Multipathway electronically-controlled drug delivery system

• US 6,165,155 A
• Filed: 01/16/1999
• Issued: 12/26/2000
• Est. Priority Date: 02/07/1997
• Status: Expired due to Term

• Current Assignee: SARCOS LC (Sarcos Technology & Robotics Corp.)
• Original Assignee: SARCOS LC (Sarcos Technology & Robotics Corp.)
• Inventors: Wyatt, Roland, Jacobsen, Stephen C., Petelenz, Tomasz J., Peterson, Stephen C.
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US09/232,579
• Time in Patent Office: 710 Days
• Field of Search: 604/156, 604/30, 604/65, 604/140, 604/31, 604/66-71, 604/118, 604/131, 604/151, 604/153, 604/246, 604/500
• 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 method for automatic or on-demand delivery of a drug to a patient, said method comprising the steps of:

a) providing a multipathway electronically-controlled drug delivery system comprising a drug storage and delivery module and a control means for activating the drug storage and delivery module to deliver a drug to a patient;

b) forming within the drug storage and delivery module a generally hollow dual-chambered delivery pod having an enclosed top face and bottom face, and where the chambers are generally arranged as an upper chamber and a lower chamber;

c) forming the upper chamber to function as a propellant chamber having a ceiling, a wall, and a collapsible floor;

d) providing a first combustible propellant charge in the propellant chamber;

e) providing an ignition means for igniting the combustible propellant charge;

f) disposing a piston located between the propellant chamber and the lower chamber;

g) forming the lower chamber to function as a drug reservoir chamber situated beneath the piston, said lower chamber having a puncturable floor membrane and

h) forming 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;

i) attaching the drug storage and delivery module to a patient; and

j) programming the control means to administer the desired drug or drugs in a single, continuous or periodic interval.

2. The method as defined in claim 1 wherein the method comprises the more specific step of selecting the drug delivery method from the group of delivery methods comprised of iontophoretic delivery, transdermal diffusion delivery, fluid jet delivery, hypodermic needle delivery, and pre-delivery drug mixing delivery.

3. The method as defined in claim 2 wherein the methods of iontophoretic delivery, transdermal diffusion delivery, fluid jet delivery and hypodermic needle injection delivery comprise the more specific steps of:

a) providing 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; and

b) coupling the ignition means to the at least two electric leads and covering the ignition means with the combustible propellant charge.

4. The method as defined in claim 3 wherein the method of transdermal diffusion delivery comprises the even more specific steps of:

a) sending a signal to the two electric leads to thereby ignite the first combustible propellant charge;

b) containing a resulting propellant gas within the upper chamber to thereby increase pressure within and cause the piston to compress a drug within the lower chamber;

c) providing an exit port on a side opposite the piston for the compressed drug of the lower chamber to escape; and

d) providing a pad to collect the drug ejected from the lower chamber in a contained area.

5. The method as defined in claim 4 wherein the method of iontophoretic delivery comprises the additional step of providing mild electrical stimulus to a patient'"'"'s skin to thereby increase drug absorption.

6. The method as defined in claim 2 wherein the method of fluid jet delivery comprises the more specific step of providing a jet exit port on a side opposite the piston for the compressed drug of the lower chamber to be delivered into subcutaneous layers of the patient'"'"'s skin for rapid absorption.

7. The method as defined in claim 2 wherein the method of hypodermic needle delivery comprises the more specific steps of:

a) forming a generally hollow multi-chamber delivery pod having an enclosed top and bottom face, and where the chambers are generally arranged as a first chamber, a second chamber and a third chamber;

b) forming the first chamber as a space bounded by the top face, a generally circular wall and a rigid hypodermic needle delivery pod;

c) forming the second chamber as a space bounded by the rigid hypodermic needle delivery pod, and disposing a collapsible drug containment pouch therein;

d) forming a first propellant gas flow passageway from the first chamber to the second chamber;

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

f) providing a plug which is pulled with the hypodermic needle delivery pod to expose a second propellant gas passageway from the first chamber to outside of the housing;

g) forming a fourth chamber in which a second combustible propellant charge is disposed; and

h) forming a third propellant gas flow passageway from the fourth chamber to the third chamber.

8. The method as defined in claim 7 wherein the method of hypodermic needle delivery comprises the more specific steps of:

a) igniting a first propellant charge in the first chamber, thereby forcing the rigid hypodermic needle delivery pod toward the bottom face and causing a needle to pierce the patient; and

b) moving past and thereby uncovering an opening of the first propellant gas flow passageway to enable the first expanding propellant gas to enter the hypodermic needle delivery pod and collapse the collapsible drug reservoir by forcing a drug out through the needle and into the patient.

9. The method as defined in claim 8 wherein the method comprises the additional steps of:

a) catching a lip of the plug to thereby remove the plug from the second propellant gas passageway; and

b) igniting a second propellant charge in the second chamber, and allowing a second expanding propellant gas to pass through the third propellant gas passageway, thereby forcing the rigid hypodermic needle delivery pod toward the top face and causing a needle to be extracted from the patient while the first expanding propellant gas is vented from the first chamber through the second propellant gas flow passageway.

10. The method as defined in claim 2 wherein the method of hypodermic needle injection comprises the additional steps of:

a) disposing the generally hollow dual-chambered delivery pod within a cylindrical enclosure, with a second propellant charge disposed at a top end of the cylindrical enclosure;

b) providing a hypodermic needle at the bottom of the delivery pod which follows an arcuate path through the housing, and which exits the housing at a right angle relative to the length of the delivery pod; and

c) providing a third propellant charge at a bottom end of the cylindrical enclosure.

11. The method as defined in claim 10 wherein the method of hypodermic needle injection delivery comprises the additional steps of:

a) igniting the second propellant charge to thereby drive the hypodermic needle into the patient by forcing the drug delivery pod from the top end of the cylindrical enclosure to the bottom end thereof;

b) igniting the first combustible propellant charge to thereby force the drug from the drug reservoir chamber and into the patient; and

c) igniting the third propellant charge to thereby force the drug delivery pod from the bottom end to the top end thereof, and thereby extracting the hypodermic needle from the patient.