Focused dosimetry device and methods associated therewith

• US 20040015120A1
• Filed: 05/29/2003
• Published: 01/22/2004
• Est. Priority Date: 06/04/2002
• Status: Active Grant

• Current Assignee: Syringe, LLC
• Original Assignee: Innoject, Inc. (West Pharmaceutical Services Incorporated)
• Inventors: Salgado, Gervasio, Gillespie, Richard D., Berman, Irwin R.
• Granted Patent: US 7,125,394 B2
• Time in Patent Office: Days
• US Class Current: 604/11
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/31505 Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: A61M 5/31555 by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button

Abstract

A device 560, for administering multiple single doses of a medicated cream, includes a cartridge 562 having a barrel 564 for containing the cream, a plunger 608 for moving the cream from within the cartridge, and a stem 610 for moving the plunger within the cartridge. A carrier 612 is formed with a cartridge-receiving nest 712 for receiving the barrel 564. A plurality of spaced, transaxial grooves 726, 728, 730 and 732 are formed in the carrier 612 for receiving a flange 572 of the cartridge 562 during the dispensing of multiple, successive, single doses of the cream. The carrier 612 is formed with a pair of resilient ears 750 and 752 and a passage 738 for removably retaining the stem 610 with the carrier while allowing axial movement of the stem.

Claims

1. A focused dosimetry device, which comprises:

a cartridge formed with a barrel having a passage formed through the barrel along an axis thereof between a proximal end of the barrel and an axially spaced distal end of the barrel;

a plunger locatable and movable within the passage of the barrel;

the plunger formed with a proximal surface;

a stem having an integrally formed distal surface mounted for movement independently of the plunger through the proximal end of, and into the passage of, the barrel for interfacing engagement with the proximal surface of the plunger to facilitate movement of the plunger within the barrel toward the distal end of the barrel.

2. The focused dosimetry device as set forth in claim 1, which further comprises:

an applicator having a body attached to the distal end of the barrel;

the body formed with an axial delivery passage which is in communication with the barrel;

the axial delivery passage of the applicator extending from a proximal end of the body toward a closed distal end thereof; and

a plurality of slots formed spatially and radially through the body in communication with the axial delivery passage and an exterior of the body.

3. The focused dosimetry device as set forth in claim 1, which further comprises:

the proximal surface of the plunger having at least portions located at a prescribed angle with respect to the axis of the barrel; and

the distal surface of the stem having at least portions located at an angle with respect to the axis of the barrel, the angle being complementary to the prescribed angle.

4. The focused dosimetry device as set forth in claim 1, which further comprises:

the proximal surface of the plunger is perpendicular to the axis of the barrel; and

the distal surface of the stem is perpendicular to the axis of the barrel.

5. The focused dosimetry device as set forth in claim 1, which further comprises:

the proximal surface of the plunger is formed about the axis of the barrel in the shape of a conical recess; and

the distal surface of the stem is formed about the axis of the barrel in the shape of a cone which is complementary to the conical recess of the proximal surface of the plunger.

6. The focused dosimetry device as set forth in claim 1, which further comprises:

an insert located within the passage of the barrel between the proximal surface of the plunger and the distal surface of the stem;

the insert formed with a first face positioned for engagement with the proximal surface of the plunger; and

the insert formed with a second face positioned for engagement with the distal surface of the stem.

7. The focused dosimetry device as set forth in claim 1, which further comprises:

an insert located within the passage of the barrel between the proximal surface of the plunger and the distal surface of the stem;

a recess formed axially in the proximal surface of the plunger having a prescribed shape;

a projection extending in a distal direction from the insert and formed in a shape complementary to the prescribed shape for receipt of the projection within the recess; and

the insert formed with a face positioned for engagement with the distal surface of the stem.

8. The focused dosimetry device as set forth in claim 1, which further comprises:

a plunger head;

the plunger forming a compliant section of the plunger head with the compliant section facing the distal end of the barrel;

a receptor section of the plunger head facing the proximal end of the barrel, with the receptor section being comparatively more rigid than the compliant section;

a proximal end of the compliant section being coupled to a distal end of the receptor section;

a receptor opening formed in a proximal end of the receptor section of the plunger and having a prescribed configuration;

the stem having a stem structure at a distal end thereof which is generally complementary to the prescribed configuration of, and insertable into, the receptor opening; and

the prescribed configuration being structured to create a piloted engagement of the stem structure within the receptor opening and to preclude a taper-lock interference fit therebetween.

9. A carrier and stem assembly for a focused dosimetry device, which comprises:

a stem having a distal end and a proximal end spaced from the distal end thereof;

the stem formed with an intermediate section along an axis of the stem between the distal end and the proximal end thereof;

the intermediate section of the stem formed with a prescribed cross section;

a carrier;

means formed on the carrier for removably retaining the intermediate section of the stem with the carrier; and

means for allowing the intermediate section of the stem to be moved along the axis of the stem relative to the means for removably retaining the intermediate section.

