Multipathway electronically-controlled drug delivery system

• US 5,860,957 A
• Filed: 02/07/1997
• Issued: 01/19/1999
• Est. Priority Date: 02/07/1997
• Status: Expired due to Term

• Current Assignee: SARCOS LC (Sarcos Technology & Robotics Corp.)
• Original Assignee: Sarcos Incorporated (Rtx Corporation)
• Inventors: Jacobsen, Stephen C., Petelenz, Tomasz J., Peterson, Stephen C., Wyatt, Roland
• Primary Examiner(s): Stright, Jr., Ronald
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/797,295
• Time in Patent Office: 711 Days
• Field of Search: 604/30, 604/31, 604/65-71, 604/118, 604/131, 604/140, 604/151, 604/153, 604/156, 604/246
• US Class Current: 604/156
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• 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 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/282 by compression of deformable ampoule or carpule wall
• 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 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• 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

A low-profile multipathway automatic drug delivery system utilizing a battery powered control pad coupled to a disposable drug storage and delivery system and strapped to a patient'"'"'s limb or torso. A preprogrammed or on-demand drug administration sequence is input to the control pad. When a drug is to be administered, the control pad ignites a high energy density propellant charge in the drug delivery system. Expanding propellant gas exerts pressure on a drug in a second chamber and forces it from the storage reservoir. Depending upon the type of drug delivery system required for the drug being administered, the propellant will either: (i) force a hypodermic needle into a patient'"'"'s muscle tissue, propel the drug in the storage container into the needle embedded in the patient, and withdraw the needle; (ii) force the drug from the storage container through a jet nozzle where the drug is injected into subcutaneous tissue; (iii) force the drug from the storage container into a patch for passive transdermal delivery; (iv) force the drug into a patch for iontophoretic transdermal diffusion; or (v) force together two drugs stored separately that are unstable when mixed, and then administer them through one of the methods described in steps (i) to (iv).

Claims

1. A multipathway automatic and on-demand drug delivery system for multiple administrations at selectable dispensing times of at least one type of drug, said system comprising:

a plurality of drug storage and delivery means wherein each has at least one drug storage reservoir and an actuable drug delivery system which receives a signal causing the drug delivery system to eject the at least one type of drug from the at least one drug storage reservoir, said plurality of drug storage and delivery means comprising;

a plurality of generally hollow dual-chambered delivery pods having an enclosed top face and bottom face, and where the chambers are generally arranged as an upper chamber and a lower chamber;

the upper chamber which functions as a propellant chamber having a ceiling a combustible propellant charge in the propellant chamber which is proximate to the ceiling;

an ignition means for igniting the combustible propellant charge;

a piston located between the propellant chamber and the lower chamber, wherein said piston has generally flat top and bottom faces;

the lower chamber functioning as a drug reservoir chamber situated beneath the piston, having the piston as a ceiling, a puncturable membrane associated with said drug reservoir chamber; and

an outlet port beneath the puncturable floor membrane and extending through an aperture in the bottom face of the drug reservoir chamber to enable ejection of the drug therefrom;

a drug storage and delivery module which holds the plurality of drug storage and delivery means in position until ejection of the at least one type of drug therefrom;

a securing means for coupling the drug storage and delivery module to a patient; and

a control means which is coupled to the drug storage and delivery module and which transmits the signal causing the drug delivery system to eject the at least one type of drug at the selectable dispensing times.

2. The drug delivery system as defined in claim 1 wherein the control means which communicates bidirectionally with the drug storage and delivery module is coupled therebetween via a hardwired communication link.

3. The drug delivery system as defined in claim 2 wherein the hard-wired communication link is selected from the group of hard-wired communication links consisting of coaxial cable, twisted pair, straight wire, and optical fiber.

4. The drug delivery system as defined in claim 1 wherein the control means which communicates bidirectionally with the drug storage and delivery module is coupled therebetween via a wireless communication link.

5. The drug delivery system as defined in claim 4 wherein the system further comprises a sensor means coupled to the control means for monitoring physiological parameters of the patient and providing them to the control means, and wherein drug therapy is modifiable based upon the physiological parameters from the sensor means.

6. The drug delivery system as defined in claim 4 wherein the control means further comprises:

a data entry means for programming instructions into control means memory to regulate drug administration;

a display means for showing programmed instructions, recorded information and system status;

a processing means for executing programmed instructions;

a memory means for storing programmed instructions and for recording drug administration data;

a first interface means for transferring information stored in the memory means to and from an external information host; and

a second interface means for communicating with the drug storage and delivery module.

7. The drug delivery system as defined in claim 6 wherein the data entry means is a keypad for interfacing with the control means, and which includes an on-demand button for immediate delivery of a desired drug from the drug storage and delivery means.

