a plunger head within the barrel is urged by pushing a stem, which is in contact with the head, to force the cream to exit the barrel.

The focused dosimetry devices described below are particularly useful for applying and focusing each administered dose of cream to affected areas of vaginal and anal openings of the human anatomy. The devices, or portions thereof, may be useful for other purposes without departing from the spirit and scope of the invention.

Each below-described focused dosimetry device includes a dispensing end at which the cream is dispensed from the cartridge to the affected area of the patient. Such dispensing end of each focused dosimetry device will hereinafter be referred to as the distal end. The opposite end of each such device, which includes a stem, will be referred to as the proximal end of the device. The end of any component of each focused dosimetry device, which is closest to the distal end of the device, will be referred to as the distal end of the component, and the other end of such component, which is opposite the distal end, will be referred to as the proximal end.

Referring toFIGS. 1 and 2, a first embodiment of a focused dosimetry device is identified asdevice60, and is typically used in multiple dose applications. Thedevice60 includes acartridge62, having abarrel64, for containing a substance such as the medicinal cream, or any other substance having a cream-like consistency. Thedevice60 is a multiple dose device. However, certain principles of the invention embodied in thedevice60 could be used in a single does device.

In thedevice60, thebarrel64 is formed with a hollowinterior barrel passage66, having adistal opening68 at a distal end thereof and aproximal opening70 at proximal end thereof. A finger-rest flange72 is formed radially outward on thebarrel64 at the proximal end thereof.

A small-diameter sleeve74 forms an integral part of thecartridge62, and is in axial alignment with thebarrel64 at the distal end thereof, and forms asleeve passage76, which is in communication with thebarrel passage66. The exterior of the small-diameter sleeve74 is tapered in the form of a frustum, with the smaller diameter of the frustum located at the distal end of the sleeve, and the axis of the frustum being coincidental with the axis of thebarrel64.

A large-diameter sleeve78 also forms an integral part of thecartridge62, at the distal end thereof, and is in axial alignment with thebarrel64, and coaxial alignment with the small-diameter sleeve74. An internal cylindrical wall of the large-diameter sleeve78 is threaded, and the proximal end of the sleeve is closed and not in communication with thebarrel passage66.

Anapplicator80, or tip, which is formed with asmooth body81 having anaxial passage82 therein, is assembled with thecartridge62 at the distal end of thebarrel64, for example, by use of a known coupling facility such as the coupling facility identified with U.S. registered trademark LUER-LOC.

In particular, as shown inFIG. 2, theaxial passage82 of theapplicator80 is formed with a taperedproximal opening84 which mates with the exterior taper of thesleeve74 of thecartridge62 to facilitate one aspect of the attachment of the applicator with the cartridge. Thebody81 of theapplicator80 is formed with afirst ear86 and asecond ear88, which extend in radially opposite directions from the proximal end of the applicator. Upon assembly of theapplicator80 with thecartridge62, the outboard ends of the

ears

86 and88 are threadedly applied to, and within, the large-diameter sleeve78 by rotation of the applicator. The rotation of theapplicator80 also enhances the tapered assembly of the tapered small-diameter sleeve74 with the taperedproximal opening84 of theaxial passage82.

It is noted that facilities, other than as described above, can be used to attach theapplicator80 to thecartridge62 without departing from the spirit and scope of the invention. Such attachment facilities could be threaded, unthreaded, tapered, press fit, or the like.

As shown inFIGS. 2 and 4, theapplicator80 is further formed with aninner passage90, four axially-aligned, equally angularly spaced sets of three axially-spaced radially-orientedholes92 in each set, and four axially-elongated slot-likeouter openings94. The taperedproximal opening84, theinner passage90, theholes92 and theopenings94 of theapplicator80 are all in communication with each other to facilitate the smooth flow of the cream from thebarrel64 and through the applicator.

Theapplicator80 is formed with a roundeddistal end96 and a tactile-indicator flange98 near the proximal end thereof. The roundeddistal end96, and thesmooth applicator body81, provide a user-friendly applicator. Theflange98 provides a tactile indication to the patient that theapplicator80 has been inserted into the vaginal or anal cavity at the appropriate distance for placement of theopenings64 adjacent the areas to be treated with the cream.

Referring again toFIGS. 1 and 2, aplunger head100 includes a compliant section, also referred to as acompliant plunger102, which is locatable and movable within thepassage66 of thebarrel64. Theplunger head100 also includes areceptor section104 which is coupled to theplunger102. Theplunger head100 is assembled for sliding movement within thepassage66 of thebarrel64, between theproximal opening70 and thedistal opening68 of the barrel.

A hollowrigid stem106, which, for example, could be composed of a thermoplastic material such as polycarbonate, is formed by a secured assembly of astem member108 and athumb piece110, which is formed at the proximal end thereof with a flange-like thumb rest112. Thestem member108 is formed with astem structure114 at a closed distal end thereof, with the stem structure being in the shape of a frustum. The distal end of thestem106 is initially inserted into theproximal opening70 of thebarrel64 such that thestem structure114 engages a proximal end of thereceptor section104 of theplunger head100. This provides facility for urging theplunger head100 within thepassage66 of thebarrel64, toward the distal end thereof.

The diameter of the proximal end of thestem structure114 of thestem106 is smaller than the diameter of thestem member108, thereby forming ashoulder116 at the junction of the stem structure and the stem member. Also, ashoulder118 is formed radially on an intermediate portion of thethumb piece110, which abuts aproximal end120 of thestem member108 upon assembly of the stem member and the thumb piece, whereafter the thumb piece and the stem member are bonded together.

During periods when thedevice60 is not being used, theapplicator80 is removed from assembly with thecartridge62. A first embodiment of acap122, as shown inFIGS. 2 and 7, is attached in place of theapplicator80 to seal thedistal opening68 of thebarrel64 to prevent cream from discharging or leaking undesirably from the barrel. Thecap122 is formed with acylindrical cup124, which is formed with atapered opening126 for receipt of the tapered small-diameter sleeve74 when assembling the cap with the cartridge. A pair ofears127 are formed radially outward at the proximal end of thecup124. Aflat vane128 is formed integrally with a closed end of thecup92 to facilitate handling of thecap122 during assembly and disassembly of the cap with respect to thesleeve74. The assembly of thecartridge62 and thecap122 forms a cartridge-cap assembly129, as shown inFIG. 12.

Referring now toFIGS. 8 and 9, theplunger102 is formed from a compliant or elastomeric material such as, for example, butyl rubber or buna rubber. Theplunger102 is formed with an outerperipheral surface130 having a diameter which is sized to fit within thepassage66 of thebarrel64, to allow sliding axial movement of the plunger within the passage. The cream is typically stored within a storing portion of thepassage66 between adistal end132 of theplunger102 and the distal end of the passage. The sliding fit of theplunger102 within thepassage66 will also preclude the flow of cream from the storing portion of the passage, past the plunger and toward the proximal end of thebarrel64.

Thedistal end132 of theplunger102 is formed with a shallow taper to an axial point thereof pointing toward the distal end of thebarrel64. Aproximal end134 of theplunger102 is formed with anopening136, of a first diameter, which communicates with a comparativelylarger cavity138, of a second diameter. Thecavity138 is formed axially farther within theplunger102 toward thedistal end132 thereof, where the second diameter is greater than the first diameter. Thecavity138 is formed with aflat floor140, with an axiallyshort side wall142, which is contiguous with the floor, and is angled radially outward and toward theproximal end134 of theplunger102. Thecavity138 is formed with an axiallylonger side wall144, which is contiguous with theshort side wall142, and is angled radially inward and toward theproximal end134 of theplunger102.

