Method and apparatus for initiating reperfusion treatment by an unattended individual undergoing heart attack symptoms

• US 4,658,830 A
• Filed: 08/08/1984
• Issued: 04/21/1987
• Est. Priority Date: 08/08/1984
• Status: Expired due to Term

• Current Assignee: Meridian Medical Technologies Incorporated
• Original Assignee: Survival Technology, Inc. (Meridian Medical Technologies Incorporated)
• Inventors: Sarnoff, Stanley J.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/638,695
• Time in Patent Office: 986 Days
• Field of Search: 604/136, 604/137, 604/138, 604/139, 128/696, 128/904
• US Class Current: 600/509
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/13 Amines A61K31/04 takes precedence
• CPC Class Codes: A61K 31/15 Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) ; Imines (C—N=C)
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/415 1,2-Diazoles
• CPC Class Codes: A61K 33/02 Ammonia; Compounds thereof
• CPC Class Codes: A61K 38/38 Albumins
• CPC Class Codes: A61K 38/446 Superoxide dismutase (1.15)
• CPC Class Codes: A61K 38/49 Urokinase; Tissue plasminogen activator
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• 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 5/2066 comprising means for injection of two or more media, e.g. by mixing

Abstract

A device for initiating reperfusion treatment of a coronary prone individual prior to the establishment of qualified direct contact personal care at a time during the early minutes or hours after the onset of heart attack symptoms and after qualified personnel have participated by telephone in the decision to initiate such treatment. The device comprises an automatic injector assembly including a releasable force applying assembly, a safety normally disposed in a release preventing position movable therefrom into a release permitting position, a container or containers for separately containing a plurality of separate medicament dosages including a first dosage containing a clot selective coronary thrombolytic agent and a separate second dosage containing a cardiac antiarrhythmic agent and one or more hypodermic needles. The automatic injector is operable in response to a predetermined manual actuating procedure including the movement of the safety into its release permitting position for effecting release of the releasable force applying assembly and causing the released force to be applied so as to effect the movement of the hypodermic needle or needles into the muscle tissue of the individual and the flow of the separate medicament dosages outwardly from the container or containers through the hypodermic needle or needles into the muscle tissue of the individual.

Claims

1. In a method of initiating life saving treatment of a coronary prone individual undergoing heart attack symptoms at a time during the early minutes or hours after the onset of the heart attack symptoms with the use of a self-injecting unit containing a medicament, said method comprising the steps of determining during the aforesaid time after the onset of heart attack symptoms that the symptoms being experienced by the individual are such as to warrant the injection of said medicament from said self-injecting unit into the individual and then injecting the medicament from said self-injecting unit into the muscle tissue of the individual undergoing the heart attack symptoms,

the improvement which renders said method capable of limiting damage to the myocardium of the individual undergoing the heart attack symptoms as a result of coronary thrombosis by establishing reperfusion,

said improvement comprising performing the aforesaid steps with a self-injecting unit having a medicament therein which includes a clot selective coronary thrombolytic agent capable of being absorbed into the blood stream from an injection site in the muscle tissue of the individual undergoing the heart attack symptoms in sufficient quantity to establish reperfusion when accomplished within a time sufficiently early after onset of the heart attack symptoms.

2. A method as defined in claim 1 wherein said clot selective coronary thrombolytic agent includes t-PA.

3. A method as defined in claim 2 wherein said medicament also includes an absorption enhancing agent for said t-PA.

4. A method as in claim 3 wherein said absorption enhancing agent is hydroxylamine hydrochloride.

5. A method as defined in claim 3 wherein said medicament also includes a cardiac antiarrhythmic agent.

6. A method as defined in claim 5 wherein said cardiac antiarrythmic agent is lidocaine.

7. A method as defined in claim 1 wherein said medicament also includes a cardiac antiarrhythmic agent.

8. A method as defined in claim 7 wherein said cardiac antiarrythmic agent is lidocaine.

9. A method as defined in claim 1 wherein the injecting step includes injecting the medicament into the muscle tissue of the calf of the individual.

10. In a method of initiating life saving treatment of a coronary prone individual prior to the establishment of qualified direct contact personal care at a time during the early minutes or hours after the onset of heart attack symptoms with the use of apparatus comprising a heart monitoring device and an automatic injector assembly, said heart monitoring device comprising electrode means for connection with the individual in a position to sense the electrical activity triggering the individual'"'"'s heart beats and means for establishing signals corresponding to the electrical activity sensed by said electrode means capable of being transmitted over a telephone communication line established with a station having information and qualified personnel sufficient to make a decision based upon the signals transmitted and the oral communications transmitted in regard to the individual'"'"'s symptoms as to the initiation of the treatment by the individual, said automatic injector assembly including releasable force applying means, safety means normally disposed in a release preventing position movable therefrom into a release permitting position, means for separately containing a medicament, hypodermic needle means, and means operable in response to a predetermined manual actuating procedure including the movement of said safety means into said release permitting position for effecting release of said releasable force applying means and causing the released force to be applied so as to effect (1) the movement of said hypodermic needle means into the muscle tissue of the individual undergoing the heart attack symptoms and (2) the flow of medicament within said containing means outwardly thereof through said hypodermic needle means into the muscle tissue of the individual undergoing the heart attack symptoms, said method comprising the steps of:

connecting said electroce means to the individual undergoing the heart attack symptoms, establishing a telephone communication line to said station and transmitting thereover the signals established by said signal establishing means, receiving a communication over said telephone communication line indicative of a decision to initiate the treatment, and then performing the predetermined manual actuating procedure with respect to said automatic injector assembly in relation to the individual undergoing the heart attack symptoms so as to (1) move said hypodermic needle means into the muscle tissue of the individual and (2) flow medicament outardly from said containing means through said hypodermic needle means into the muscle tissue of the individual,

the improvement which renders said method capable of limiting damage to the myocardium of the individual undergoing the heart attack symptoms as a result of coronary thrombosis by establishing reperfusion,

said improvement comprising performing the aforesaid steps with an automatic injector assembly having a medicament therein which includes a clot selective coronary thrombolytic agent capable of being absorbed into the blood stream from an injection site in the muscle tissue of the individual undergoing the heart attack symptoms in sufficient quantity of establish reperfusion when accomplished within a time sufficiently early after onset of the heart attack symptoms.

11. A method as defined in claim 10 wherein said clot selective coronary thrombolytic agent includes t-PA.

12. A method as defined in claim 11 wherein said medicament also includes an absorption enhancing agent for said t-PA.

13. A method as in claim 12 wherein said absorption enhancing agent is hydroxylamine hydrochloride.

14. A method as defined in claim 12 wherein said medicament also includes a cardiac antiarrythmic agent.

15. A method as defined in claim 14 wherein said cardiac antiarrythmic agent is lidocaine.

16. A method as defined in claim 10 wherein said medicament also includes a cardiac antiarrythmic agent.

17. A method as defined in claim 16 wherein said cardiac antiarrythmic agent is lidocaine.

18. A method as defined in claim 10 wherein the injecting step includes injecting the medicament into the muscle tissue of the calf of the individual.