8. The drug delivery system as defined in claim 6 wherein the control means is battery powered for mobile operation of the system.

9. The drug delivery system as defined in claim 6 wherein the display means further comprises a liquid crystal display (LCD) screen.

10. The drug delivery system as defined in claim 6 wherein the processing means for executing programmed instructions further comprises a programmable processor.

11. The drug delivery system as defined in claim 6 wherein the memory means for storing programmed instructions and for recording drug administration data further comprises non-volatile RAM that will retain memory contents when power to RAM is removed.

12. The drug delivery system as defined in claim 11 wherein the memory means for storing programmed instructions and for recording drug administration data is comprised of flash memory.

13. The drug delivery system as defined in claim 6 wherein the interface means for transferring information stored in the memory means to an external host is comprised of an RS-232 interface.

14. The drug delivery system as defined in claim 1 wherein the drug storage and delivery means are selected from the group of delivery systems consisting of iontophoretic delivery means, transdermal diffusion delivery means, fluid jet delivery means, hypodermic needle delivery means, pre-delivery drug mixing means, and needle delivery means.

15. The drug delivery system as defined in claim 14 wherein the iontophoretic, transdermal diffusion, and fluid jet delivery means further comprise:

at least two electric leads extending from outside the top face of the pod and through the top face and extending partially into the propellant chamber through the ceiling of said propellant chamber;

said ignition means for igniting the combustible propellant charge coupled to the at least two electric leads and covered by the combustible propellant charge; and

an outlet port beneath the puncturable floor membrane and extending through an aperture in the bottom face of the drug reservoir chamber to enable ejection of the drug therefrom.

16. The drug delivery system as defined in claim 15 wherein the drug reservoir chamber is provided in a plurality of different sizes to allow variation in drug dosages which may be delivered by the system.

17. The drug delivery system as defined in claim 1 wherein the drug storage and delivery means is disposable.

18. The drug delivery system as defined in claim 15 wherein the plurality of generally dual-chambered delivery pods further comprise generally cylindrical shapes, wherein the walls of the upper and lower chambers are generally circular, and wherein the piston is a generally circular disk which is slightly smaller in diameter than the drug reservoir chamber to thereby enable the piston to descend into said chamber.

19. The drug delivery system as defined in claim 15, wherein said piston has generally flat top and bottom faces and at least one side edge having a plurality of vertical grooves, and wherein the lower chamber having a vertically grooved wall, said grooves meshing in sliding engagement with the vertical grooves of the piston so as to provide a channel for the piston to follow when the piston descends upon the lower chamber.

20. The drug delivery system as defined in claim 15 wherein the ignition means further comprises a chip resistor which is heated by electrical current provided by one of the at least two electric leads.

21. The drug delivery system as defined in claim 14 wherein the transdermal diffusion device further comprises a reservoir pad whereby a drug in the drug reservoir chamber is forced from said chamber onto skin of a patient when the membrane is punctured from increasing pressure in the drug reservoir chamber when the piston descends on said chamber, and wherein said drug is prevented from flowing off the skin by the reservoir pad which maintains the drug in contact with the skin until absorbed.

22. The drug delivery system as defined in claim 15 wherein the transdermal diffusion device further comprises a reservoir pad whereby a drug in the drug reservoir chamber is forced from said chamber onto a rate controlling membrane which is in contact with skin and which enables gradual absorption of the drug.

23. The drug delivery system as defined in claim 15 wherein the fluid jet delivery device further comprises a narrow aperture whereby the drug in the drug reservoir chamber is forced from said chamber directly into a subcutaneous layer of a patient'"'"'s skin when the floor membrane is punctured from increasing pressure in the drug reservoir chamber when the piston descends on said chamber.

24. The drug delivery system as defined in claim 15 wherein the iontophoretic delivery device further comprises a reservoir pad and wherein a drug in the drug reservoir chamber is forced from said chamber when the floor membrane is punctured from increasing pressure in the drug reservoir chamber when the piston descends on said chamber, wherein said drug is prevented from flowing off the skin by the reservoir pad, and wherein electrodes from the drug storage and delivery module are in contact with the skin to thereby provide a weak electrical current thereto.

37. The drug delivery system as defined in claim 15 wherein the propellant charge further comprises a tetrazene-nitrocellulose-potassium chlorate and oxidizer mixture.

38. The drug delivery system as defined in claim 1 wherein the sterile pad coupled to the underside of the drug storage and delivery module has an adhesive surface for attachment to the limb.

39. The drug delivery system as defined in claim 1 wherein the drug storage and delivery module is contoured to couple to a patient'"'"'s arm, leg or torso to provide a reliable contact for drug administration.