Thereceptor section104 of theplunger head100 is composed, for example, of a thermoplastic material such as acetal, and is rigid in comparison to thecompliant plunger102. Thereceptor section104 is formed with astructure146 which is complementary with the hollow structure of the combined profile of theopening136 and thecavity138 to facilitate coupling assembly of the receptor section with the plunger to form theplunger head100 as illustrated inFIG. 9.

Areceptor opening148 is formed in aproximal end150 of thereceptor section104 of theplunger head100 and is formed with a prescribed configuration. In particular, with reference toFIG. 8, thereceptor opening148 is formed with a tapered side wall at a taper angle “a,” and at a depth of “x” to afloor152. Thestem structure114 of thestem106 is formed in a configuration similar to the prescribed configuration of thereceptor opening148, the only difference being that the stem structure extends for a distance “y” from the stem member, which is less than the depth “x” of the receptor opening. Because of the difference in the depth “x” and the distance “y,” the distal end of thestem structure114 does not engage thefloor152 of thereceptor opening148 when the stem structure is assembled fully within the receptor opening, as shown inFIG. 9. This allows thestem structure114 to fully seat within thereceptor opening148 without interfering engagement between thefloor152 of thereceptor opening148 and the distal end of thestem structure114.

When thestem structure114 is being assembled with theplunger head100, the matching taper of the stem structure and thereceptor opening148 facilitates a piloting engagement thereof. During this process, thestem structure114 and thereceptor opening148 cooperate quickly to locate the optimum interfacing engagement thereof in preparation for the application of a force to thestem106 to move theplunger head100 toward the distal end of thebarrel64.

When engaging surfaces of two objects having the same taper are moved axially together, the angle of such taper plays a part in the manner in which the surfaces interface with each other. Based, to some extent, on the materials of the two objects in the area of the interfacing surfaces, there is a critical angle of taper below which the interfacing surfaces engage with a taper-lock interference fit. In order to release the two objects from such an interference fit, considerable force must be used to pull the objects apart, which tends to disturb the location of both objects. If the taper is above the critical angle, the interfacing surfaces do not engage in a taper-lock interference fit, and a first of the objects can be moved easily away from a second of the objects without disturbing the location of the second object.

The critical taper angle consideration is important in the operation of themultiple dose device60, and other multiple dose embodiments described herein, because, in multiple dose situations, thestem106 is removed from assembly with theplunger head100 following the application of each dose. It is important that theplunger head100 remain in its end-of-dose position after each dose is administered so that the plunger head will be in the appropriate position for the initiation of the next dose to be administered. If there had been a taper-lock interference fit between thestem structure114 and the wall of thereceptor opening148, considerable force would have been required to separate the stem structure from within the receptor opening, which would have resulted in undesirable movement of theplunger head100. This is particularly so with respect to thedevice60, and other multiple dose embodiments described herein, because there is no way to grasp and hold steady theplunger head100 while removing thestem106. Also, theplunger head100 is, in essence, floating in a lubricated environment provided by the cream contained within thebarrel64, which would tend to ease and enhance the undesirable movement of the plunger head when thestem106 being removed.

Based on the above described structure of thedevice60, the prescribed configuration of the taper angle “a” is structured to create a piloted engagement of thestem structure114 within thereceptor opening148 and to preclude a taper-lock interference fit.

Referring toFIG. 10, theproximal opening70 of thebarrel64 is formed with a funnel-shapedsurface154 which extends radially inward and toward the distal end of the barrel. An internalannular rib156, which is a first tactile structure located on thecartridge62 adjacent the proximal end thereof, is formed at a juncture of thesurface154 and the wall surface of thepassage66 of thebarrel64. Therib156 is formed with aradial surface158 and asloping surface160 which join at a pointed edge162.

A plurality ofannular ribs164, which are a plurality of second tactile structures, are located spatially on thestem106 in position to engage therib156, that is, the first tactile structure, of thecartridge62 as the stem is moved into thebarrel64 to provide delivery of measured amounts of the substance from within the barrel. A slightannular depression166 is formed on the distal side of each of the plurality ofannular ribs164 for accommodation of the pointed edge162.

The spacing between each adjacent pair of the plurality ofannular ribs164 correlates to the dispensing of a single dose of the multiple doses of cream initially contained within thecartridge62. As one of the plurality ofribs164 moves into engagement with therib156, the opposition to continued movement of thestem106 is sensed by the patient-user as a tactile response to indicate that the dispensing of a single dose of the cream has been completed. The opposition to movement of thestem106, presented by the engagement by one of theribs164 with therib156, is easily overcome, when the next single dose is to be dispensed, but clearly serves as tactile notification to the patient-user that each successive single dose has been administered.

Referring toFIG. 11, another embodiment of a tactile system includes structure similar to the structure illustrated inFIG. 10. In particular, inFIG. 11, the orientation of the rib156 (FIG. 10) has been reversed to form arib156awith asloping surface160abeing a continuation of a funnel-shapedsurface154a. Aradial surface158ais formed between apointed edge162aand the wall surface of thepassage66. The structure of thestem106 and the plurality ofribs164, in the embodiment ofFIG. 11, is unchanged.

In operation of themultiple dose device60, thecartridge62, with the appropriate multiple dose volume of cream, is delivered to the patient-user. Thedevice60 is delivered with thecap122 attached to the distal end of thecartridge62, and with theplunger head100 located at the proximal end of the cream within the cartridge. In this condition, the cream is captured between the capped distal end of thecartridge62 and the distal end of theplunger head100, and cannot escape.

When the patient-user is preparing to administer the first of the multiple doses contained in thecartridge62, thecap122 is removed and theapplicator80 is attached to the distal end of the cartridge. The distal end of thestem106 is then inserted into thepassage66 of thebarrel64 at the proximal end thereof, and thestem structure114 is moved into thereceptor opening148 to seat the stem structure in the opening, in the manner described above. The patient-user then places theapplicator80 into the body opening to be treated. The patient-user senses the initial insertion of theflange98 into the cavity as tactile notification that theapplicator80 is in the appropriate location for administering the cream. The patient-user pushes thestem106 toward the distal end of thecartridge62, whereby the first dose of cream is dispensed from theapplicator80 onto the area to be treated.

Eventually, tactile notification is sensed by the patient-user when one of theribs164 of thestem106 engages therib156 of thecartridge62, in the manner described above. Theapplicator80 is then removed from the cavity. During the dispensing of the first dose of the cream, theplunger head100 has been moved to a position at which the dispensing of the second dose will begin.

Thestem106 is removed, with ease as described above, without disturbing the position of theplunger head100. Theapplicator80 is removed from the distal end of thecartridge62. All of the separated components can be cleaned, if needed or desired. Thecap122 is attached to the distal end of thecartridge62, which forms the cartridge-cap assembly129 having a prescribed cartridge-cap profile. Also, an exterior of thestem106 has a prescribed stem profile, and an exterior of theapplicator80 has a prescribed applicator profile.

