Injector

• US 9,550,025 B2
• Filed: 03/25/2011
• Issued: 01/24/2017
• Est. Priority Date: 03/25/2010
• Status: Active Grant

• Current Assignee: Sensile Medical AG (Gerresheimer AG)
• Original Assignee: New Injection Systems Ltd.
• Inventors: Dunne, Stephen Terence
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/637,053
• Publication Number:
  US 20130197475A1
• Time in Patent Office: 2,132 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

An injector for delivering medicament comprises a collapsible container (1002) for containing the liquid medicament, a normally-closed valve (1004) coupled to the collapsible container (1002) for retaining the liquid medicament within the collapsible container and an injection means (1006) for delivering the liquid medicament from the collapsible container. The liquid medicament is maintained under pressure by a pressurizing means (1003) which pressurizes the liquid medicament such that it is delivered by the injection means (1006) when the normally-closed valve (1004) is opened.

Claims

1. An injector for delivering a liquid medicament comprising:

a collapsible container for containing the liquid medicament, a normally-closed valve coupled to the collapsible container for retaining the liquid medicament within the collapsible container;

an injection means coupled to the normally-closed valve for delivering the liquid medicament from the collapsible container;

pressurising means for maintaining the liquid medicament contained within the collapsible container under pressure during storage before actuation of the injector, such that the liquid medicament is delivered by the injection means when the normally-closed valve is opened; and

an actuator for opening the normally-closed valve, in which the normally-closed valve opens in response to the actuator being pressed against a patient'"'"'s skin;

wherein, when the normally-closed valve is opened, the liquid medicament is delivered by the injection means due to the pressure from the pressurising means.

2. An injector according to claim 1 in which the injection means is a hollow needle, the hollow needle being a hypodermic needle.

3. An injector according to claim 1 in which the collapsible container and the pressurising means are housed within a rigid container.

4. An injector according to claim 3 in which at least a portion of the rigid container is transparent.

5. An injector according to claim 3 in which the rigid container includes a vent to allow displaced air within the rigid container to escape when the collapsible container is filled.

6. An injector according to claim 3 in which the rigid container is hermetically sealed.

7. An injector according to claim 6 in which the rigid container has an inert gas atmosphere surrounding the collapsible container.

8. The injector according to claim 3 wherein the normally-closed valve is connected to the rigid container.

9. The injector according to claim 4 wherein the rigid container is formed from a transparent polymer or glass.

10. The injector according to claim 5 wherein the vent is a closable vent.

11. The injector according to claim 7 wherein the inert gas has a low solubility in the liquid medicament.

12. The injector according to claim 11 wherein the inert gas is nitrogen.

13. An injector according to claim 1 in which the collapsible container is defined by internal walls of the rigid container and a piston that is slidably arranged within the rigid container, the volume of the collapsible container varying depending on the position of the piston.

14. An injector according to claim 1 in which the collapsible container is a bellows coupled to the normally-closed valve.

15. An injector according to claim 14 in which the bellows is formed from a transparent material.

16. An injector according to claim 1 in which the pressurising means is a biasing element that exerts a force that acts on the collapsible container.

17. An injector according to claim 16 in which the force acting to collapse the collapsible container is generated by a spring.

18. An injector according to claim 17 in which the pressurising means comprises a spring and is an integral part of the collapsible container.

19. The injector according to claim 17 wherein the spring is a helical spring arranged to urge the collapsible container to collapse.

20. The injector according to claim 17 wherein the spring comprises a plastic spring.

21. An injector according to claim 16 in which the force that acts on the collapsible container is generated by a compressed gas or a liquefied gas.

22. An injector according to claim 16 in which the pressurising means comprises a piston or ram that is urged by the force into contact with the collapsible container.

23. An injector according to claim 1 in which the normally-closed valve is a continuous flow valve or an aerosol valve.

24. An injector according to claim 1 in which the normally-closed valve comprises a spring that acts to urge the valve to a closed position, in which the spring is a non-metallic spring.

25. An injector according to claim 1 in which the injection means is a needle and the normally-closed valve is arranged to open when the needle has been inserted a predetermined distance into the patient, the predetermined distance depending on the type of drug that is being delivered and the tissue that the delivery is required to be made into.

26. An injector according to claim 1 in which the injector means is a needle and the injector comprises a protective sleeve or shield.

27. An injector according to claim 1 when filled with the liquid medicament.

28. An injector comprising:

a collapsible container retaining a liquid medicament by a normally-closed valve; and

a needle for injecting the liquid medicament coupled to the normally-closed valve;

a force arranged for maintaining the liquid medicament retained within the collapsible container under pressure during storage before actuation of the injector, such that the liquid medicament is delivered through the needle when the normally-closed valve is opened; and

an actuator for opening the normally-closed valve, in which the normally-closed valve opens in response to the actuator being pressed against a patient'"'"'s skin;

wherein, when the normally-closed valve is opened, the liquid medicament is delivered by the needle due to the pressure from the force.