40. The drug delivery system as defined in claim 39 wherein the drug storage and delivery module has a low profile to minimize interference with a patient'"'"'s activities when being worn.

41. The drug delivery system as defined in claim 1 wherein the propellant means comprises a propellant charge.

25. A multipathway automatic and on-demand drug delivery system for multiple administrations at selectable dispensing times of at least one type of drug, said system comprising:

a plurality of drug storage and delivery means wherein each has at least one drug storage reservoir and an actuable drug delivery system which receives a signal causing the drug delivery system to eject the at least one type of drug from the at least one drug storage reservoir, said plurality of drug storage and delivery means comprising;

an inner pod cylinder sealed at both ends and having a rigid cylindrical housing, wherein said inner pod comprises;

(i) a top lid has a lip extending horizontally from the side of said lid, (ii) a first gas entry port in a wall, (iii) a bottom lid from which a needle extends perpendicularly through an aperture, and (iv) a collapsible membrane anchored to the bottom lid and surrounding a needle inlet port that extends into the bottom lid, and wherein a drug is stored within said membrane;

an outer pod cylinder within which the inner pod cylinder fits in sliding engagement, wherein said outer pod comprises;

(i) an uppermost lid with a single gas vent, (ii) a flex circuit with a first and a second propellant charge thereon which is fixed to the bottom of said uppermost lid, (iii) a second lid with said single gas vent, (iv) a first propellant charge aperture positioned so as to encircle the first propellant charge that extends downward through said aperture, (v) a second propellant charge aperture positioned so as to encircle the second propellant charge that extends downward through said aperture, (vi) an L-shaped plug positioned to initially seal the single gas vent and to catch the horizontal lip of the inner pod when the inner pod descends a distance down through the outer pod, (vii) a recessed groove with a ledge on an outer pod inner wall to hold the L-shaped plug and allow vertical movement of the inner pod horizontal lip and the plug until said lip and said plug reach the ledge, (viii) a propellant gas passage through the outer pod inner wall that enables first propellant charge gas to enter, flow through said passage and enter the inner pod through the first gas entry port, (ix) a second bottom lid which seals the outer pod, with an aperture through said lid for the needle, (x) a needle guard that surrounds the injectable end of the needle, and (xi) a second propellant gas passage leading from the second propellant gas charge to flow underneath the inner pod;

a drug storage and delivery module which holds the plurality of drug storage and delivery means in position until ejection of the at least one type of drug therefrom;

a securing means for coupling the drug storage and delivery module to a patient; and

a control means which is coupled to the drug storage and delivery module and which transmits the signal causing the drug delivery system to eject the at least one type of drug at the selectable dispensing times.

26. The drug delivery system as defined in claim 25 wherein the needle guard comprises a silicone rubber septum.

27. A multipathway automatic and on-demand drug delivery system for multiple administrations at selectable dispensing times of at least one type of drug, said system comprising:

a plurality of drug storage and delivery means wherein each has at least one drug storage reservoir and an actuable drug delivery system which receives a signal causing the drug delivery system to eject the at least one type of drug from the at least one drug storage reservoir, said plurality of drug storage and delivery means comprising;

at least one straight and hollow cylindrical housing having an exterior and interior back end and front end;

a cylindrical hypodermic needle delivery pod which moves in sliding engagement within the length of the housing, and which is distally disposed from the front end of the housing before actuation;

means for injecting a hypodermic needle, which is coupled to the hypodermic needle delivery pod, through an aperture in the housing and into a patient, comprising;

a first pair of ignition leads coupled to the control means and which extend through the exterior and partially into the interior of the back end of the housing; and

ignition means disposed within and coupled to the two ignition leads in the interior of the housing for igniting a combustible propellant charge, the combustible propellant charge surrounding the ignition means and which will ignite responsive to the signal applied to the first pair of ignition leads, thereby forcing the hypodermic needle delivery pod toward the front end of the housing, and causing the hypodermic needle to penetrate a patient'"'"'s skin;

means for extracting the hypodermic needle from the patient after drug injection,

a drug storage and delivery module which holds the plurality of drug storage and delivery means in position until ejection of the at least one type of drug therefrom;

a securing means for coupling the drug storage and delivery module to a patient; and

a control means which is coupled to the drug storage and delivery module and which transmits the signal causing the drug delivery system to eject the at least one type of drug at the selectable dispensing times.

28. The drug delivery system as defined in claim 27 wherein the at least one straight and hollow cylindrical housing is disposed perpendicular to the arcuate angle of the drug storage and delivery module to thereby lie along a length thereof.