Referring toFIG. 12, acase168 includes afirst compartment172 with abase surface174, and asecond compartment176. Thebase surface174 of thefirst compartment172 is formed with a plurality of

nests

177,178 and179 in configurations of any one, or more, of the prescribed cartridge-cap profile, the prescribed stem profile and the prescribed applicator profile, respectively. Thefirst compartment172 is coupled to thesecond compartment176 by

hinges

180 and182 along

adjacent edges

184 and186, respectively, of the first and second compartments. Thecase168 is integrally formed by a plastic molding process, whereby the

hinges

180 and182 are formed integrally with thefirst compartment172 and thesecond compartment176, respectively.

Alatch arrangement188 includes afirst element190, which is formed on afirst edge192 of thefirst compartment172, and asecond element194, which is formed on asecond edge196, opposed to thefirst edge192, of thesecond compartment176. Thefirst element190 is formed with anopening198, and thesecond element194 is formed with alatch projection200, which snaps into theopening198 to latch thefirst compartment172 with thesecond compartment176 when the first and second compartments are moved in closing engagement about the

hinges

180 and182. Thelatch projection200 is formed with a camming surface, which cams the projection through theopening198, and a shelf, which snaps under thefirst element190 adjacent theopening198 to latch thefirst compartment172 with thesecond compartment176.

Thus, this structure forms thelatch arrangement188 which is located on opposing

edges

192 and196 of the first and

second compartments

172 and176, respectively, for coupling engagement when the first and second compartments are closed on each other.

After separating theapplicator80 and thestem106 from thecartridge62, and after placing thecap122 onto the distal end of the cartridge, the patient-user places the cartridge-cap assembly129, the stem and the applicator into their

respective nests

177,178 and179, respectively, of thecase168. Thesecond compartment176 is then closed over thefirst compartment172, and latched in a closed position by thelatch arrangement188.

The patient-user can then store thecase168 in a convenient location, or transport or carry the case with them, in anticipation of the next single dose to be administered.

With respect to the descriptions below of other embodiments of the focused dosimetry devices, including the applicators and the cases, the description of preceding embodiments will not be repeated where the components of such later-described embodiments are identical to the described components of the preceding embodiments. Also, the numerals used in a preceding description will be used in the later description to identify the identical components.

Referring toFIGS. 3 and 4, a second embodiment of an applicator, identified asapplicator80a, is formed with four equally, angularly and axially-elongated throughslots202 in place of theholes62 of theapplicator80. Otherwise, theapplicator80ais identical to theapplicator80, and is assembled with thecartridge62 in the same manner described above with respect to theapplicator80. The axially-elongated throughslots202 of theapplicator80aprovide a faster and more widespread application of the cream to the affected area to be treated in comparison to the delivery through theholes92 of theapplicator80.

Referring toFIGS. 5 and 6, a third embodiment of an applicator, identified asapplicator80b, and which is the preferred embodiment, is similar to theapplicator80. For example, each of the

applicators

80 and80bis formed with thesmooth body81 having theaxial passage82 therein, and is to be assembled with thecartridge62 at the distal end of thebarrel64. Also, theapplicator80bis formed with theaxial passage82, with a taperedproximal opening84, which mates with the exterior taper of thesleeve74 of thecartridge62 to facilitate one aspect of the attachment of the applicator with the cartridge. Thebody81 of theapplicator80bis formed with thefirst ear86 and thesecond ear88, which extend in radially opposite directions from the proximal end of the applicator, to facilitate assembly of theapplicator80bwith thecartridge62 in the manner described above with respect to theapplicator80.

In addition, thebody81 of theapplicator80bis formed with the two diametrically-opposed axially-elongated throughslots204, which, individually, are identical to the throughslots202 of theapplicator80a. Theapplicator80bis also formed with two

wipers

206 and208 which extend radially outward from diametrically opposite sides of thebody81 of theapplicator80b, and which extend axially and parallel to the throughslots204. The throughslots204 and the two

wipers

206 and208 are equally angularly spaced about the axis of thebody81, as shown inFIG. 4. Each of the two

wipers

206 and208 extend radially outward from thebody81 in the shape of a convex mound.

A first pair of

ramps

210 and212 are formed with, and extend axially in opposite directions from, opposite ends of thewiper206, and extend from aradially outwardmost surface214 of the wiper to respectiveadjacent surface portions216 of thebody81. A second pair of

ramps

218 and220 are formed with, and extend axially in opposite directions from, opposite ends of thewiper208, and extend from aradially outwardmost surface222 of the wiper to respectiveadjacent surface portions224 of thebody81.

Theapplicator80bis also formed with a tactile-indicator flange226 which functions in similar fashion as theflange98 of theapplicator80, as described above. A distal side of theflange226 of theapplicator80bis formed with astraight portion228, which extends toward the axis of the applicator and toward the distal end thereof. A shallowconcave portion230 of theflange226 extends between thestraight portion228 and the outer surface of thebody81.

When a patient-user uses theapplicator80b, thebody81 is inserted into the vaginal or anal opening of the patient until the patient tactility senses engagement with theflange226, in the manner noted above with respect to the use of theapplicator80. With the combinedstraight portion228 and theconcave portion230 on the distal side of theflange226, a gentile and gradual engagement of the flange with the patient is accomplished to avoid discomfort to the patient during the process.

In the same manner noted above with respect to theapplicator80a, the axially-elongated throughslots202 of theapplicator80bprovide a faster and more widespread application of the cream to the affected area to be treated. After the cream has been applied within the vaginal or anal opening, thefocused dosimetry device60, including theapplicator80b, can be rotated and/or oscillated about the applicator axis. With such action, the

wipers

206 and208 of theapplicator80bengage the deposited cream, and spread the cream about, and wipe the cream into, the affected area, to provide an effective application of the cream.

As the patient inserts theapplicator80binto, or removes the applicator from, the vaginal or anal openings, the

ramps

210,212,218 and220 provide a comfortable transition for those areas of the patient which must transition from the smooth outer surface of thebody81 to the outwardmost surfaces214 and222 of the

wipers

206 and208, respectively. If the

ramps

210,212,218 and220 were not present, the patient would sense an abrupt and uncomfortable reaction to engagement with the ends of the

wipers

206 and208.

While theapplicator80bis the preferred embodiment, any of the three

applicators

80,80aand80bcan be used with thecartridge62, as well as other cartridges described below, without departing from the spirit and scope of the invention. Further, any of the three

applicators

80,80aand80bform a means located at the distal end of thebarrel64 for directing a substance from within the barrel to a location outside of the barrel upon movement of thestem106 toward the distal end of the barrel.

Referring toFIGS. 13, 14 and15, a second embodiment of a focused dosimetry device, identified asdevice232, is typically used in multiple dose applications. Thedevice232 includes acartridge233, theapplicator80 and thestem106. Thecartridge233 is similar to thecartridge62, but is not formed with a finger-rest flange72 at the proximal end thereof. Theplunger head100 is contained within abarrel235 of thecartridge233, and thestem106 is formed with thestem structure114, which is in complementary assembly within thereceptor opening148 in the manner described above.

Referring particularly toFIG. 14, acarrier234 is formed with a cartridge-receivingnest236 having a shell-like opening which is generally complementary to the prescribed configuration of the exterior shape of the cartridge. As shown inFIG. 16, thenest236 is formed in a C-shaped configuration having

end portions

238 and240, which extend past avertical centerline242. Thecartridge233 is shown in thenest236, with the

end portions

238 and240 slightly about adjacent portions of the cartridge by a distance “b,” to provide a means for retaining thecartridge233 within the cartridge-receivingnest236, which can be overcome only by an external force applied to the cartridge.

