Apparatus for dispensing medicinal fluids and method of making same
A dispensing device and the method of making same for dispensing medicaments to a patient that includes a housing, a first assembly connected to the first end of the housing that includes a body portion, and a penetrating sub-assembly. The first assembly also includes a rate control chip of novel construction that is connected to the penetrating sub-assembly and functions to control the rate of flow of medicinal fluid to the patient. Disposed within the housing is a second assembly that includes a shuttle, a collapsible container carried by the shuttle and a plurality of variable force springs that function to thrust the collapsible container into penetrating engagement with the penetrating member of the penetrating assembly and then to collapse the collapsible container to deliver the medicinal fluid to the patient. Connected to the second end of the housing is a novel third assembly that includes an operating member that functions to controllably move the shuttle forwardly of the housing.
1. An apparatus for dispensing medicinal fluids to a patient comprising:
(a) A generally cylindrically shaped housing having first and second ends and a longitudinally extending center line;
(b) a first assembly connected to said first end of said housing, said first assembly comprising:
(i) a front cover;
(ii)a fluidics hub disposed within said front cover;
(iii) a penetrating sub-assembly connected to said fluidics hub, said penetrating sub assembly comprising a mounting plate and a penetrating member connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway; and
(iv) a rate control assembly connected to said penetrating sub-assembly, said rate control assembly including a rate control member having a micro-channel formed therein in communication with said fluid passageway of said penetrating member;
(c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
(i) a threaded shuttle; and
(ii) a collapsible container carried by said threaded shuttle, said collapsible container including a neck portion having a closure wall pierceable by said penetrating member and having a longitudinal center line aligned with said longitudinal center line of said housing;
(d) a first operating assembly operably associated with said second assembly for controlled movement of said second assembly within said housing from said first position to said second advanced position;
(e) a second operating assembly operably associated with said second assembly for controllably advancing said second assembly within said housing from said second advanced position to a further advanced position; and
(f) a disabling assembly carried by said generally cylindrically shaped housing for preventing operation of said first operating assembly of said second assembly.
2. The apparatus as defined in claim 1 in which said second operating assembly comprises a variable force spring.
3. The apparatus as defined in claim 1 further including an alignment sleeve disposed within said housing and operably associated with collapsible container of said second assembly for aligning said collapsible container with said longitudinally extending center line of said housing.
4. The apparatus as defined in claim 1 in which said collapsible container includes a base portion having an inwardly extending protuberance and in which said threaded shuttle includes an alignment protuberance receivable within said inwardly extending protuberance of said base portion of said collapsible container.
5. The apparatus as defined in claim 1 in which said second assembly further includes an alignment sleeve having an axial bore, said neck portion of said collapsible container being telescopically receivable within said axial bore of said alignment sleeve.
6. An apparatus for dispensing medicinal fluids to a patient comprising:
(a) a generally cylindrically shaped housing having first and second ends and a longitudinally extending center line;
(b) a first assembly connected to said first end of said housing, said first assembly comprising:
(i) a front cover;
(ii) a fluidics hub disposed within said front cover, said fluidics hub having a generally cylindrical bore;
(iii) a penetrating sub-assembly connected to said fluidics hub, said penetrating sub assembly comprising a mounting plate and a penetrating member connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway; and
(iv) a rate control assembly connected to said penetrating sub-assembly, said rate control assembly including a rate control member having a micro-channel formed therein in communication with said fluid passageway of said penetrating member;
(c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
(i) a threaded shuttle;
(ii) a collapsible container carried by said externally threaded shuttle, said collapsible container having a longitudinal center line aligned with said longitudinal center line of said housing and including a neck portion having a closure wall and a base portion having an inwardly extending ullage; and
(iii) an alignment sleeve having an axial bore, said neck portion of said collapsible container being telescopically receivable within said axial bore of said alignment sleeve;
(d) an internally threaded end cap threadably connected to said shuttle for rotational movement relative thereto between a first position and a second position to move said shuttle of said second assembly within said housing along said longitudinally extending center line from said first position to said second advanced position;
(e) stored energy means operably associated with said shuttle for moving said shuttle along said longitudinally extending center line from said second advanced position to a further advanced position; and
(f) a disabling assembly carried by said generally cylindrically shaped housing for preventing rotation of said internally threaded end cap, said disabling assembly comprising a thin-film encapsulating said generally cylindrically shaped housing and a portion of said internally threaded end cap.
