Disposable fluid injection module

• US 6,045,534 A
• Filed: 10/27/1997
• Issued: 04/04/2000
• Est. Priority Date: 10/27/1997
• Status: Expired due to Term

• Current Assignee: SARCOS LC (Sarcos Technology & Robotics Corp.)
• Original Assignee: Sarcos Incorporated (Rtx Corporation)
• Inventors: Best, Aaron M., Sinnott, M. Mary, Jacobsen, Stephen C., Petelenz, Tomasz J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Gring, Kent
• Application Number:
  US08/957,520
• Time in Patent Office: 890 Days
• Field of Search: 604/140, 604/49, 604/51, 604/68, 604/69, 604/131, 604/141, 604/143, 604/144, 604/145, 604/146, 604/147, 604/156, 604/30
• US Class Current: 604/156
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/3022 Worn on the body, e.g. as patches pressure infusion of the skin patch type A61M5/14248
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2429 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/283 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/31568 : Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/31578 : based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
• CPC Class Codes: A61M 5/31591 : Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/3232 : Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61N 1/30 : Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

An automated injection module is comprised of a housing, a piston drug capsule disposed within the housing, a piston core including a puncture seal membrane defining a reservoir for holding a drug between the puncture seal membrane and the piston drug capsule, an injection device having at least one sharp end for puncturing the puncture seal upon activation of the device, an end cap on a distal end of the housing, and a pressure source on a proximal end of the housing. The pressure source is preferably a propellant that ignites and forces the piston toward the distal end. Substantially simultaneously, the injection device pierces the puncture seal membrane, the piston core is forced into the piston drug capsule, and the drug is evacuated from the reservoir through the injection device and into a patient.

Claims

1. An apparatus for delivering a drug, comprising:

a) a housing disposed within said first chamber, said piston defining a second proximal end and defining a first chamber therein;

b) a piston disposed within said first chamber, said piston defining a second chamber therein;

c) a piston core movably disposed within said second chamber of said piston and defining a reservoir between said piston and said piston core;

d) a pressure source proximate said proximal end and in communication with said first chamber;

e) an injection device coupled to the piston core and in communication with said reservoir for delivery of a dose of a drug contained therein;

f) an adjustment device coupled to the housing for adjusting the dose; and

g) the piston core includes an externally threaded spindle attached on a distal end to an adjustment knob and threadedly engaged with an internally threaded ring, said ring engaged with said housing and providing a stop for said piston upon activation of said pressure source.

2. The apparatus of claim 1, further including a puncture seal coupled to said piston core and interposed between said reservoir and said injection device.

3. The apparatus of claim 2, wherein said puncture seal forms a seal between said piston core and said piston.

4. The apparatus of claim 2, wherein said injection device comprises a hollow needle attached to said piston core and extending toward said distal end.

5. The apparatus of claim 4, wherein said hollow needle is sharp on a first end and a second end, said first end positioned proximate said puncture seal.

6. The apparatus of claim 2, wherein said injection device comprises an elongate nozzle having a sharp end positioned proximate said puncture seal and a blunt end for injecting the drug at an injection site.

7. The apparatus of claim 2, wherein said piston core defines an inwardly tapered frustoconical surface forming a space between said frustoconical surface and said puncture seal and wherein at least a portion of said injection device resides within said space.

8. The apparatus of claim 2, wherein said puncture seal includes a frustoconical portion defining a space between said frustoconical portion and said piston core, and wherein at least a portion of said injection device resides within said space.

9. The apparatus of claim 2, wherein said piston core defines a recess therein sized and shaped to receive said puncture seal therein, said puncture seal positioned proximate said recess and defining a space thereinbetween, and wherein at least a portion of said injection device resides within said space.

10. The apparatus of claim 1, further including a vent in communication with said first chamber.

11. A drug delivery apparatus, comprising:

housing means for providing a first chamber therein;

piston means disposed within said housing means for sliding within said first chamber, said piston means defining a second chamber therein;

plunger means movably disposed within said second chamber of said piston means for forming a reservoir within the piston means;

pressure means for forcing said piston means through said first chamber and said plunger means into said reservoir; and

injection means coupled to said plunger means and in communication with said reservoir for delivery of a dose of drug contained within said reservoir.

12. The apparatus of claim 11, further including a sealing means coupled to said plunger means and interposed between said reservoir and said injection means.

13. The apparatus of claim 12, wherein said sealing means forms a seal between said plunger means and said piston means.

14. The apparatus of claim 12, wherein said injection means comprises a hollow needle attached to said plunger means.

15. The apparatus of claim 14, wherein said hollow needle is sharp on a first end and a second end, said first end positioned proximate said sealing means.

16. The apparatus of claim 11, wherein said injection means comprises a nozzle.

17. The apparatus of claim 11, further including venting means for venting said first chamber.

18. The apparatus of claim 17, wherein said venting means further includes disengageable sealing means for allowing ventilation of said first chamber.

19. The apparatus of claim 11, further including adjustment means for adjusting the dose of the drug contained within said reservoir.

20. An apparatus for delivering a drug, comprising:

a) a housing having a first and second chamber therein;

b) a piston, positioned within the housing and between the first and second chambers, having a reservoir therein for containing the drug to be delivered;

c) an injection device, positioned to extend into the reservoir, coupled to the piston and extending into the second chamber, for injecting the drug out of the reservoir; and

d) located in the first chamber, a propellant and an electrical circuit that has a first fusible link for igniting the propellant and thereby delivering the drug.