Referring again toFIG. 14, a distal end of thenest236 is formed with a steppedwall244 which is complementary to the axial structural profile of the distal end of thecartridge233. The steppedwall244 precludes thecartridge233 from moving forward of the distal end of thecarrier234 when the cartridge is seated within thenest236.

Aguide246 is formed with an enlargedcylindrical section248 extending over approximately a proximal one-half of the axial length thereof, and a reducedcylindrical section250 which extends approximately a distal one-half of the axial length of the guide. In addition, theguide246 is formed with anaxial passage252 which ultimately receives at least an intermediate portion of thesleeve106 for sliding movement of the intermediate portion therein. Theaxial passage252 includes apassage chamber254 at the distal end thereof.

Theguide246 is also formed with a radiallyoutward shoulder256 which abuts a distal end of thecarrier234 upon assembly therewith, and a radiallyinward shoulder258, which abuts ashoulder260 formed at the proximal end of thestem structure114 of thestem106, when the stem is moved to its farthest proximal location.

Prior to forming thedevice232, thecarrier234, theguide246, thestem106, and thethumb piece110 are in an unassembled state. The proximal end of thestem106 is inserted into thepassage chamber254 of theguide246, at the distal end thereof, and through theaxial passage252 until thestem shoulder260 abuts theinward shoulder258 of the guide. Thethumb piece110 is assembled within the proximal end of thestem106, and is secured in that position, by bonding, gluing or any suitable process. The reducedcylindrical section250 of theguide246 is inserted into the opening of thecarrier234 at the proximal end thereof, and is secured in that position.

As shown inFIG. 14, thecarrier234, theguide246 and thestem106 are now in assembly, with the stem being slidable within theaxial passage252, but otherwise captured with the carrier and the guide. Thestem106 can be pulled in a proximal direction until thestem shoulder260 engages theinward shoulder258 of theguide246, thereby providing a means for precluding removal of the distal end of the stem from within thecarrier234. Also, thestem106 can be moved in a distal direction until the underside of thethumb rest112 engages a proximal end of theguide246.

As shown particularly inFIG. 15, an internal annular rib262, which is a first tactile structure, is formed on theguide246 and extends radially inward thereof within theaxial passage252. A plurality ofannular grooves264, which are a plurality of second tactile structures, are located spatially axially on thestem106 in position to engage the rib262, that is, the first tactile structure of theguide246, as the stem is moved intobarrel64 to provide delivery of measured amounts of the substance from within the barrel.

The spacing between each adjacent pair of the plurality ofannular grooves264 correlates to the dispensing of a single dose of the multiple doses of cream initially contained within thecartridge233. As one of the plurality ofgrooves264 moves into engagement with the rib262, the opposition to continued movement of thestem106 is sensed by the patient-user as a tactile response to indicate that the dispensing of a single dose of the cream has been completed. The opposition to movement of thestem106, presented by the engagement by the rib262 with one of thegrooves264, is easily overcome, when the next single dose is to be dispensed, but clearly serves as tactile notification to the patient-user that each successive single dose has been administered.

When thefocused dosimetry device232 is to be used, the patient-user insures that thestem106 is fully positioned in the proximal direction as shown inFIG. 14. Thecap122 is removed from the distal end of thecartridge233, and theapplicator80 is attached to the distal end of the cartridge as described above. Thecartridge233 is then inserted into thenest236 of thecarrier232, and snapped into place in the nest by virtue of the circumferentially

extended end portions

238 and240 of the carrier. Thedevice232 is now in condition to be used.

The patient-user places theapplicator80 within the vaginal or anal opening and pushes thestem106 in the distal direction. Eventually, the rib262 engages next one of theannular grooves264 to provide tactile indication that one measured dose of the cream has been delivered.

Theapplicator80 is removed from the patient-user and thestem106 is then moved fully in the proximal direction, as shown inFIG. 14, and thecartridge233 is removed from thenest236. Theapplicator80 is detached from the distal end of thecartridge233, and thecap122 is attached in place of the applicator.

After cleaning, the patient-user then places the disassembled components of thedevice232 into respective nests of acase266, shown inFIG. 17. It is noted that the formation of the nests of thecase266 are complementary to the profiles of the various components stored therein, in the same manner as in the above-described case168 (FIG. 12). Further, thesecond compartment176 of thecase266 is formed with abase surface268 in which a plurality ofnests270 are formed for receipt of a plurality of cartridge-cap assemblies129.

In this manner, the cappedcartridge233, which is being used during an extended period for dispensing the multiple doses, is stored in thefirst compartment172, along with theapplicator80 and the assembly of thecarrier234 and thestem106. At the same time, a supply of filled cartridge-cap assemblies129 is stored in the second compartment. This arrangement allows the patient-user to carry thecase266 for ready access of the additional, filled cartridge-cap assemblies129, when the cream of theinitial cartridge233 has been dispensed.

Referring toFIGS. 18, 19 and20, a third embodiment of a focused dosimetry device, identified asdevice268, is similar to thedevice60 as shown inFIGS. 1 and 2, and is typically used in multiple dose applications. The differences reside in astem270, which is solid as compared to the two-piecehollow stem106 of thedevice60, and that thestem270 slides through apassage272 formed by an axially-alignedfirst guide274 and asecond guide276. In particular, thefirst guide274 is located within, and extends slightly in a proximal direction from, the proximal end of thecartridge62. Aflange278 is formed at the proximal end of thefirst guide274, and is in engagement with the finger-rest flange72 of thecartridge62. Thesecond guide276 is located within anopening280 formed in a proximal end of thefirst guide274, where the distal end of the second guide does not seat fully within theopening280 to provide agap282 between interfacing portions thereof. Thesecond guide276 is also formed with aflange283 having a proximal end, which seats fully within theopening280, and which is flush with the proximal end of theflange278 of the first guide. The flush proximal ends of thefirst guide274 and thesecond guide276 form a stop surface for afinger rest285 of thestem270.

A split, metal O-ring284, as clearly shown inFIG. 20, is located within thegap282 and is formed with a separation or split286 therethrough. A continuousinward surface288 of the O-ring284 extends into thepassage272 formed by thefirst guide274 and thesecond guide276 and forms a first tactile structure in the path of a pluralityannular grooves289 formed on thestem270 as second tactile structures. As thestem270 is moved in the distal direction, as viewed inFIG. 18, the O-ring284 expands about the outer surface of the stem until one of the plurality ofgrooves289 moves into the plane of the O-ring, whereby the O-ring contracts. The contraction of the O-ring284 into one of thegrooves289 provides a tactile indication to the patient-user that one dose of themultiple dose device268 has been delivered. An O-ring composed of a non-metallic compliant material, without a split, could be used in place of the split, metal O-ring284 without departing from the spirit and scope of the invention.