7. The apparatus as defined in claim 6 in which said stored energy means comprises a plurality of circumferentially spaced, variable force springs carried by said shuttle.
8. The apparatus as defined in claim 6 in which said thin-film of said disabling assembly comprises a heat shrinkable polyolefin film.
9. The apparatus as defined in claim 6 in which said generally cylindrically shaped housing is substantially transparent and in which said apparatus further includes a cover circumscribing said housing and having a window superimposed over said shuttle.
10. The apparatus as defined in claim 6 further including an administration line connected to said rate control assembly.
11. The apparatus as defined in claim 6 in which said threaded shuttle includes a plurality of circumferentially spaced alignment protuberances receivable within said ullage of said base portion of said collapsible container.
12. An apparatus for dispensing medicinal fluids to a patient comprising:
(a) a generally cylindrically shaped housing having first and second ends and a longitudinally extending center line;
(b) a first assembly connected to said first end of said housing, said first assembly comprising:
(i) a front cover;
(ii) a fluidics hub disposed within said front cover; said fluidics hub includes a generally cylindrical bore
(iii) a penetrating sub-assembly connected to said fluidics hub, said penetrating sub assembly comprising a mounting plate and a penetrating member connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway; and
(iv) a rate control assembly connected to said penetrating sub-assembly, said rate control assembly including a rate control member having a micro-channel formed therein in communication with said fluid passageway of said penetrating member;
(c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
(i) a threaded shuttle;
(ii) a collapsible container carried by said threaded shuttle, said collapsible container including a neck portion having a closure wall pierceable by said penetrating member and having a longitudinal center line aligned with said longitudinal center line of said housing; and
(iii) an alignment sleeve telescopically receivable within said generally cylindrical bore of said fluidics hub;
(d) a first operating assembly operably associated with said second assembly for controlled movement of said second assembly within said housing from said first position to said second advanced position;
(e) a second operating assembly operably associated with said second assembly for controllably advancing said second assembly within said housing from said second advanced position to a further advanced position; and
(f) a disabling assembly carried by said generally cylindrically shaped housing for preventing operation of said first operating assembly of said second assembly.
13. An apparatus for dispensing medicinal fluids to a patient comprising:
(a) a generally cylindrically shaped housing having first and second ends and a longitudinally extending center line;
(b) a first assembly connected to said first end of said housing, said first assembly comprising:
(i) a front cover;
(ii) a fluidics hub disposed within said front cover;
(iii) a penetrating sub-assembly connected to said fluidics hub, said penetrating sub assembly comprising a mounting plate and a penetrating member connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway; and
(iv) a rate control assembly connected to said penetrating sub-assembly, said rate control assembly including a rate control member having a micro-channel formed therein in communication with said fluid passageway of said penetrating member;
(c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
(i) a threaded shuttle; and
(ii) a collapsible container carried by said threaded shuttle, said collapsible container including a neck portion having a closure wall pierceable by said penetrating member and having a longitudinal center line aligned with said longitudinal center line of said housing;
(d) a first operating assembly operably associated with said second assembly for controlled movement of said second assembly within said housing from said first position to said second advanced position, said first operating assembly including a locking mechanism;
(e) a second operating assembly operably associated with said second assembly for controllably advancing said second assembly within said housing from said second advanced position to a further advanced position, said locking mechanism of said first operating assembly being constructed and arranged to prevent operation of said second operating assembly; and
(f) a disabling assembly carried by said generally cylindrically shaped housing for preventing operation of said first operating assembly of said second assembly.