21. The apparatus of claim 20, wherein the electrical circuit is mounted on a printed circuit board that has a vent containing a meltable material and positioned next to a second fusible link.

22. The apparatus of claim 20, wherein the piston further comprises an externally threaded spindle attached on a distal end to an adjustment knob and threadedly engaged with an internally threaded ring that is engaged with the housing and providing a stop for the piston upon activation of the propellant.

23. The apparatus of claim 20, further comprising a biasing device, located in the second chamber, for retracting the injection device after the drug has been delivered.

24. The apparatus of claim 23, wherein the biasing device is a spring positioned around the injection device.

25. The apparatus of claim 20, further comprising an adjustment device coupled to the housing for adjusting a dose of the drug to be delivered.

26. An apparatus for delivering a drug, comprising:

a) a housing having a first and second chamber therein;

b) a piston, positioned within the housing and between the first and second chambers, having a reservoir therein for containing the drug to be delivered;

c) an injection device, positioned to be extended into the reservoir and out of the housing, for delivering the drug out of the reservoir; and

d) a biasing device, located proximate the piston, for retracting the injection device into the housing after the drug has been delivered.

27. The apparatus of claim 26, further comprising:

located in the first chamber, a propellant and an electrical circuit including a first fusible link disposed adjacent the propellant for igniting the propellant, which causes the injection device to extend outside the housing to deliver the drug.

28. The apparatus of claim 27, wherein the electrical circuit is mounted on a printed circuit board that has a vent containing a meltable material and positioned next to a second fusible link.

29. The apparatus of claim 26, wherein the piston further comprises an externally threaded spindle attached on a distal end to an adjustment knob and threadedly engaged with an internally threaded ring that is engaged with the housing and providing a stop for the piston upon activation of the propellant.

30. The apparatus of claim 26, wherein the biasing device is a spring positioned around the injection device.

31. An apparatus for delivering a drug, comprising:

a) a housing having a distal end through which the drug is delivered and a proximal end and defining a first chamber therein;

b) a piston disposed within said first chamber, said piston defining a second chamber therein;

c) a piston core movably disposed within said second chamber of said piston and defining a reservoir between said piston and said piston core;

d) a pressure source proximate said proximal end and in communication with said first chamber;

e) an injection device coupled to the piston core and in communication with said reservoir for delivery of a dose of a drug contained therein;

f) a biasing device disposed in the chamber and contacting the piston core for biasing said injection device toward said proximal end;

g) an end cap attached to said distal end of said housing; and

h) the biasing device is a spring interposed between said end cap and said piston core.

32. An apparatus for delivering a drug, comprising:

a) a housing having a distal end through which the drug is delivered and a proximal end and defining a first chamber therein;

b) a piston disposed within said first chamber, said piston defining a second chamber therein;

c) a piston core movably disposed within said second chamber of said piston and defining a reservoir between said piston and said piston core;

d) a pressure source proximate said proximal end and in communication with said first chamber;

e) an injection device coupled to the piston core and in communication with said reservoir for delivery of a dose of a drug contained therein;

f) a biasing device disposed in the chamber and contacting the piston core for biasing said injection device toward said proximal end; and

g) an end cap attached to said distal end of said housing, the end cap includes a curved wall defining a channel therein for encouraging said injection device to bend at an angle relative to a longitudinal axis of said injection device.

33. The apparatus of claim 32, wherein said injection device comprises a hollow needle attached to said piston core and comprised of a nickle/titanium alloy.

34. The apparatus of claim 33, wherein said pressure source is an igniter circuit including at least one resistor and propellant proximate said at least one resistor and said trigger comprises at least one power source for heating said at least one resistor and a switch.

35. The apparatus of claim 34, wherein said at least one resistor is an approximately 1 to 10 ohm resistor and said at least one power source includes at least one battery having a voltage approximately 1 to 6 volts.

36. A drug delivery apparatus, comprising;

a) housing means for providing a first chamber therein;

b) piston means disposed within said housing means for sliding within said first chamber, said piston means defining a second chamber therein;

c) plunger means movably disposed within said second chamber of said piston means for forming a reservoir within the piston means;

d) pressure means for forcing said piston means through said first chamber and said plunger means into said reservoir;

e) injection means coupled to said plunger means and in communication with said reservoir for delivery of a dose of drug contained within said reservoir;

f) the pressure means includes gas generating means for creating a gas and initiating mans for introducing said gas into said first chamber; and

g) the initiating means is an electrical circuit comprising an electrical source and a fusible link, said electrical source providing electrical current to heat said fusible link and ignite said propellant.

37. A drug delivery apparatus, comprising:

a) housing means for providing a first chamber therein;

b) piston means disposed within said housing means for sliding within said first chamber, said piston means defining a second chamber therein;

c) plunger means movably disposed within said second chamber of said piston means for forming a reservoir within the piston means;

d) pressure means for forcing said piston means through said first chamber and said plunger means into said reservoir;

e) injection means coupled to said plunger means and in communication with said reservoir for delivery of a dose of drug contained within said reservoir; and

f) the adjustment means includes adjustable stop means associated with said plunger means for stopping movement of said piston means upon activation of said pressure means.