Referring toFIGS. 21, 22,23 and24, a fourth embodiment of a focused dosimetry device, identified asdevice290, is similar to thedevice232 as shown inFIGS. 13, 14 and15, and is typically used in multiple dose applications. Some of the differences reside in the structural relationship between afirst guide292 and asecond guide294, which are in an arrangement similar to the arrangement of thefirst guide274 and thesecond guide276 of the device268 (FIGS. 18, 19 and20). Thefirst guide292 is assembled in, and with, the proximal end of thecarrier234 essentially in the same manner as the assembly of the guide246 (FIG. 14) with the carrier. Thesecond guide294 is assembled with, and partially in anopening296 of, thefirst guide292, with the outer surfaces of thecarrier234, the first guide and the second guide being flush.

Astem298 of thedevice290 is nearly solid, and includes thestem structure114 with theshoulder260, as shown inFIG. 14, athumb piece300 withthumb rest302, and a plurality of spacedannular grooves304 on the outer surface thereof. The O-ring284 is located between thefirst guide292 and thesecond guide294, and forms a first tactile structure, while the plurality of spacedannular grooves304 form a second tactile structure.

Afinger rest306, as shown inFIG. 22, is formed with anaxial passage308 and an undulating outer surface with a centralconcave surface310 for finger placement during administration of the cream. Thefinger rest306 is assembled with thedevice290 by moving the proximal end of the device through thepassage308 until the proximal end of the finger rest is flush with the proximal end of thesecond guide294. In this position, thefinger rest306 covers the outer flush surfaces of thefirst guide292, thesecond guide294 and a proximal portion of thecarrier234.

Thedevice290 is used in the same manner as described above with respect to thedevice232, as illustrated inFIGS. 13, 14,15 and16, with the components thereof being stored in a case in the same manner as the storage of components in the case266 (FIG. 17).

Referring toFIGS. 25, 26 and27, a fifth embodiment of a focused dosimetry device, identified asdevice312, which typically is used for multiple dose applications. Thedevice312 includes features which are identical to some of the features of thedevice268. In particular, theplunger head100, thestem270, thefirst guide274, thesecond guide276 and the O-ring284 are identical. Also, acartridge314 of thedevice312 includes a proximal portion which is identical to the proximal portion of the cartridge62 (FIGS. 18 and 19).

The differences between thecartridge62 and thecartridge314 reside in a distal portion thereof. In particular, a distal end of thecartridge314 is formed with a closed,rounded nose316. Further, a distal portion of a wall of thecartridge314 is formed with a plurality of axially-alignedholes320, which are closely spaced from each other, and which communicate with apassage322 of the cartridge.

Asleeve324, with aflange326 at the distal end of the sleeve, is secured on the outer surface of thecartridge314 on the proximal side of the proximal end of the plurality ofholes320. Theflange326 functions as a tactile indicator when the patient-user inserts thenose316 and the distal portion of thecartridge314 into the vaginal or anal opening. With this arrangement, theflange326 provides tactile indication that the plurality ofholes320 are appropriately aligned with the areas of the patient-user to be treated with the cream.

As shown inFIG. 26, ahollow cap328 is closed at a distal end thereof, and is open, and formed with a flange330, at a proximal end thereof. Thecap328 is formed to fit over thenose316 and the portion of thecartridge314 which includes the plurality ofholes320 to thereby seal the holes to prevent any leakage of cream located within thepassage322 of the cartridge. The flange330 of thecap328 is formed with anopen receptor332, with aside wall334, for receipt of the distal side and peripheral surface of theflange326, to thereby retain the cap in the position illustrated inFIG. 27. Acase334 is formed with nests for receipt of the assembly of thecartridge314 and thecap328, and thestem270, in a manner similar to the case168 (FIG. 12).

Referring toFIG. 28, a sixth embodiment of a focused dosimetry device, identified asdevice336, is typically used for a single dose application. Thedevice336 includes features which are identical to some of the features of thedevice312. The differences reside in the aplunger338, aguide340 and astem342. Theplunger338 is a single-piece component composed of a compliant material, which is mounted within thepassage322 of thecartridge314. Thepassage322 of thecartridge314 contains a single-dose volume of cream such that theplunger338 is abutting a distal end of theguide340. The distal end of thestem342 is insertable into apassage344 of theguide340, and engages and moves theplunger338 in a distal direction to move the single-dose volume of cream through theuncapped holes320. The distal end of thestem342 could be attached to the proximal end of theplunger338, rather than being insertable in and removable from thepassage344 of theguide340, without departing from the spirit and scope of the invention.

Referring toFIG. 29 a seventh embodiment of a focused dosimetry device, identified asdevice346, is typically used for a single dose application. Thedevice346 includes acartridge348 formed with apassage350, with theapplicator80 attached to the distal end of the cartridge. Afirst plunger352 is mounted freely within thepassage350 of thecartridge348, and is located at a loaded-cream position, as illustrated inFIG. 29. The loaded cream is located between the distal end of thecartridge348 and the distal end of thefirst plunger352. Ahole354 is formed through a wall of thecartridge348 on the proximal side of the proximal end of thefirst plunger352, when the first plunger is in a position associated with thepassage350 being fully loaded with the single dose of cream, as illustrated inFIG. 29.

Asecond plunger356 is mounted on a distal end of astem358, and is inserted into a proximal end of thepassage350 of thecartridge348. As thesecond plunger356 is moved within thepassage350 in the distal direction, air would tend to be entrapped within thepassage350 between the proximal end of thefirst plunger352 and the distal end of the approachingsecond plunger356. However, due the location of thehole354, the supposedly entrapped air escapes through the hole and allows thesecond plunger356 to advance unimpeded into engagement with thefirst plunger352. Upon continued movement of thestem358 in the distal direction, thefirst plunger352 is moved to the distal end of the cartridge to dispense the single dose of cream from thepassage350.

It is noted that additional holes, similar to thehole354, could be formed in the wall of thecartridge348, in a transaxial plane including thehole354, without departing from the spirit and scope of the invention. The additional holes would provide additional escape paths for any supposedly entrapped air.

Referring toFIG. 30, an eighth embodiment of a focused dosimetry device, identified asdevice360, is typically used as for multiple dose applications. Thedevice360 is similar to thedevice346, and differs in the addition of three axially-spaced

holes

362,364 and366, and three

stoppers

368,370 and372, respectively. Initially, the

stoppers

368,370 and372 are placed in the

respective holes

362,364 and366, and theplunger352 is placed on the distal side of thehole354, in a manner similar to the plunger location indevice346 with respect to thehole354. The cream is deposited within thepassage350 from the distal end of thecartridge348 to fill the space between the distal end of the cartridge and the distal end of theplunger352. The

stoppers

368,370 and372 preclude the escape of any cream from within thecartridge348.

Thesecond plunger356 of thestem358 is introduced into the proximal end of thepassage350 and moved to engagement with the proximal end of thefirst plunger352. During movement of thesecond plunger356 toward engagement with thefirst plunger352, any supposedly entrapped air will escape through thehole354, as described above with respect to thedevice346.

Upon continued movement of thesecond plunger356 in the distal direction, thefirst plunger352 is moved to dispense the initial single dose, of the multiple doses, and the first plunger is moved to the next-dose delivery position, as represented in phantom inFIG. 30. In the next-dose delivery position, thefirst plunger352 is on the distal side of the coveredhole362 in the same manner that the first plunger was on the distal side of thehole354, preceding the delivery of the initial dose of cream from thecartridge348.