10. A focused dosimetry device, which comprises:

a cartridge formed with a barrel having a passage through the barrel between a proximal end of the barrel and an axially spaced distal end of the barrel;

the barrel having an exterior shape of a prescribed configuration;

a plunger locatable and movable within the passage of the barrel;

a stem having a distal end positionable through the proximal end, and to a position within the passage, of the barrel to facilitate movement of the plunger within the barrel;

the stem formed with a proximal end spaced from the distal end thereof;

the stem formed with an intermediate section along an axis of the stem between the distal end and the proximal end thereof;

the intermediate section of the stem formed with a prescribed cross section;

a carrier formed with a barrel-receiving nest;

means for removably retaining the barrel within the barrel-receiving nest;

means for removably retaining the intermediate section of the stem with the carrier; and

means for allowing the intermediate section of the stem to be moved along the axis of the stem relative to the support member.

11. The focused dosimetry device as set forth in claim 10, which further comprises:

a flange formed on the barrel at the proximal end thereof;

a shelf formed on the carrier extending axially from a proximal end of the barrel-receiving nest toward a proximal end of the carrier; and

a plurality of spaced flange-receiving grooves formed transaxially in the shelf.

12. The focused dosimetry device as set forth in claim 11, which further comprises:

a stop surface formed on the carrier for limiting movement of the stem toward the distal end of the barrel.

13. The focused dosimetry device as set forth in claim 10, which further comprises:

the prescribed cross section of the intermediate section of the stem selected from the group consisting of a plus-sign cross section, a solid circular cross section, a hollow circular cross section, a solid square cross section, a hollow square cross section, a solid diamond cross section and a hollow diamond cross section.

14. The focused dosimetry device as set forth in claim 10, wherein the means for removably retaining the stem with the carrier comprises:

a support member located on the carrier;

a passage formed through the support member;

an opening formed in the support member in communication with the passage to facilitate positioning of at least a portion of the intermediate section of the stem within the passage; and

means for biasingly engaging the intermediate section of the stem to maintain the intermediate section of the stem within the passage.

15. The focused dosimetry device as set forth in claim 10, wherein the means for allowing movement of the stem with the carrier comprises:

a support member located on the carrier; and

a passage formed through the support member having a shape which conforms at least partially to the prescribed cross section of the intermediate section of the stem.

16. The focused dosimetry device as set forth in claim 14, wherein the means for biasingly engaging comprises:

the support member being formed with a pair of ears normally spaced apart by a distance which defines a normal width of the opening;

the pair of ears being sufficiently resilient to be spread farther apart by a distance greater than the normal width of the opening to facilitate movement of the intermediate section of the stem through the opening and into and out of the passage; and

the ears formed with portions which engage adjacent portions of the intermediate section of the stem when the intermediate section is located in the passage to maintain the intermediate section within the passage.

17. The focused dosimetry device as set forth in claim 10, which further comprises:

a thumb rest formed with a distal surface and a proximal portion;

the distal surface of the thumb rest being attached to the proximal end of the intermediate section; and

the proximal portion of the thumb rest being of a prescribed configuration.

18. The focused dosimetry device as set forth in claim 17, which further comprises:

the prescribed configuration of the proximal portion of the thumb rest selected from the group consisting of a flat configuration, a concave configuration;

a dished configuration; and

a ring configuration.

19. The focused dosimetry device as set forth in claim 10, which further comprises:

means formed on the carrier for facilitating the locating of the fingers of the user on the carrier during use of the device.

20. The focused dosimetry as set forth in claim 19, wherein the means for facilitating comprises:

a plurality of spaced grooves formed on a first side of the carrier opposite a second side of the carrier which includes the barrel-receiving nest.

21. An applicator for dispensing a substance therethrough, which comprises:

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

the axial entry passage being formed with a prescribed diameter;

the body being formed with an axial delivery passage having a proximal end in communication with the distal end of the axial entry passage;

the axial delivery passage of the applicator extending from the proximal end of the axial delivery passage body toward the distal end of the body and to a closed distal end of the axial delivery passage;

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

a least one elongated slot formed through the body in communication with the axial delivery passage and an exterior of the body; and

the at least one elongated slot formed with interfacing side walls which extend from a proximal end to a distal end of the at least one elongated slot.

22. The applicator as set forth in claim 21, which further comprises:

the interfacing side walls being uniformly spaced from each other between the proximal end to the distal end of the at least one elongated slot.

23. The applicator as set forth in claim 21, which further comprises:

the interfacing side walls being uniformly spaced from each other by a prescribed distance from the proximal end of the at least one elongated slot to an intermediate location between the proximal end and the distal end thereof; and

the interfacing side walls being uniformly separated by a distance greater than the prescribed distance from the intermediate location to the distal end of the at least one elongated slot.