29. An injector according to claim 28 in which at least an inner surface of the collapsible container is formed from a polymer and the normally-closed valve is formed from a polymer such that the liquid medicament is does not come into contact with any metallic component while retained within the collapsible container.

30. An injector according to claim 28 in which the liquid medicament does not contact the needle until the normally-closed valve is opened to deliver the liquid medicament.

31. An injector according to claim 28 in which the liquid medicament comprises a constituent classified within one of the following categories of pharmaceuticals or biopharmaceuticals:

Alpha1-Adrenergic Antagonists, Analgesic Agents, Anaesthetics, Angiotensin Antagonists, Anti-Inflammatory Agents, Antianxiety Agents, Antiarrhythmics, Anticholinergics, Anticoagulants, Anticonvulsants, Antidiarrheal Agents, Antihistamines, Antineoplastics and Antimetabolites, Antineoplastics and Antimetabolites, Antiplasticity Agents, Antiulcer Agents, Beta-Adrenergic Antagonists, Bisphosphonates, Bronchodilators, Cardiac Inotropes, Cardiovascular Agents, Central Acting Alpha2-stimulants, Contrast Agents, Converting Enzyme Inhibitors, Dermatologies, Diuretics, Drugs for Erectile Dysfunction, Drugs of Abuse, Endothelin Antegonists, Hormonal Agents and Cytokines, Hypoglycemic Agents, Hypouricemic Agents and Drugs Used For Gout, Immunosuppressants, Lipid Lowering Agents, Miscellaneous, Psychotherapeutic Agents, Renin Inhibitors, Serotonergic Antagonist, Steroids, Sympathomimetics, Thyroid and Antithyroid Agents, Vasodilators, Vasopeptidase Inhibitors, Salines, Insulins, Blood factors, Thrombolytic agents, Hormones, Haematopoietic growth factors, Interferons, Interleukin-based products, Vaccines, Monoclonal antibodies, Tumour necrosis factors, Therapeutic enzymes, Antibody-drug conjugates, Biosimilars, Erythropoietin, Immunoglobulin, Blood and Blood components, Allergenics, Somatic cells, Gene therapy, Tissues, and Recombinant therapeutic proteins.

32. An injector according to claim 28 that is a hand-held injector.

33. An injector according to claim 28 in which the dead volume of the collapsible container and the normally-closed valve are low enough to ensure that more than 85% of the liquid medicament contained within the collapsible container can be delivered.

34. The injector according to claim 33 wherein more than 90% of the liquid medicament contained within the collapsible container can be delivered.

35. The injector according to claim 33 wherein more than 95% of the liquid medicament contained within the collapsible container can be delivered.

36. The injector according to claim 33 wherein more than 97% of the liquid medicament contained within the collapsible container can be delivered.

37. A method of injecting a liquid medicament, the liquid medicament being retained within a collapsible container of an injector by a normally-closed valve, the injector comprising an actuator for opening the normally-closed valve and a needle coupled to the normally-closed valve and used for injecting the liquid medicament, the actuator when pressed against a patient'"'"'s skin opening the normally-closed valve, the method comprising the steps of:

positioning the needle of the injector to deliver the liquid medicament to a patient, whereby a force is arranged for maintaining the liquid medicament under pressure during storage before actuation of the injector, such that the liquid medicament is delivered through the needle when the normally-closed valve is opened; and

pressing the actuator against skin of the patient, from which the normally-closed valve opens, whereby the liquid medicament is injected due to the pressure from the force.

38. A method according to claim 37 in which the normally-closed valve is opened automatically when the injector is positioned correctly for delivery.

39. A method according to claim 38 in which the normally-closed valve is actuated when the needle is inserted into the patient to a predetermined depth.

40. A method of manufacturing an injector for delivering a liquid medicament comprising the steps of:

coupling a normally-closed valve to a collapsible container for containing the liquid medicament;

opening the normally-closed valve;

filling the collapsible container with the liquid medicament through the normally-closed valve, thereby causing the collapsible container to expand and deflect a pressurising means;

closing the normally-closed valve to retain the liquid medicament within the collapsible-container, the liquid medicament within the collapsible container being maintained under pressure during storage before actuation of the injector due to the pressurising means; and

coupling the normally-closed valve to an injection means for delivering the liquid medicament from the collapsible container when the normally-closed valve is opened;

wherein the injection means comprises an actuator for opening the normally-closed valve, the actuator when pressed against a patient'"'"'s skin opens the normally-closed valve, and when the normally-closed valve is opened, the liquid medicament is delivered by the injection means due to the pressure from the pressurising means.

41. A method according to claim 40 further comprising the step of applying a vacuum to the collapsible-container through the normally-closed valve to remove air trapped within the collapsible container and the normally-closed valve prior to filling.

42. A method according to claim 40 in which the normally-closed valve is flushed with a sterilising fluid, prior to coupling to the injection means.

43. The method according to claim 42 wherein the sterilizing fluid comprises ethanol.

44. A method according to any of claim 40 in which air is evacuated from the rigid container.

45. The method according to claim 44 wherein the air is replaced by an inert gas.