At this time, thestem358 can be withdrawn, theapplicator80 can be detached and the distal end of thecartridge348 can be capped, as described above with respect to thedevice60. The disassembled components can be cleaned and stored in a case in a manner similar to the storage of components in the case168 (FIG. 12).

When it is time for the next single-dose application, the components are reassembled and thedevice360 is ready for use. Thestopper368 is removed from thehole362, and, since there is no cream at this location of the cartridge, there is no concern for leakage of cream through the now-open hole362. Thesecond plunger356 is moved into thepassage350, and through the passage to engagement with thefirst plunger352 in preparation for the delivery of the next single dose. During the time that thesecond plunger356 is being moved in the distal direction, but prior to engagement with thefirst plunger352, any supposed air entrapped within thepassage350 will be directed through thehole354 and theopen hole362. In this manner, thesecond plunger356 can be moved unimpeded into engagement with thefirst plunger352 for delivery of the second single dose of the cream.

The remaining

stoppers

370 and372 can be removed successively in the manner of removal of thestopper368, as described above, to facilitate delivery of the remaining single dose applications of the cream. In addition, the

stoppers

368,370 and372 can each be attached to acommon strand374, to retain the removed stoppers together for single disposal.

Referring toFIGS. 31, 32,33 and34, a ninth embodiment of a focused dosimetry device, identified asdevice376, is typically used for multiple dose applications. Thedevice376 includes thedevice60, as shown inFIG. 1. Thedevice60 includes thecartridge62, thebarrel64, thepassage66, the finger-rest flange72, theplunger head100, thestem106, thethumb piece110 and thestem structure114. Thedevice376 also includes acarrier378, which is formed with a C-shaped cartridge-receivingnest380 and an integrally joinedshelf382. As shown inFIG. 34, the C-shapednest380, which is similar to the C-shapednest236 of the carrier234 (FIG. 14), is formed with

end portions

384 and386, which extend above the axis of the cartridge62 (FIG. 32). This facilitates reception of thecartridge62 within thenest380 by a snap fit to retain the cartridge with thecarrier378, in the manner described above with respect to thenest236 and thecartridge233.

Theshelf382 extends in a proximal direction from thenest380, and is fully below the axis of thecartridge62 as viewed inFIG. 32. Three

grooves

388,390 and392 are formed transaxially in aportion394 of theshelf382, and are formed with a width which will receive asection396 of the finger-rest flange72 as shown inFIG. 33. A U-shaped stem guide and stop398 is formed integrally with theshelf382 at the proximal end thereof.

In use, theapplicator80 is attached to the distal end of thecartridge62, and thestem106 is assembled within thepassage66 of the cartridge, with thestem structure114 being within thereceptor opening148 of theplunger head100. Theflange72 is aligned with thegroove388, which is the groove closest to the distal end of theshelf382, and thecartridge62 is snapped into the C-shapednest380, whereby the flange is moved into the groove. With thestem106 being in the fully extracted position, thethumb piece110 extends in the proximal direction from the proximal end of thestop398, with the extended distance of the thumb piece being representative of a prescribed distance that the stem is to be moved for the delivery of one dose of the cream through theapplicator80.

The patient-user inserts theapplicator80 into the vaginal or anal opening, and applies a force to thethumb piece110 in the distal direction to move thestem106 until thethumb rest112 engages thestop398. At this time, theplunger head100 has been moved to a position within thecartridge62 which is the “start” position for the plunger head for delivery of the next single dose of cream. The components of the device may be disassembled, cleaned, the distal end of thecartridge62 capped, stored or placed in a case, all in the manner described above.

When the time arrives for delivery of the next dose of the cream, the patient-user reassembles theapplicator80 and thestem106 with thecartridge62, and aligns theflange72 of the cartridge with themiddle groove390 of thecarrier378. Thecartridge62 is then snapped within thenest380 of thecarrier378, whereby thesection396 of the finger-rest flange72 is moved into themiddle groove390. At this time, thethumb piece110 is again extended in the proximal direction from the proximal end of thestop398 by virtue of having moved theflange72 to themiddle groove390. A force is applied to thethumb rest112 to move thestem106 for the prescribed distance into engagement with thestop398, which is representative of the delivery of a single dose of the cream through theapplicator80. Again, the components of thedevice376 can be disassembled as noted above.

When the time arrives for the application of the third single dose of the cream, the components of thedevice376 are reassembled. Thesection396 of theflange72 is aligned with thegroove392, which is the groove closest to the proximal end of theshelf382, and thecartridge62 is snapped into thenest380, whereby thesection396 seats in thegroove392. Again, thethumb piece110 extends in a proximal direction from the proximal end of thestop398 by the prescribed distance. A force is applied to thethumb rest112 and theplunger head100 is moved to dispense a single dose of the cream through theapplicator80.

Thedevice376, as described above, includes the three

grooves

388,390 and392, but could have more or less grooves without departing from the spirit and scope of the invention.

Referring toFIGS. 35, 36,38,39 and40, a tenth embodiment of a focused dosimetry device, identified asdevice400, is typically used for multiple dose applications. Thedevice376 includes thecartridge62 and theapplicator80. Aplunger head402 includes theplunger102 and areceptor section404, which is similar to thereceptor section104, but is formed with areceptor opening406 having an axially-alignedside wall408, rather than the tapered side wall at the taper angle “a” in thereceptor opening148. The cross section of thereceptor opening406 could be round, square or any suitable configuration to accomplish the function of the opening.

Aguide410 is assembled within the proximal end of thepassage66 of thecartridge62, and is formed with aflange412, which abuts the proximal end of the cartridge. As shown inFIGS. 35, 36 and39, afirst stem414 is formed with a prescribed length. Also, thefirst stem414 is formed at the distal end thereof with astem structure416 which is complementary to thereceptor opening406 for insertion of the stem structure within the receptor opening. Thestem414 is formed with a thumb-rest flange418 at the proximal end thereof. As shown inFIGS. 36 and 40, thedevice400 includes asecond stem420, which is formed in the configuration of thefirst stem414, except that the length of the second stem is greater than the prescribed length of the first stem.

In use of thedevice400, as shown inFIG. 38, two doses of the cream are placed in thepassage66 of thecartridge62 and theplunger head402 is firm against the distal end of theguide410 to insure proper location of the plunger head for a two-dose application. As shown inFIG. 39, thefirst stem414 is moved through theguide410 so that thestem structure416 is located within thereceptor opening406 when theplunger head402 is in a “start” position, as shown inFIG. 38. The “start” position of theplunger head402 is also shown in phantom inFIG. 39.

Theapplicator80 is placed in the vaginal opening or the anal opening, and a force is applied to the thumb-rest flange418 to move theplunger head402 in the distal direction. Eventually, theflange418 engages the proximal end of theguide410, whereby theplunger head402, as shown in solid inFIG. 39, has moved a distance sufficient for the dispensing of one dose of the cream through theapplicator80. The components of thedevice400 are disassembled, in the manner of disassembly of the components of the above-described devices, and can be cleaned, stored and placed in acase422, as shown inFIG. 36.

When the time arrives for administering the second of the two doses of cream, the components are reassembled, except that, for the second application, thesecond stem420 is used instead of thefirst stem414. With the longersecond stem420, as shown inFIG. 40, theplunger head402 is moved from the position illustrated in phantom to the position illustrated in solid, whereby the second dose of cream is dispensed through theapplicator80.

