Method and device for painless injection of medication

• US 7,637,891 B2
• Filed: 09/12/2003
• Issued: 12/29/2009
• Est. Priority Date: 09/12/2002
• Status: Expired due to Fees

• Current Assignee: Children's Hospital & Medical Center
• Original Assignee: Children's Hospital & Medical Center
• Inventors: Wall, Eric James
• Primary Examiner(s): Desanto; Matthew F
• Application Number:
  US10/605,187
• Publication Number:
  US 20040116847A1
• Time in Patent Office: 2,300 Days
• Field of Search: 604/890.1, 604/891.1, 604131-135, 604/140, 604/141, 604145-154, 604/156, 604/157, 604/892.1
• US Class Current: 604/131
• 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: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• 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 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• 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 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• 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 5/422 Desensitising skin
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A device for painlessly injecting medications, and a method for providing a substantially painless injection of medication into a patient that does not require the use of an anesthetic, that does not require the medical personnel to spend a substantial amount of time performing the injection procedure, that is relatively simple and inexpensive to perform and operate, and that provides a relatively high degree of safety for both the medical personnel and for the patient. The injection needle can have an outside diameter greater than 0.20 mm and less than about 0.38 mm. The medicament can be injected painlessly through the needle and into the patient at a substantially constant volumetric flow rate of about 0.05 μL/s to about 50 μL/s.

Claims

1. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base for attachment to the skin of a patient,

b) an injection needle disposed substantially perpendicular to the base and within the housing, the needle having an outside diameter less than about 0.38 mm, an inlet end and an opposed injection end, and being configured for axial movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base,

c) a reservoir containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position,

f) a means for pumping the medicament from the reservoir to the injection end of the injection needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s.

2. The device according to claim 1 wherein the volumetric flow rate is from about 1 μ

L/s to about 4 μ

L/s.

3. The device according to claim 1 wherein the means for pumping the medicament is selected from the group consisting of a mechanical pumping means, a pneumatic pumping means, an electronic means, and an electro-mechanical pumping means.

4. The device according to claim 1 further comprising a means for pre-selecting the depth of insertion of the injection needle at its second position.

5. The device according to claim 1 further comprising a means for retracting the injection needle from its second position to a third position within the housing.

6. A device according to claim 1, wherein the base includes a means for attaching the base of the self-contained device for semi-permanent attachment to the skin of the patient, the attaching means being configured wherein during the pumping step, a person is not required to hold the device.

7. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base for attachment to the skin of a patient,

b) an injection needle disposed within the housing, the needle having an outside diameter greater than 0.20 mm and less than about 0.32 mm, having an inlet end and an opposed injection end, and being configured for movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends through the base,

c) a reservoir containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position,

f) a means for pumping the medicament from the reservoir to the injection end of the injection needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s.

8. The device according to claim 7 wherein the volumetric flow rate is from about 1 μ

L/s to about 4 μ

L/s.

9. The device according to claim 7 wherein the means for pumping the medicament is selected from the group consisting of a mechanical pumping means, a pneumatic pumping means, an electronic means, and an electromechanical pumping means.

10. The device according to claim 7 wherein the injection needle disposed in its first position substantially perpendicular to the base.

11. The device according to claim 7 further comprising a means for pre-selecting the depth of extension of the injection needle at its second position.

12. A device according to claim 7, wherein the base includes a means for attaching the base of the self-contained device for semi-permanent attachment to the skin of the patient, the attaching means being configured wherein during the pumping step, a person is not required to hold the device.

15. The device according to claim 7 further comprising a means for pre-selecting the depth of extension of the injection needle at its second position.

13. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base for attachment to the skin of a patient,

b) an injection needle disposed substantially perpendicular to the base and within the housing, the needle having an outside diameter less than about 0.038 mm, an inlet end and an opposed injection end, and being configured for axial movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base,

c) an empty reservoir for receiving and containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position,

f) a means for pumping the medicament from the reservoir to the injection end of the injection needle at a substantially constant volumetric flow rate of from about 1 μ

L/s to about 4 μ

L/s.

14. The device according to claim 13 wherein the means for pumping the medicament is selected from the group consisting of a mechanical pumping means, a pneumatic pumping means, an electronic means, and an electro-mechanical pumping means.

16. A device according to claim 13, wherein the base includes a means for attaching the base of the self-contained device for semi-permanent attachment to the skin of the patient, the attaching means being configured wherein during the pumping step, a person is not required to hold the device.

17. A self-contained, automatically-sequencing device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base for attachment to the skin of a patient,

b) an injection needle disposed within the housing, the needle having an outside diameter less than about 0.38 mm, an inlet end and an opposed injection end, and being configured for movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base to a distance sufficient for instramuscular insertion thereof,

c) a reservoir containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position,

f) a means for pumping the medicament from the reservoir to the injection end of the needle, wherein the pumping means pumps the medicament at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s,

g) a means for retracting the injection needle from its second position to a third position within the housing, and

h) a means for automatically sequencing and activating the inserting means, the pumping means and the retracting means.