14. The apparatus as defined in claim 13 in which said first operating assembly comprises an end cap rotatably connected to said second end of said housing and in which said locking mechanism comprises threads provided on said end cap.
15. The apparatus as defined in claim 14 in which said disabling assembly comprises a thin-film encapsulating said generally cylindrically shaped body portion and a portion of said end cap.
16. An apparatus for dispensing medicinal fluids to a patient comprising:
(a) a generally cylindrically shaped housing having first and second ends and a longitudinally extending center line, said second end of said generally cylindrically shaped housing being provided with a multiplicity of circumferentially spaced, saw tooth like protrusions;
(b) a first assembly connected to said first end of said housing, said first assembly comprising:
(i) a front cover;
(ii) a fluidics hub disposed within said front cover, said fluidics hub having a generally cylindrical bore;
(iii) a penetrating sub-assembly connected to said fluidics hub, said penetrating sub-assembly comprising a mounting plate and a penetrating member connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway; and
(iv) a rate control assembly connected to said penetrating sub-assembly, said rate control assembly including a rate control member having a micro-channel formed therein in communication with said fluid passageway of said penetrating member;
(c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
(i) a threaded shuttle;
(ii) a collapsible container carried by said externally threaded shuttle, said collapsible container having a longitudinal center line aligned with said longitudinal center line of said housing and including a neck portion having a closure wall and a base portion having an inwardly extending ullage; and
(iii) an alignment sleeve having an axial bore, said neck portion of said collapsible container being telescopically receivable within said axial bore of said alignment sleeve;
(d) an internally threaded end cap threadably connected to said shuttle for rotational movement relative thereto between a first position and a second position to move said shuttle of said second assembly within said housing along said longitudinally extending center line from said first position to said second advanced position, said internally threaded end cap including an outwardly protruding locking finger engageable with said saw tooth like protrusions;
(e) stored energy means operably associated with said shuttle for moving said shuttle along said longitudinally extending center line from said second advanced position to a further advanced position; and
(f) a disabling assembly carried by said generally cylindrically shaped housing for preventing rotation of said internally threaded end cap, said disabling assembly comprising a thin-film encapsulating said generally cylindrically shaped housing and a portion of said internally threaded end cap.
17. An apparatus for dispensing medicinal fluids to a patient comprising:
(a) a generally cylindrically shaped housing having first and second ends and a longitudinally extending center line;
(b) a first assembly connected to said first end of said housing, said first assembly comprising:
(i) a front cover;
(ii) a fluidics hub disposed within said front cover, said fluidics hub having a generally cylindrical bore;
(iii) a penetrating sub-assembly connected to said fluidics hub, said penetrating sub-assembly comprising a mounting plate and a penetrating member connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway; and
(iv) a rate control assembly connected to said penetrating sub-assembly, said rate control assembly including a rate control member having a micro-channel formed therein in communication with said fluid passageway of said penetrating member;
(c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
(i) a threaded shuttle;
(ii) a collapsible container carried by said externally threaded shuttle, said collapsible container having a longitudinal center line aligned with said longitudinal center line of said housing and including a neck portion having a closure wall and a base portion having an inwardly extending ullage; and
(iii) an alignment sleeve telescopically receivable within said generally cylindrical bore of said fluidics hub, said alignment sleeve having an axial bore, said neck portion of said collapsible container being telescopically receivable within said axial bore of said alignment sleeve;
(d) an internally threaded end cap threadably connected to said shuttle for rotational movement relative thereto between a first position and a second position to move said shuttle of said second assembly within said housing along said longitudinally extending center line from said first position to said second advanced position;
(e) stored energy means operably associated with said shuttle for moving said shuttle along said longitudinally extending center line from said second advanced position to a further advanced position; and
(f) a disabling assembly carried by said generally cylindrically shaped housing for preventing rotation of said internally threaded end cap, said disabling assembly comprising a thin-film encapsulating said generally cylindrically shaped housing and a portion of said internally threaded end cap.