Injection device with secondary reservoir

• US 7,645,264 B2
• Filed: 04/11/2005
• Issued: 01/12/2010
• Est. Priority Date: 04/11/2005
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Follman, Mark, Marsh, Ronald W., Browka, Edward P.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US11/102,874
• Publication Number:
  US 20060229562A1
• Time in Patent Office: 1,737 Days
• Field of Search: 435/69.1, 435/69.3, 435/190, 435/193, 435/196, 435/220, 604/506, 604/175, 604/28, 604/46, 604/502, 604/192, 604/239, 604/68, 604/70, 604/131, 604/288.02, 536/23.5, 536/23.4, 424/193.1
• US Class Current: 604/117
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/283 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/3155 by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A method and apparatus for injecting fluid into areas having high density tissue that creates a high backpressure resistance on the injection device is disclosed. The high backpressure resistance is overcome through a mechanical advantage achieved by using a secondary reservoir having a cross-sectional area smaller than the cross-sectional area of a primary reservoir. Exemplary injection device reservoir housings may comprise a primary reservoir, a secondary reservoir, a check valve, a septum penetrating cannula, travel limits, a pen needle connecting portion, sliding seal guide ribs, a sliding seal, a pen needle assembly, a needle stop, and a patient needle.

Claims

1. An injection mechanism for injecting fluid into a targeted tissue layer comprising:

a primary reservoir for storing fluid prior to injection having a first axis;

a secondary reservoir for holding the amount of fluid to be injected having a second axis, wherein the secondary reservoir is located co-axially and in series with the primary reservoir and has a smaller cross-sectional area than the cross-sectional area of the primary reservoir;

a needle connecting portion comprising a sliding seal, a needle assembly, and a needle stop, wherein the sliding seal comprises a needle septum forming one side of the secondary reservoir and through which the fluid to be injected passes from the collapsing secondary reservoir during the injection; and

a patient needle for intersecting the needle septum of the sliding seal, and for penetrating the skin of the patient to inject the fluid in the targeted tissue layer.

2. The injection mechanism of claim 1, wherein said patient needle has an exposed length of between approximately 0.5 mm and approximately 5 mm.

3. The injection mechanism of claim 1, wherein said patient needle has an exposed length of between approximately 0.5 mm and approximately 3.5 mm.

4. The injection mechanism of claim 1, wherein said patient needle has an exposed length of between approximately 1.5 mm and approximately 3.0 mm.

5. The injection mechanism of claim 1, wherein said patient needle delivers fluid in the intradermal or the shallow subcutaneous tissue space.

6. The injection mechanism of claim 1, further comprising:

a check valve located between the primary and secondary reservoirs for preventing fluid from leaking from the secondary reservoir back into the primary reservoir or medicament cartridge.

7. The injection mechanism of claim 1, wherein said secondary reservoir is filled with fluid causing said sliding seal to move proximal in said secondary reservoir.

8. The injection mechanism of claim 1, wherein the patient needle penetrates said patient skin until stopped by the needle stop, wherein said needle stop has an area larger than that of said patient needle.

9. The injection mechanism of claim 8, wherein an injection is administered by applying pressure to said primary reservoir thereby causing said fluid in said secondary reservoir to flow through said needle septum and patient needle to be injected into said intradermal tissue.

10. A method for injecting fluid into an intradermal tissue layer of a patient comprising the steps of:

transferring fluid from a primary reservoir with a first cross-sectional area into a secondary reservoir having a second cross-sectional area less than that of said first cross- sectional area;

preventing said fluid from flowing from the secondary reservoir back into the primary reservoir; and

pressurizing the fluid in said secondary reservoir to force it into said intradermal tissue layer of a patient.

11. The method of claim 10, further comprising the step of:

penetrating the skin of said patient with a needle in fluid communication with said secondary reservoir prior to said pressurizing step.

12. The method of claim 10, wherein the transferring step comprises turning a dosage knob to set the amount of fluid in the primary reservoir that is transferred to said secondary reservoir.

13. The method of claim 10, wherein said preventing step comprises using a check valve, wherein said check valve allows fluid to flow from the primary reservoir to the secondary reservoir and prevents the medication from substantially flowing from the secondary reservoir back into the primary reservoir.

14. The method according to claim 11, wherein the penetrating step comprises limiting the depth that the needle penetrates into the skin.

15. The method of claim 14, wherein the depth that the needle penetrates into the skin is limited by a needle stop.

16. An apparatus for delivery of compounds to the intradermal tissue of a patient'"'"'s skin, the apparatus comprising:

a reservoir housing having a distal end and a proximal end, and defining a primary reservoir, and a secondary reservoir in fluid communication;

a pen needle assembly mounted to the distal end of the reservoir housing;

a needle securely mounted to the pen needle assembly in fluid communication with the secondary reservoir and extending distally from the pen needle assembly; and

a needle stop having a skin-engaging surface disposed in a preselected position with respect to the pen needle assembly such that a preselected portion of the needle extends distally from the skin-engaging surface;

wherein the reservoir housing further comprises a lower sleeve slidingly engaged to an upper sleeve, and movable from a first position to a second position during injection; and

wherein, when the lower sleeve is in the first position, the secondary reservoir has a first volume and when the lower sleeve is in the second position, the secondary reservoir has a second volume, and wherein the second volume is less than the first volume.

17. The apparatus of claim 16, wherein the pen needle assembly is selectively and directly mounted to the reservoir housing.

18. The apparatus of claim 16, wherein the pen needle assembly is fixedly mounted to the reservoir housing.

19. The apparatus of claim 16, wherein the needle stop is integrally formed with either the pen needle assembly or the reservoir housing.

20. An apparatus for delivery of compounds to the intradermal tissue of a patient'"'"'s skin, the apparatus comprising:

a reservoir housing having a distal end and a proximal end, and defining a primary reservoir, and a secondary reservoir in fluid communication;

a pen needle assembly mounted to the distal end of the reservoir housing;

a needle securely mounted to the pen needle assembly in fluid communication with the secondary reservoir and extending distally from the pen needle assembly; and

a needle stop having a skin-engaging surface disposed in a preselected position with respect to the pen needle assembly such that a preselected portion of the needle extends distally from the skin-engaging surface;

wherein the reservoir housing further comprises a lower sleeve slidingly engaged to an upper sleeve, and movable from a first position to a second position; and

a sliding seal operably engaged to the lower housing and disposed, at least in part, within the secondary reservoir for sliding movement.

21. The apparatus of claim 20, wherein the pen needle assembly is selectively and directly mounted to the reservoir housing.

22. The apparatus of claim 20, wherein the pen needle assembly is fixedly mounted to the reservoir housing.

23. The apparatus of claim 20, wherein the needle stop is integrally formed with either the pen needle assembly or the reservoir housing.