As shown inFIG. 37, a second embodiment of acap424 includes aninner sleeve426, which extends from a commondistal end portion428, and which is formed with a tapered axial opening430 and a pair of diametrically-opposed ears432. This portion of the structure of thecap424 is similar to the structure at the proximal end of theapplicator80 to fit over the small-diameter taperedsleeve74 of thecartridge62, and to threadedly engage the threaded inner wall of the large-diameter sleeve78. A larger cylindrical outer sleeve434 extends from thedistal end portion428, and is coaxially located about theinner sleeve426. When thecap424 is attached to the distal end of thecartridge62, theinner sleeve426 attaches in the same manner as theapplicator80 attaches, and the outer sleeve434 of the cap surrounds the large-diameter sleeve78 of the cartridge.

A second method, which continues from the first method described above, which includes thefirst stem414 and thesecond stem420, further includes the steps of (1) initially providing thecartridge62 having theaxial passage66, (2) inserting theplunger102 into the passage from the proximal end of the cartridge, (3) locating the plunger within the axial passage of the cartridge at the prescribed distance from the distal end of the cartridge, (4) and depositing the initial volume of the substance into the portion of the passage between the distal end of the plunger and the distal end of the cartridge.

A third method, which continues from the first method described above, which includes thefirst stem414 and thesecond stem420, further includes the steps of (1) initially providing thecartridge62 having theaxial passage66, (2) inserting theplunger102 into the passage from the proximal end of the cartridge, (3) locating the plunger at the distal end of the cartridge within the passage, (4) depositing the initial volume of the substance into the passage through the distal end of the cartridge; and (5) moving the plunger toward the proximal end of the cartridge by a force of the initial volume of the substance being deposited into the passage.

Referring toFIGS. 41, 42,43,44 and45, a first method of loading an initial volume of a substance into thecartridge62 includes the steps of (1) initially providing the cartridge having anaxial passage66, (2) inserting theplunger102 into the passage from a proximal end of the cartridge, (3) locating the plunger at a distal end of the cartridge within the passage, (4) depositing the initial volume of the substance into the passage through an opening at the distal end of the cartridge; and (5) moving the plunger toward the proximal end of the cartridge by a force of the initial volume of the substance being deposited into the passage.

A second method, which continues from the first method described above, of loading an initial volume of a substance into thecartridge62, further includes the step of (1) placing thecap122 over the opening at the distal end of the cartridge.

A third method, which continues from the first method described above, of loading an initial volume of a substance into thecartridge62, further includes the steps of (1) coupling theapplicator80 over the opening at the distal end of the cartridge, (2) inserting a distal end of the astem436 into the passage at the proximal end and into engagement with a proximal end of theplunger102, and (3) moving the stem, and thereby the plunger, toward the distal end of the cartridge to urge at least some of the substance from the passage, through and from the applicator.

A fourth method, which continues from the first method described above, of loading an initial volume of a substance into thecartridge62, further includes the step of providing a stop surface438 (FIGS. 46 and 47) within thepassage66 of the cartridge at a location at which theplunger102 is to be located when the initial volume of the substance has been deposited in the passage, where, upon depositing the substance into the passage, the force of the initial volume of the substance moves a proximal end of the plunger into engagement with the stop surface to preclude further depositing of the substance into the passage.

It is noted that, while the above-described various embodiments of the devices have included theapplicator80, theapplicator80aor theapplicator80bcould be used with any of the embodiments of the devices which include this type of applicator.

It is further noted that, as shown inFIGS. 43 and 46, a substance-supply dispenser440 is used to transfer the substance from the dispenser to thecartridge62.

Referring toFIG. 48, and in an alternative manner of describing the

applicators

80,80aand80b, which are shown inFIGS. 1 through 6, anapplicator580 includes a unitary body581, formed by six integrally-joined sections, identified as aproximal section770, aflange section772, apassage section774, adispensing section776, asolid section778, and adome section780. As noted above, the

applicators

80,80aand80b, as well as theapplicator580, are designed to facilitate the dispensing of a medicinal substance therethrough, where the medicinal substance has a cream-like consistency of the type which does not flow easily without a force being applied thereto.

The body581 of theapplicator580 is formed about anaxis782, which extends from aproximal end784 of the body to an exterioraxial surface786 of a closeddistal end788 of the body. Theproximal section770 of the body581 extends from theproximal end784 of the body toward the closeddistal end788 of the body, and to adistal end790 of the proximal section.

Theproximal section770 of the body581 is formed with anaxial entry passage582, which extends from theproximal end784 of the body toward the closeddistal end788 of the body, and to adistal end792 of the axial entry passage. Theaxial entry passage582 is formed with a prescribed diameter, at least at theproximal end784 of the body.

The body581 is also formed with an axialintermediate passage794 having aproximal end796, which is coincidental with thedistal end792 of theaxial entry passage582. The axialintermediate passage794 is formed with a uniform passage diameter, which is less than the prescribed diameter, and extends toward the closeddistal end788 of the body581, and to adistal end798 of the axial intermediate passage.

The body581 is formed about theaxis782 thereof with thepassage section774, which has a uniform exterior diameter. Thepassage section774 extends from aproximal end799 thereof toward the closeddistal end788 of the body, and to adistal end800 of the passage section, and fully surrounds at least a portion of the axialintermediate passage794 to thedistal end798 thereof.

The body581 is formed about theaxis782 thereof with thedispensing section776, which has the uniform exterior diameter. Thedispensing section776 extends from aproximal end802 thereof toward the closeddistal end788 of the body581, and to adistal end804 of the dispensing section, with theproximal end802 of the dispensing section formed integrally with thedistal end800 of thepassage section774.

Adistal delivery passage806 is formed axially through thedispensing section776 of the body581 from aproximal end808 of the distal delivery passage toward the closeddistal end788 of the body, and to a closeddistal end810 of the distal delivery passage, with the proximal end of the distal delivery passage being in communication with thedistal end798 of the axialintermediate passage794.

At least one dispensing passage is formed through thedispensing section776 of the body581 in unobstructed communication with thedistal delivery passage806 and an exterior of the body.

In theapplicator580, the at least one dispensing passage is in the form of an at least one axially-elongatedslot592, which is formed radially through thedispensing section776 of the body581 in unobstructed radial communication with thedistal delivery passage806 and an exterior of the body, and extends from theproximal end802 of the dispensing section toward thedistal end804 thereof, and to adistal end805 of the at least one axially-elongated slot. Thedistal delivery passage806 is formed with the uniform passage diameter, interrupted only by the presence of the at least one axially-elongatedslot592.

In addition to the at least one dispensing passage being in the form of the above-noted at least one axially-elongatedslot592, the at least one dispensing passage could be in a form other than the at least one axially-elongated slot, without departing from the spirit and scope of the invention. For example, the at least one dispensing passage could be in the form of a passage of the type illustrated inFIG. 2, and identified as one of theholes92. Further, the at least one dispensing passage could be in the form of a cylindrical passage with a uniform diameter of the type illustrated inFIG. 2, and identified as one theholes92. Still further, the at least one dispensing passage could be in the form of a plurality of dispensing passages of the type illustrated inFIG. 2, and identified as theholes92. In addition, the plurality of dispensing passages of the type illustrated inFIG. 2, and identified as theholes92, could be spaced axially within thedispensing section776, and could be located between theproximal end802 and thedistal end804 of the dispensing section. Additionally, the spacing between adjacent ones of theholes92, which form the plurality of dispensing passages, are equal.