24. The applicator as set forth in claim 21, which further comprises:

the interfacing side walls being separated by a first prescribed distance at the proximal end of the at least one elongated slot;

the interfacing side walls diverging from each other between the proximal end of the at least one elongated slot to an intermediate location between the proximal end and the distal end thereof at which the side walls are spaced apart by a second prescribed distance greater than the first prescribed distance; and

the interfacing side walls being uniformly separated by a distance equal to the second prescribed distance from the intermediate location to the distal end of the at least one elongated slot.

25. The applicator as set forth in claim 21, which further comprises:

the interfacing side walls being separated by a first prescribed distance at the proximal end of the at least one elongated slot; and

the interfacing side walls diverging from each other between the proximal end of the at least one elongated slot to the distal end thereof at which the side walls are spaced apart by a second prescribed distance greater than the first prescribed distance.

26. An applicator for dispensing a substance therethrough, which comprises:

a body formed with an exterior surface;

an axial delivery passage formed in the body with an interior wall having a diameter “

d”

;

the body formed with a thickness “

t”

between the interior wall of the axial delivery passage and the exterior surface of the body; and

the thickness “

t”

of the body being greater than the diameter “

d”

of the axial delivery passage.

27. An applicator for dispensing a substance therethrough, which comprises:

a body formed with an external diameter “

D”

;

an axial delivery passage formed in the body with a diameter “

d”

; and

the diameter “

d”

of the axial entry passage being equal to approximately twenty-five percent of the external diameter “

D”

of the body.

28. An applicator for dispensing a substance therethrough, which comprises:

a body formed with an axis and an external surface between a proximal end and a distal end thereof;

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

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 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 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.

29. A cartridge and applicator assembly for a focused dosimetry device, which comprises:

a cartridge formed with a barrel having a distal end;

the barrel formed with an axial passage having a prescribed diameter;

an applicator formed with a body having a proximal end;

the applicator formed with an axial delivery passage having a uniform diameter which is less than the prescribed diameter between a proximal end and a distal end thereof; and

means for attaching the proximal end of the applicator to the distal end of the barrel such that the axial passage of the barrel is in communication with the axial delivery passage of the applicator.

30. A method of dispensing successively two equal amounts of a substance from a distal end of a barrel containing the substance, which comprises the steps of:

placing a distal end of a stem through a proximal end of the barrel and into engagement with a plunger within the barrel;

placing the barrel with the stem at a first prescribed location;

moving the stem toward the distal end of, and relative to, the barrel thereby moving the plunger to dispense the substance from the distal end of the barrel;

moving a surface of the stem into engagement with a stop surface after the stem has travelled through a prescribed stem-travel distance, relative to the barrel, whereby a given amount of the substance has been dispensed from the distal end of the barrel;

moving the barrel with the stem to a second prescribed location in a proximal direction away from the first prescribed location whereby the surface of the stem is spaced from the the stop surface by a distance equal to the prescribed stem-travel distance;

moving the stem toward the distal end of, and relative to, the barrel to dispense the substance from the distal end of the barrel; and

moving the surface of the stem into engagement with the stop surface after the stem has travelled through the prescribed stem-travel distance whereby an amount of the substance equal to the given amount has been dispensed from the distal end of the barrel.

31. The method as set forth in claim 30, which further comprises the steps of:

removing the stem from the barrel after the given amount of the substance has been dispensed from the distal end of the barrel during a period when the barrel is at the first prescribed location; and

reinserting the proximal end of the stem through the proximal end of the barrel and into engagement with the plunger after the barrel has been moved to the second prescribed location.

32. The method as set forth in claim 30, which further comprises the steps of:

providing a carrier having the stop surface at a proximal end thereof, a distal end, a first groove formed transverse to an axis of the carrier intermediate the proximal end and the distal end thereof, a second groove formed transverse to the axis of the carrier intermediate the proximal end and the distal end of the carrier and spaced from the first groove toward the proximal end of the carrier by a distance equal to the prescribed stem-travel distance, the first groove being closer to the distal end of the carrier than the second groove;

placing a flange of the barrel in the first groove on the carrier when the barrel is placed at the first prescribed location;

removing the flange of the barrel from the first groove on the carrier following the dispensing of the given amount of the cream; and

placing the flange of the barrel in the second groove on the carrier when the barrel is placed at the second prescribed location.

33. The method as set forth in claim 32, which further comprises, prior to placing the distal end of the stem through the proximal end of the barrel and into engagement with the plunger within the barrel, the step of;

mounting an intermediate section of the stem on the carrier for movement of the stem relative to the carrier.

34. The method as set forth in claim 32, which further comprises the step of:

mounting the barrel on the carrier in a stationary position relative to the carrier when the barrel is placed in the first prescribed location; and

mounting the barrel on the carrier in a stationary position relative to the carrier when the barrel is placed in the second prescribed location.

35. The method as set forth in claim 32, wherein the plunger has assumed a prescribed location within the barrel upon completion of the dispensing of the given amount, which further comprises the step of:

maintaining the plunger in the prescribed location at least during a period between the steps of removing of the flange from the first groove and the placing of the flange in the second groove.