29. The drug delivery system as defined in claim 27 wherein the hypodermic needle delivery means is more specifically comprised of an aperture that has an opening which begins parallel to the length of and from within the housing interior at the front end and which forms an arcuate path that exits the housing at a right angle relative to the opening and which is directed out the underside of the drug storage and delivery module.

30. The drug delivery system as defined in claim 29 wherein the hypodermic needle delivery means is more specifically comprised of a hypodermic needle coupled to a drug reservoir within the hypodermic needle delivery pod, and extending from a front end of said pod and lying within the aperture but not extending therefrom.

31. The drug delivery system as defined in claim 30 wherein the means for extracting the hypodermic needle from the patient after drug injection is more specifically comprised of:

an electrical contact disposed at the front end of the housing interior and which generates a second signal when the drug delivery pod has made contact with the front end;

a second pair of ignition leads coupled to the control means and which extend through the exterior and partially into the interior of the front end of the housing;

second ignition means disposed within and coupled to the second pair of ignition leads in the front end of the interior of the housing for igniting a second combustible propellant charge; and

the second combustible propellant charge disposed to surround the ignition means and which will ignite responsive to the second signal, thereby forcing the hypodermic needle delivery pod toward the back end of the housing, causing the hypodermic needle to be extracted from the patients.

32. The drug delivery system as defined in claim 27 wherein the at least one straight and hollow cylindrical housing is disposed to extend perpendicularly from a plane of the patient'"'"'s leg or arm.

33. The drug delivery system as defined in claim 32 wherein the cylindrical hypodermic needle pod more specifically comprises a collapsible drug containment pouch and a hypodermic needle extending therefrom.

34. The drug delivery system as defined in claim 33 wherein the system further comprises:

a first chamber defined as a space bounded by the top of the housing, a generally circular wall and the hypodermic needle delivery pod, said first chamber initially holding a first expanding propellant gas from a first combustible propellant charge;

a second chamber defined as a space bounded by the hypodermic needle delivery pod, and in which the collapsible drug containment pouch is disposed;

a first propellant gas flow passageway from the first chamber to the second chamber which is open for gas flow after the hypodermic needle delivery pod is forced down the length of the housing by the expanding propellant gas in the first chamber;

a third chamber defined as a space bounded by the hypodermic needle delivery pod, a generally circular wall and the bottom of the housing, after the hypodermic needle delivery pod has completely descended in the housing;

a plug which is pulled down with the hypodermic needle delivery pod to expose a second propellant gas passageway from the first chamber to outside of the housing thereby enabling the first expanding propellant gas to escape from the housing when the hypodermic needle delivery pod is forced back to the top of the housing;

a fourth chamber in which a second combustible propellant charge is ignited to create a second expanding propellant gas; and

a third propellant gas flow passageway from the fourth chamber to the third chamber which enables the second expanding propellant gas to force the hypodermic needle delivery pod from the bottom of the housing back to the top of the housing.

35. The drug delivery system as defined in claim 34 wherein the means for injecting a hypodermic needle into the patient is more specifically comprised of a first propellant blister formed from a first combustible propellant charge and an electric circuit for igniting the first combustible propellant charge to thereby create the first expanding propellant gas.

36. The drug delivery system as defined in claim 35 wherein the means for extracting the hypodermic needle from the patient after drug injection is more specifically comprised of a second propellant blister formed from a second combustible propellant charge and a second electric circuit for igniting the second combustible propellant charge to thereby create the second expanding propellant gas.

42. A multipathway automatic and on-demand drug delivery system for multiple administrations at selectable dispensing times of at least one type of drug, said system comprising:

a plurality of drug storage and delivery means wherein each has at least one drug storage reservoir and an actuable drug delivery system which receives a signal causing the drug delivery system to eject the at least one type of drug from the at least one drug storage reservoir, said plurality of drug storage and delivery means comprising;

a first chamber for holding a first drug, wherein the first chamber is compressible to thereby eject a mixed drug from an ejection end thereof;

a second chamber for holding a second drug, wherein the second chamber is compressible to thereby eject the second drug therefrom;

a one-way port coupling the first chamber and the second chamber, whereby the second drug is introduced into the first chamber for mixing with the first drug to produce the mixed drug;

a first propellant charge for compressing the second chamber to force the second drug into the first chamber via the one-way port; and

a second propellant charge for compressing the first chamber to thereby eject the mixed drug therefrom via the ejection ends

a drug storage and delivery module which holds the plurality of drug storage and delivery means in position until ejection of the at least one type of drug therefrom;

a securing means for coupling the drug storage and delivery module to a patient; and

a control means which is coupled to the drug storage and delivery module and which transmits the signal causing the drug delivery system to eject the at least one type of drug at the selectable dispensing times.