The body581 is formed with thesolid section778, having the uniform exterior diameter, which extends from a closedproximal end814 of the solid section toward the closeddistal end788 of the body, and to a closeddistal end816 of the solid section. The closedproximal end814 of thesolid section778 is formed integrally with thedistal end804 of theslot section776.

The body581 is formed with thedome section780 in the form of a solid dome818, which extends from a closedproximal end820 of the dome section to a closeddistal end822 thereof, which is coincidental with the exterioraxial surface786 of the closeddistal end788 of the body581. The closedproximal end820 of thedome section780 is formed integrally with the closeddistal end816 of thesolid section778. Thesolid section788 and thedome section780 are exclusive of any opening.

It is noted that the axialintermediate passage794 of thepassage section774, and thedistal delivery passage806 of theslot section776, are axially aligned and combine to form theinner passage90, as illustrated, for example, inFIGS. 5 and 6. Further, as described above, and with reference toFIG. 48, the axially-aligned axialintermediate passage794 and thedistal delivery passage806 are formed with the uniform passage diameter.

As further shown inFIG. 48, a flange598 is located in theflange section772, between theproximal section770 and thepassage section774. The flange598 is integrally joined with adjacent portions of the body581, at opposite axial ends thereof, and fully radially surrounds a portion of the axialintermediate passage794. Thus, except for the presence of the at least one dispensing passage, successive portions of the body581, which are located in the three sections identified as theflange section772, thepassage section774 and thedispensing section776, surround the axial delivery passage90 (FIG. 5), which, as noted above, is formed by the axialintermediate passage794 and thedistal delivery passage806 illustrated inFIG. 48.

Referring toFIG. 48, the flange598 extends radially outward from anexterior surface594 of the body581 to anouter edge surface602 of the flange. The flange598 is formed with aproximal surface604 facing in a direction toward theproximal end784 of the body581 and adistal surface606 facing in a direction toward the closeddistal end788 of the body. Thedistal surface606 of the flange598 is formed by a straight portion606awhich extends from theouter edge surface602 of the flange, radially inward toward theaxis782 of the body581 and toward the closeddistal end788 of the body, to an inboard edge of the straight portion spaced radially outward from theexterior surface594 of the body. Thedistal surface606 of the flange598 is further formed with aconcave portion606bwhich extends from the inboard edge of the straight portion606atoward the closeddistal end788 of the body581, and to theexternal surface594 of the body.

Thus, with the structure of the body581 as described above, there is full communication from an exterior of the body581, at theproximal end784 thereof, through theaxial entry passage582, the axialintermediate passage794, thedistal delivery passage806, the at least one dispensing passage, and an exterior of the body adjacent the at least one dispensing passage.

In general, the above-identified embodiments are not to be construed as limiting the breadth of the present invention. Modifications, and other alternative constructions, will be apparent which are within the spirit and scope of the invention as defined in the appended claims.

Claims

1-68. (canceled)

69. An applicator for dispensing a medicinal substance therethrough, where the substance has a cream-like consistency of the type which does not flow easily without a force being applied thereto, which comprises:

a body formed about an axis which extends from a proximal end of the body to an exterior axial surface of a closed distal end of the body;

the body formed with a proximal section which extends from the proximal end of the body toward the closed distal end of the body, and to a distal end of the proximal section;

the proximal section of the body formed with an axial entry passage extending through the proximal section from the proximal end of the body toward the closed distal end of the body, and to a distal end of the axial entry passage;

the axial entry passage being formed with a prescribed diameter at the proximal end of the body;

the body being formed with an axial intermediate passage having a proximal end in communication with the distal end of the axial entry passage, and extending toward the closed distal end of the body, and to a distal end of the axial intermediate passage;

the axial intermediate passage being formed with a uniform passage diameter which is less than the prescribed diameter;

the body being formed about the axis thereof with a passage section, having a uniform exterior diameter, which extends from a proximal end thereof toward the closed distal end of the body, and to a distal end of the passage section;

the body formed with a flange section having a proximal end formed integrally with the distal end of the proximal section, and a distal end formed integrally with the proximal end of the passage section of the body;

a flange located in the flange section of the body and extending radially outward from the external surface of the body to an outer edge surface of the flange;

the passage section of the body fully surrounding at least a portion of the axial intermediate passage to the distal end of the axial intermediate passage;

the body being formed about the axis thereof with a dispensing section, having the uniform exterior diameter, which extends from a proximal end of the dispensing section toward the closed distal end of the body, and to a distal end of the dispensing section, with the proximal end thereof being formed integrally with the distal end of the passage section;

a distal delivery passage formed axially through the dispensing section of the body from a proximal end thereof toward the closed distal end of the body, and to a closed distal end of the distal delivery passage, with the proximal end of the distal delivery passage being in communication with the distal end of the axial intermediate passage;

at least one dispensing passage formed through the dispensing section of the body in communication with the distal delivery passage, at a first end of the at least one dispensing passage, and an exterior of the body, at a second end of the at least one dispensing passage;

the distal delivery passage being formed with the uniform passage diameter interrupted only by the presence of the at least one dispensing passage;

the body formed with a solid section, having the uniform exterior diameter, which extends from a closed proximal end of the solid section toward the closed distal end of the body, and to a closed distal end of the solid section, with the closed proximal end of the solid section being formed integrally with the distal end of the distal section;

the body formed with a dome section in the form of a solid dome, which extends from a closed proximal end of the dome section to a closed distal end of the dome section, which is coincidental with the exterior axial surface of the closed distal end of the body;

the closed proximal end of the dome section being formed integrally with the closed distal end of the solid section; and

the solid section and the dome section being exclusive of any opening.

70. The applicator as set forth inclaim 69, which further comprises:

the at least one dispensing passage formed in a configuration of a cylindrical passage from the first end thereof to the second end thereof.

71. The applicator as set forth inclaim 70, which further comprises:

the cylindrical passage of the at least one dispensing passage being formed with a uniform diameter from the first end of the at least one dispensing passage to the second end of the at least one dispensing passage.

72. The applicator as set forth inclaim 71, which further comprises:

the at least one dispensing passage extending radially from the axis of the body.

73. The applicator as set forth inclaim 69, which further comprises:

the at least one dispensing passage being in the form of a plurality of dispensing passages.

74. The applicator as set forth inclaim 73, which further comprises:

the plurality of dispensing passages being spaced axially within the dispensing section.

75. The applicator as set forth inclaim 73, which further comprises:

the plurality of passages being located between the proximal end of the dispensing section and the distal end of the dispensing section.

76. The applicator as set forth inclaim 73, which further comprises:

the spacing between adjacent dispensing passages of the plurality of dispensing passages being equal.

77. The applicator as set forth inclaim 69, which further comprises:

the flange having a proximal surface facing in a direction toward the proximal end of the body and a distal surface facing in a direction toward the closed distal end of the body;

the distal surface of the flange formed by a straight portion which extends from the outer edge of the flange, radially inward toward the axis of the body and toward the closed distal end of the body, to an inboard edge of the straight portion spaced radially outward from the external surface of the body; and

the distal surface of the flange formed with a concave portion which extends from the inboard edge of the straight portion toward the distal end, and to the external surface, of the body.