18. The automatically-sequencing device according to claim 17 wherein the inserting means and the retracting means, independently, are selected from the group consisting of a mechanical means, a pneumatic means, an electronic means, and an electro-mechanical means.

19. A device according to claim 17, wherein the base includes a means for attaching the base of the self-contained device for semi-permanent attachment to the skin of the patient, the attaching means being configured wherein during the pumping step, a person is not required to hold the device.

20. A self contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base that includes a means for semi-permanent attachment of the device to the skin of a patient,

b) an injection needle disposed substantially perpendicular to the base and within the housing, the needle having an injection end, and configured for axial movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base to a distance sufficient for intramuscular insertion thereog the injection needle having an outside diameter greater than 0.20 mm and less than about 0.38 mm,

c) a reservoir containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position, and

f) a means for pumping the medicament from the reservoir to the injection end of the needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s.

21. The device according to claim 20 further comprising a means for retracting the injection needle from its second position to a third position within the housing.

22. The device according to claim 21 wherein the inserting means, the pumping means, and the retracting means are configured for automatically and sequentially:

a. extending the needle from its first position within the housing to its second position into the patient;

b. injecting the medicine via the needle into the patient; and

c. retracting the needle from its second position in the patient to a third position within the housing.

23. The device according to claim 20 wherein the insertion distance from the base is at least 5 mm.

24. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base that includes a means for semi-permanent attachment of the device to the skin of a patient,

b) an injection needle disposed substantially perpendicular to the base and within the housing, the needle having an outside diameter less than about 0.38 mm, an inlet end and an opposed injection end, and configured for axial movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base to a distance sufficient for intramuscular insertion thereof,

c) a reservoir containing a liquid medicament, disposed within the housing along a line extending axially from the inlet end of the injection needle,

d) a means for inserting the injection needle to its second position, and

e) a reservoir urging means for moving the reservoir into liquid communication with the inlet end of the injection needle,

f) a means for pumping the medicament from the reservoir to the injection end of the needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s, and

g) a means for retracting the injection needle from its second position to a third position within the housing.

25. The device according to claim 24 wherein the injection needle has an outside diameter greater than 0.20 mm.

26. The device according to claim 24 where the inserting means is selected from the group consisting of a mechanical means, a pneumatic means, an electronic means, and an electro-mechanical means, and the reservoir urging means is selected from the group consisting of a mechanical means, a pneumatic means, an electronic means, and an electro-mechanical means.

27. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base that includes a means for semi-permanent attachment of the device to the skin of a patient,

b) an injection needle disposed substantially perpendicular to the base and within the housing, the needle having an injection end, and configured for axial movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base to a distance sufficient for intramuscular insertion thereof, the injection needle having an outside diameter greater than 0.20 mm and less than about 0.38 mm,

c) an empty reservoir for receiving and containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position, and

f) a means for pumping the medicament from the reservoir to the injection end of the needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s.

28. The device according to claim 27 wherein the volumetric flow rate is from about 1 μ

L/s to about 4 μ

L/s.

29. The device according to claim 27 wherein the injection needle has a size from 30 gauge to 33 gauge.

30. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base for attachment to the skin of a patient,

b) an injection needle disposed within the housing, the needle having an outside diameter greater than 0.20 mm and tess than about 0.32 mm, having an inlet end and an opposed injection end, and being configured for movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends through the base,

c) an empty reservoir for receiving and containing a liquid medicament,

d) a means for liquid communication between the reservoir and the injection needle,

e) a means for inserting the injection needle to its second position,

f) a means for pumping the medicament from the reservoir to the injection end of the injection needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s.

31. The device according to claim 30 wherein the volumetric flow rate is from about 1 μ

L/s to about 4 μ

L/s.

32. The device according to claim 30 wherein the needle disposed substantially perpendicular to the base.

33. The device according to claim 30 wherein the injection end of the needle in the second position extends outwardly from the base to a distance sufficient for intramuscular insertion thereof.

34. The device according to claim 30 wherein the base includes a means for attaching the base of the self-contained device for semi-permanent attachment to the skin of the patient.

35. A self-contained device for painless, intramuscular injection of a liquid medicament, comprising:

a) a housing having a base for attachment to the skin of a patient,

b) an injection needle disposed within the housing, the needle having an outside diameter of about 0.36 mm and less, an inlet end and an opposed injection end, and being configured for axial movement between a first position wherein the injection end is within the housing and a second position wherein the injection end extends outwardly from the base to a distance sufficient for intramuscular insertion thereof,

c) an empty reservoir for receiving and containing a liquid medicament and in liquid communication with the injection needle,

d) a means for inserting the injection needle to its second position,

e) a means for pumping the liquid medicament from the reservoir to the injection cnd of the injection needle at a substantially constant volumetric flow rate of from about 0.5 μ

L/s to about 20 μ

L/s.

36. The device according to claim 35 wherein the volumetric flow rate is from about 1 μ

L/s to about 4 μ

L/s.

37. The device according to claim 35 wherein the needle disposed substantially perpendicular to the base.

38. The device according to claim 35 wherein the base includes a means for attaching the base of the self-contained device for semi-permanent attachment to the skin of the patient.